Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2026-01-18 @ 6:55 PM
Study NCT ID:
NCT04176705
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fractional Ablative Laser Treatment for Skin Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jkbailey@wakehealth.edu', 'phone': '(336) 716-8002', 'title': 'John Bailey, MD', 'organization': 'Wake Forest University Health Sciences'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Laser', 'description': 'Lidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'No Laser', 'description': 'Lidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'death', 'notes': 'cardiovascular embarrassment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Contracture of Scar Surface Area (Percentage of Original Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '97', 'spread': '14', 'groupId': 'OG000'}, {'value': '97', 'spread': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post-grafting', 'description': 'Contracture of Scar Surface Area 90 days post grafting: The surface area of the skin graft cm\\^2 at about 90 days after skin grafting will be compared to the size of the original skin graft at about one week after surgery.', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area', 'populationDescription': 'One subject withdrew after signing consent.'}, {'type': 'PRIMARY', 'title': 'Contracture of Scar Surface Area (Percentage of Original Area)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-grafting', 'description': 'Contracture of Scar Surface Area 1 year post grafting: The surface area of the skin graft cm\\^2 at about one year after skin grafting will be compared to the size of the original skin graft at about one week after surgery.', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Scar Roughness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'timeFrame': '90 days post-grafting', 'description': 'Scar Roughness at 9 weeks and 12 weeks post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis. A three-dimensional analysis of the molds will allow for measure of average roughness. The machine used will provide a digital read out which will then be averaged to obtain a mean value. This will allow for comparison between treated and control grafts at 90 days and one year.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area', 'populationDescription': 'Data could not be collected. Unable to acquire molding due to COVID supply chain challenges.'}, {'type': 'SECONDARY', 'title': 'Scar Roughness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'timeFrame': '1 year post-grafting', 'description': 'Scar Roughness 10-12 months post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis. A three-dimensional analysis of the molds will allow for measure of average roughness. The machine used will provide a digital read out that will then be averaged to obtain a mean value. This will allow for comparison between treated and control grafts at 90 days and one year.', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area', 'populationDescription': 'Data could not be collected. Unable to acquire molding due to COVID supply chain challenges.'}, {'type': 'SECONDARY', 'title': 'Biomechanics Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '206', 'spread': '143', 'groupId': 'OG000'}, {'value': '231', 'spread': '187', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post-grafting', 'description': "Biomechanics Stiffness 90 days post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.", 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Biomechanics Stiffness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '283', 'spread': '69', 'groupId': 'OG000'}, {'value': '301', 'spread': '48', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post-grafting', 'description': "Biomechanics Stiffness 10-12 months post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.", 'unitOfMeasure': 'kPa', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Biomechanics Elasticity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.66', 'spread': '0.31', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post-grafting', 'description': "Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer. The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Biomechanics Elasticity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.71', 'spread': '0.28', 'groupId': 'OG000'}, {'value': '0.71', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post-grafting', 'description': "Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer. The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value.", 'unitOfMeasure': 'millimeters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Erythema Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '379', 'spread': '117', 'groupId': 'OG000'}, {'value': '360', 'spread': '101', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post-grafting', 'description': 'Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Erythema Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '425', 'spread': '35', 'groupId': 'OG000'}, {'value': '384', 'spread': '34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post-grafting', 'description': 'Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Vancouver Scar Scale (VSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '4.7', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post-grafting', 'description': 'Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, \\<2mm=1, 2-5mm=2, \\>5mm=3; Lowest possible score= 0 and Highest Score possible = 13. Higher results denotes worse outcomes.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Vancouver Scar Scale (VSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-grafting', 'description': 'Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, \\<2mm=1, 2-5mm=2, \\>5mm=3; Lowest possible score= 0 and Highest Score possible = 13. Higher results denotes worse outcomes.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Patient and Observer Scar Assessment Scale (POSAS)--Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '36', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post-grafting', 'description': 'Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Patient and Observer Scar Assessment Scale (POSAS)--Observer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '90 days post-grafting', 'description': 'Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Patient and Observer Scar Assessment Scale (POSAS)--Patient', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-grafting', 'description': 'Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Patient and Observer Scar Assessment Scale (POSAS)--Observer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-grafting', 'description': 'Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.25', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '1.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 days post-grafting', 'description': 'Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}, {'type': 'SECONDARY', 'title': 'Patient-Reported Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'units': 'skin burn area', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'OG001', 'title': 'No Laser', 'description': 'Split person design.\n\nLidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year post-grafting', 'description': 'Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.', 'unitOfMeasure': 'score on a scale', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'skin burn area', 'denomUnitsSelected': 'skin burn area'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laser', 'description': 'Lidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.\n\nFractional Ablative Laser: Applied to only site that is randomized to laser intervention'}, {'id': 'FG001', 'title': 'No Laser', 'description': 'Lidocaine Cream: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.\n\nTriamcinolone Acetonide Cream: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '9', 'numSubjects': '9'}, {'groupId': 'FG001', 'numUnits': '9', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '1', 'numSubjects': '1'}, {'groupId': 'FG001', 'numUnits': '1', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '8', 'numSubjects': '8'}, {'groupId': 'FG001', 'numUnits': '8', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'typeUnitsAnalyzed': 'skin burn areas', 'preAssignmentDetails': 'Each of the nine subjects had two burned areas. One area was treated with laser and the other area was not treated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall Participants', 'description': 'This is a split person design. Overall participants in both arms are included here.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of nine subjects were enrolled. Each of the nine subjects had two burned areas. Each had one area treated with laser and the other area was not treated.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-12-30', 'size': 897754, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-01T11:57', 'hasProtocol': True}, {'date': '2023-01-09', 'size': 241547, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-11-01T15:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-06', 'studyFirstSubmitDate': '2019-11-20', 'resultsFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-06', 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contracture of Scar Surface Area (Percentage of Original Area)', 'timeFrame': '90 days post-grafting', 'description': 'Contracture of Scar Surface Area 90 days post grafting: The surface area of the skin graft cm\\^2 at about 90 days after skin grafting will be compared to the size of the original skin graft at about one week after surgery.'}, {'measure': 'Contracture of Scar Surface Area (Percentage of Original Area)', 'timeFrame': '1 year post-grafting', 'description': 'Contracture of Scar Surface Area 1 year post grafting: The surface area of the skin graft cm\\^2 at about one year after skin grafting will be compared to the size of the original skin graft at about one week after surgery.'}], 'secondaryOutcomes': [{'measure': 'Scar Roughness', 'timeFrame': '90 days post-grafting', 'description': 'Scar Roughness at 9 weeks and 12 weeks post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis. A three-dimensional analysis of the molds will allow for measure of average roughness. The machine used will provide a digital read out which will then be averaged to obtain a mean value. This will allow for comparison between treated and control grafts at 90 days and one year.'}, {'measure': 'Scar Roughness', 'timeFrame': '1 year post-grafting', 'description': 'Scar Roughness 10-12 months post grafting: will be quantified using a mold/casting technique using Aquasil Ultra XLV dental impression material followed by mold imaging and quantitative analysis. A three-dimensional analysis of the molds will allow for measure of average roughness. The machine used will provide a digital read out that will then be averaged to obtain a mean value. This will allow for comparison between treated and control grafts at 90 days and one year.'}, {'measure': 'Biomechanics Stiffness', 'timeFrame': '90 days post-grafting', 'description': "Biomechanics Stiffness 90 days post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value."}, {'measure': 'Biomechanics Stiffness', 'timeFrame': '1 year post-grafting', 'description': "Biomechanics Stiffness 10-12 months post grafting: The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value."}, {'measure': 'Biomechanics Elasticity', 'timeFrame': '90 days post-grafting', 'description': "Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer. The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value."}, {'measure': 'Biomechanics Elasticity', 'timeFrame': '1 year post-grafting', 'description': "Elasticity will be quantified using a BTC-2000, a high resolution Target Laser and negative pressure transducer. The BTC-2000 device uses a laser to measure skin deflection as negative atmospheric pressure is applied and this allows for quantification of the skin's mechanical properties (e.g. elasticity and stiffness). The device will provide a digital readout that will be averaged to obtain a mean value."}, {'measure': 'Erythema Index', 'timeFrame': '90 days post-grafting', 'description': 'Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.'}, {'measure': 'Erythema Index', 'timeFrame': '1 year post-grafting', 'description': 'Erythema will be measured using a Mexameter that will accurately measure even small changes in erythema levels, then provide a digital read out from which an average mean can be obtained. The erythema levels are measured on a scale ranging from 0 to around 999. This index reflects the redness of the skin, which can be an indicator of various skin conditions or reactions. Higher index indicates a scar that is more red.'}, {'measure': 'Vancouver Scar Scale (VSS)', 'timeFrame': '90 days post-grafting', 'description': 'Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, \\<2mm=1, 2-5mm=2, \\>5mm=3; Lowest possible score= 0 and Highest Score possible = 13. Higher results denotes worse outcomes.'}, {'measure': 'Vancouver Scar Scale (VSS)', 'timeFrame': '1 year post-grafting', 'description': 'Scar-rating scale that objectively evaluates scar properties to include the following: Vascularity: Normal = 0, Pink=1, Red = 2, Purple = 3; Pigmentation: Normal= 0, Hypopigmentation= 1, Hyperpigmentation= 2; Pliability: Normal= 0, Supple =1, Yielding= 2, Firm= 3, Ropes= 4, Contracture= 5; Height: Flat= 0, \\<2mm=1, 2-5mm=2, \\>5mm=3; Lowest possible score= 0 and Highest Score possible = 13. Higher results denotes worse outcomes.'}, {'measure': 'Patient and Observer Scar Assessment Scale (POSAS)--Patient', 'timeFrame': '90 days post-grafting', 'description': 'Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.'}, {'measure': 'Patient and Observer Scar Assessment Scale (POSAS)--Observer', 'timeFrame': '90 days post-grafting', 'description': 'Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.'}, {'measure': 'Patient and Observer Scar Assessment Scale (POSAS)--Patient', 'timeFrame': '1 year post-grafting', 'description': 'Subjective scar scale for the patient that measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of seven questions with total score ranging from 7-70. The higher the score the worse the scar.'}, {'measure': 'Patient and Observer Scar Assessment Scale (POSAS)--Observer', 'timeFrame': '1 year post-grafting', 'description': 'Subjective scar scale for the observer measures perception of scar height, pliability, pigmentation, vascularization, and relief. Survey consists of six questions. Total score range 6-60. The higher the score the worse the scar.'}, {'measure': 'Patient-Reported Satisfaction', 'timeFrame': '90 days post-grafting', 'description': 'Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.'}, {'measure': 'Patient-Reported Satisfaction', 'timeFrame': '1 year post-grafting', 'description': 'Subjective measurement of patient satisfaction of outcome based on a 0-10 Likert scale with 10 being the best outcome.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fractional laser', 'Ablative Laser', 'Carbon Dioxide Laser'], 'conditions': ['Burn Scar', 'Skin Graft Scar']}, 'descriptionModule': {'briefSummary': 'Doctors and patients refer to all areas of skin changes from burn injury as burn scars. However, different areas of scars from burns can be treated differently. The burn scars that come from skin grafting surgery might be improved with laser treatment. The purpose of this study is to see if treating burn skin graft scars with a laser could make it better.\n\nFractional Ablative Laser has been approved by the US Food and Drug Administration (FDA), but it has not been approved for use in the early stages of scar maturation and is considered investigational for this study.', 'detailedDescription': 'This pilot study is being conducted to establish safety, however the study team will make multiple measures to measure for efficacy as well. The study team hypothesizes that human split-thickness skin grafts will safely respond similar to the porcine model when treated with the Fractional Carbon Dioxide (FxCO2) laser and have significantly less secondary contracture than control sites. The great majority of laser studies have addressed treatment of established scars. Ideally, treatment modalities could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the time to maximum recovery, and mitigate scar formation. The current study will address the impact on treatment of skin graft applied in the treatment of acute burn wounds. Preliminary work completed by our team has confirmed that the red Duroc porcine model is a good model of hypertrophic scar formation in humans, and early use of the FxCO2 on split-thickness skin grafts decreased secondary contracture. Further, the study team has identified a period of 19 weeks between the time custom-made compression garments are ordered and actually applied with benefit to the patient. The study team has identified a "therapeutic donut hole" in which they have no efficacious alternative to offer until about 19 weeks. In these patients who had larger burn returning to the OR for additional procedures, the study team was able to offer FxCO2 treatment as a "salvage" therapy. With this, the study team has demonstrated safety for the skin graft and anecdotal efficacy. The study team proposes a pilot study to prospectively demonstrate safety in a controlled study and attempt to establish efficacy of early (post grafting day 7-10) FxCO2 laser treatment of split-thickness skin graft applied in the treatment of burn injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are to undergo skin grafting procedures for acute treatment of thermal burns.\n* Patients with grafts placed over at least 100cm\\^2\n\nExclusion Criteria:\n\n* Patients who have are not scheduled to undergo skin grafting procedures\n* Patients who have grafts placed under 100cm\\^2'}, 'identificationModule': {'nctId': 'NCT04176705', 'briefTitle': 'Fractional Ablative Laser Treatment for Skin Grafts', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns', 'orgStudyIdInfo': {'id': 'IRB00058363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser', 'description': 'Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser.', 'interventionNames': ['Drug: Lidocaine Cream', 'Drug: Triamcinolone Acetonide Cream', 'Device: Fractional Ablative Laser']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No laser', 'description': 'Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser.', 'interventionNames': ['Drug: Lidocaine Cream', 'Drug: Triamcinolone Acetonide Cream']}], 'interventions': [{'name': 'Lidocaine Cream', 'type': 'DRUG', 'description': 'Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.', 'armGroupLabels': ['Laser', 'No laser']}, {'name': 'Triamcinolone Acetonide Cream', 'type': 'DRUG', 'description': 'Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.', 'armGroupLabels': ['Laser', 'No laser']}, {'name': 'Fractional Ablative Laser', 'type': 'DEVICE', 'description': 'Applied to only site that is randomized to laser intervention', 'armGroupLabels': ['Laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Health', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}], 'overallOfficials': [{'name': 'John Bailey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data will become available within 6 months of data completion.', 'ipdSharing': 'YES', 'description': 'We will plan to share individual participant data with other researchers. We welcome critical examination of the protocol, statistical analysis of recorded data, informed consent form, and clinical study report. We are happy to share de-identified data (original photo files, tracings, and recorded measures of skin quality) and responses to questionnaires.', 'accessCriteria': 'Research groups with authors who have at least one related publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}