Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-04-18 @ 8:14 AM
Study NCT ID:
NCT01770860
Status:
COMPLETED
Last Update Posted:
2014-08-04
First Post:
2013-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Test of Different Kinds of Bandages on Healing of Wounds
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '973-385-7984', 'title': 'Associate Director, Clinical Research', 'organization': 'Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '30 days and beyond for serious adverse events if assessed as possibly treatment related. Visits 2-15 and beyond if needed for adverse events.', 'description': 'The safety population was 46. One subject withdrew from the study, before randomization or receving treatment, due to a serious adverse event.\n\nAdverse events were collected for all five interventions simultaneously without attributing causal relationship to a particular intervention.', 'eventGroups': [{'id': 'EG000', 'title': '4 Commercially-available Bandage and 1 Control', 'description': "Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.", 'otherNumAtRisk': 46, 'otherNumAffected': 11, 'seriousNumAtRisk': 46, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Excoriation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper Respiratory Tract Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tooth Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza Like Illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Healing (Days)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '45', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '12.95', 'upperLimit': '13.14'}, {'value': 'NA', 'comment': 'Due to the censoring status of the data, the median time to healing could not be estimated', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '13.1', 'groupId': 'OG002', 'lowerLimit': '13.05', 'upperLimit': '13.15'}, {'value': 'NA', 'comment': 'Due to the censoring status of the data, the median time to healing could not be estimated', 'groupId': 'OG003', 'lowerLimit': '10.90', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to the censoring status of the data, the median time to healing could not be estimated', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'within 14 days', 'description': 'Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.', 'unitOfMeasure': 'days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. Forty six subjects were enrolled but one withdrew before randomization.'}, {'type': 'SECONDARY', 'title': 'Forced Rank Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '1.48', 'spread': '0.58', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '3.04', 'spread': '0.90', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '1.88'}, {'value': '2.44', 'spread': '0.95', 'groupId': 'OG002', 'lowerLimit': '0.65', 'upperLimit': '1.28'}, {'value': '3.77', 'spread': '1.01', 'groupId': 'OG003', 'lowerLimit': '1.97', 'upperLimit': '2.61'}, {'value': '3.29', 'spread': '0.95', 'groupId': 'OG004', 'lowerLimit': '1.50', 'upperLimit': '2.13'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'The p-values presented were for each of the bandage groups compared to no treatment group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from mixed model with Treatment (trt) as fix effect, and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 14 days', 'description': 'The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.'}, {'type': 'SECONDARY', 'title': 'Erythema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '0.64', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '0.90', 'spread': '0.42', 'groupId': 'OG001', 'lowerLimit': '-1.02', 'upperLimit': '-0.67'}, {'value': '0.90', 'spread': '0.49', 'groupId': 'OG002', 'lowerLimit': '-1.01', 'upperLimit': '-0.66'}, {'value': '0.97', 'spread': '0.48', 'groupId': 'OG003', 'lowerLimit': '-0.94', 'upperLimit': '-0.59'}, {'value': '0.88', 'spread': '0.43', 'groupId': 'OG004', 'lowerLimit': '-1.03', 'upperLimit': '-0.68'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'The p-values presented were for each of the bandage groups compared to no treatment group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 14 days', 'description': 'Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.'}, {'type': 'SECONDARY', 'title': 'Edema', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '1.44', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '0.57', 'spread': '0.38', 'groupId': 'OG001'}, {'value': '0.69', 'spread': '0.43', 'groupId': 'OG002'}, {'value': '0.56', 'spread': '0.42', 'groupId': 'OG003'}, {'value': '0.64', 'spread': '0.39', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'The p-values presented were for each of the bandage groups compared to no treatment group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 14 days', 'description': 'Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.'}, {'type': 'SECONDARY', 'title': 'Maceration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '4.37', 'spread': '9.15', 'groupId': 'OG000'}, {'value': '70.98', 'spread': '22.12', 'groupId': 'OG001'}, {'value': '65.21', 'spread': '23.43', 'groupId': 'OG002'}, {'value': '39.34', 'spread': '31.88', 'groupId': 'OG003'}, {'value': '63.99', 'spread': '26.64', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'pValueComment': 'The p-values presented were for each of the bandage groups compared to no treatment group.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 14 days', 'description': 'Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.', 'unitOfMeasure': 'percentage of maceration', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '5.24', 'spread': '12.39', 'groupId': 'OG000'}, {'value': '4.55', 'spread': '10.13', 'groupId': 'OG001'}, {'value': '2.45', 'spread': '6.38', 'groupId': 'OG002'}, {'value': '3.85', 'spread': '7.87', 'groupId': 'OG003'}, {'value': '2.45', 'spread': '5.69', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.0476', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'P-value is from mixed model with treatment (trt) as fix effect, and subject as random effect', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'within 14 days', 'description': 'Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.', 'unitOfMeasure': 'percentage of pain', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Itch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '21.33', 'spread': '28.24', 'groupId': 'OG000'}, {'value': '26.22', 'spread': '29.46', 'groupId': 'OG001'}, {'value': '16.43', 'spread': '21.73', 'groupId': 'OG002'}, {'value': '25.87', 'spread': '26.24', 'groupId': 'OG003'}, {'value': '20.10', 'spread': '22.15', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'within 14 days', 'description': 'Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.', 'unitOfMeasure': 'percentage of itching', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.'}, {'type': 'SECONDARY', 'title': 'Subjective Assessment of Wound Healing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Bandage QuiltVent™ Sheer Strips (With Pad Removed)', 'description': 'No treatment'}, {'id': 'OG001', 'title': 'Bandage QuiltVent™ Sheer Strips'}, {'id': 'OG002', 'title': 'Bandage QuiltVent™ Flexible Fabric'}, {'id': 'OG003', 'title': 'Bandage QuiltVent™ Tough Strips Waterproof'}, {'id': 'OG004', 'title': 'Bandage Dora the Explorer™'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}, {'value': '26', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 14 days', 'description': 'Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Intent-to-Treat (ITT) population is defined as all subjects who received study bandages. One randomized subject withdrew from the study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '4 Commercially-available Bandage and 1 Control', 'description': "Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Forty-six subjects were enrolled but one subject withdrew before randomization.', 'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'Randomization', 'achievements': [{'comment': 'One participant withdrew before randomization', 'groupId': 'FG000', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Administrative decision made by the PI', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'One additional subject was enrolled but withdrew before randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '4 Commercially-available Bandage and 1 Control', 'description': "Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.4', 'spread': '7.47', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '24', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '21', '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': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '45', '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'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '41', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fitzpatrick Skin Classification', 'classes': [{'title': 'Fitzpatrick Skin Classification - II', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'Fitzpatrick Skin Classification - III', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': "The Fitzpatrick skin classification is based on the skin's unprotected response to the first 30-45 minutes of sun exposure after a winter season without sun exposure. The classification is on a scale from I to VI where I = always burns easily; never tans and VI =Never burns; deeply pigmented.", 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-31', 'studyFirstSubmitDate': '2013-01-16', 'resultsFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2013-01-16', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-31', 'studyFirstPostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Healing (Days)', 'timeFrame': 'within 14 days', 'description': 'Wound epithelialization will be recorded daily for each wound (until healed) by the doctor on a scale of 0-5, where 0= No presence of epithelialization (no sign of healing), a bandage is necessary and 5=Wound is 100% epithelialized (healed), no bandage necessary. The median time to healing will be estimated from the survival curves using the Kaplan-Meier method for each test product. Time to healing is defined as the time from wounding to 12:00 pm of the day the wound is 100% epithelialized (receives a score of 5). If the wound is not 100% epithelialized on Day 14 or on the last day of visit, Time to healing will be considered as censored.'}], 'secondaryOutcomes': [{'measure': 'Forced Rank Score', 'timeFrame': 'within 14 days', 'description': 'The wound evaluator will rank the overall appearance of all five wounds in relation to each other on a daily basis until all five are healed on a scale of 1 to 5, where 1= Worst and 5=Best. The forced Rank was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.'}, {'measure': 'Erythema', 'timeFrame': 'within 14 days', 'description': 'Until healed, erythema (redness) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Erythema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed here using a mixed model.'}, {'measure': 'Edema', 'timeFrame': 'within 14 days', 'description': 'Until healed, edema (swelling) of each wound bed and surrounding skin will be scored daily on a scale of 0-10, where 0=None and 10=Most severe. Mean Edema was evaluated at each visit. The mean score derived as total score divided by visit number 13 was analyzed using a mixed model.'}, {'measure': 'Maceration', 'timeFrame': 'within 14 days', 'description': 'Until healed, maceration (a slight whitening of the skin around the wound compared to the surrounding unbandaged area) will be scored as P=Present or A=Absent. Percentage of maceration was derived as the maceration presence times over study period divided by visit number 13.'}, {'measure': 'Subjective Assessment of Pain', 'timeFrame': 'within 14 days', 'description': 'Until healed, pain assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of pain was derived as the pain presence times over study period divided by visit number 13.'}, {'measure': 'Subjective Assessment of Itch', 'timeFrame': 'within 14 days', 'description': 'Until healed, itch assessments by the participant will be recorded daily for each wound site as either Present (P) or Absent (A). Percentage of itch was derived as the itch presence times over study period divided by visit number 13.'}, {'measure': 'Subjective Assessment of Wound Healing', 'timeFrame': 'within 14 days', 'description': 'Until healed, subjects will be shown photographs of each wound they have not previously classified as healed at each daily visit, and asked to determine if the wound is healed. Yes or No responses will be recorded, along with text entries of the reasons for the response. This outcome measure reports the number of subjects who report that the wound has healed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adhesive Bandages', 'Dermabrasion Wounds'], 'conditions': ['Wound Healing']}, 'descriptionModule': {'briefSummary': 'This two-week study will compare the healing of minor wounds when no bandage is applied against four different types of bandages.\n\nThe study investigators will make five small wounds similar to scrapes (about a half-inch square) on the back of subjects who qualify to participate in the trial and have given informed consent. Four of the wounds will be covered by different bandages and one will be left uncovered. Participants will visit the clinic every day for 2 weeks or until all the wounds are healed (whichever comes first). At the clinic, the bandages will be removed, the doctor will score the wounds, a picture will be taken of the wounds and new bandages will be applied.\n\nIt is expected that some pain and itching will be experienced, because they are part of the normal wound healing process. Subjects will be asked about adverse events at each visit and will have the opportunity to discuss issues or concerns with the investigator or the doctor during the course of the trial. It is expected that the wounds will be completely healed within 14 days, but if not, the participant will need to return to the clinic for follow-up treatment until the wounds are completely healed.\n\nWe will see if the different bandages help with the healing of the wounds during the study.', 'detailedDescription': "This study is evaluating the performance of various bandages on facilitating the healing of induced dermabrasion wounds. To qualify for this study, subjects must meet the inclusion/exclusion criteria within the protocol-specified parameters at both the screening and baseline visits. Once a subject is qualified, five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages and one wound will be left open to the air to serve as a no treatment control. Treatments and control will be randomized to application site. During this 14-day clinical study, subjects will return to the site for daily evaluations; study bandages will also be replaced daily by study personnel. Adverse events will be observed and collected by querying each subject at each visit, and during any follow-up period."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects must be able to read and understand English enough to understand the nature, risk and relevance of the study, read and sign the informed consent document, and follow study instructions\n* After being completely informed about the study and being given a chance to have all questions answered, the subject has signed an informed consent document agreeing to:\n* comply with lifestyle instructions, including: limiting bandage exposure to water or sunlight, the use of lotions, creams, cosmetics or sunscreens during the study, to allow at least 2 hours between showers and scheduled visits, and the use of contraception\n* return to the clinical site for follow-up visits if the wounds are not healed by Day 14\n* Subject is determined to be an appropriate participant according to protocol-defined conditions, including among other things, Body Weight and Fitzpatrick Skin Type between I (Always burns easily, never tans) and III (Burns moderately, tans gradually)\n* In the opinion of the Investigator, participation in the trial will not compromise the subject's safety or the interpretation of study results\n\nExclusion Criteria:\n\n* Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator\n* Known allergies or hypersensitivity to LATEX, anesthetics, adhesive bandages, wound treatment products or any component present in the test bandages\n* Current participation in any other clinical trial or past participation in other clinical trials described in the protocol\n* Body mass index (BMI) above 35, and/or Fitzpatrick Skin Type above III\n* Pregnant, nursing or planning a pregnancy"}, 'identificationModule': {'nctId': 'NCT01770860', 'briefTitle': 'A Test of Different Kinds of Bandages on Healing of Wounds', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'An Assessment of QuiltVent™ Pad Technology on the Healing of Induced Dermabrasion Wounds', 'orgStudyIdInfo': {'id': 'ABDWDP0005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '6660', 'description': "Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.", 'interventionNames': ['Device: 6660']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4314', 'description': "Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.", 'interventionNames': ['Device: 4314']}, {'type': 'ACTIVE_COMPARATOR', 'label': '8336', 'description': "Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.", 'interventionNames': ['Device: 8336']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4840', 'description': "Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.", 'interventionNames': ['Device: 4840']}, {'type': 'NO_INTERVENTION', 'label': '0000', 'description': "Device: 0000\n\nAt each daily visit, designated study personnel will cut out the center pad of the bandage and apply only the adhesive tabs around the assigned wound site.\n\nOther Names:\n\n* Sheer Strips\n* BAND-AID® with QuiltVent™ Pad Technology\n\nFive dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site."}], 'interventions': [{'name': '6660', 'type': 'DEVICE', 'otherNames': ['Sheer Strips', 'BAND-AID® with QuiltVent™ Pad Technology'], 'description': 'At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.', 'armGroupLabels': ['6660']}, {'name': '4314', 'type': 'DEVICE', 'otherNames': ['Flexible Fabric', 'BAND-AID® with QuiltVent™ Pad Technology'], 'description': 'At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.', 'armGroupLabels': ['4314']}, {'name': '8336', 'type': 'DEVICE', 'otherNames': ['Tough Strips® Waterproof', 'BAND-AID® with QuiltVent™ Pad Technology'], 'description': 'At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.', 'armGroupLabels': ['8336']}, {'name': '4840', 'type': 'DEVICE', 'otherNames': ['Flat Pad', 'BAND-AID® Dora the Explorer™'], 'description': 'At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.', 'armGroupLabels': ['4840']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33710', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Hill Top Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}], 'overallOfficials': [{'name': 'Clare Kendall', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}