Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2026-01-02 @ 2:02 AM
Study NCT ID:
NCT00943150
Status:
COMPLETED
Last Update Posted:
2013-01-01
First Post:
2009-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000084462', 'term': 'Hyperthermia'}], 'ancestors': [{'id': 'D001832', 'term': 'Body Temperature Changes'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018882', 'term': 'Heat Stress Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D004564', 'term': 'Electrocoagulation'}, {'id': 'D004598', 'term': 'Electrosurgery'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D002425', 'term': 'Cautery'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'robert.e.swain@medtronic.com', 'phone': '(+1-603) 294-5428', 'title': 'Robert Swain, PhD', 'organization': 'Medtronic Surgical Technologies'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Extended drainage period', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acute Thermal Injury Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.'}, {'id': 'OG001', 'title': 'Electrocautery', 'description': 'The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.'}], 'classes': [{'categories': [{'measurements': [{'value': '195', 'spread': '127', 'groupId': 'OG000'}, {'value': '763', 'spread': '208', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Immediately postoperative', 'description': 'Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.\n\nAcute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation.', 'unitOfMeasure': 'micrometers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Inflammatory Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.'}, {'id': 'OG001', 'title': 'Electrosurgery', 'description': 'The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.'}, {'id': 'OG002', 'title': 'Scalpel', 'description': 'The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.'}], 'classes': [{'title': 'CD3+ 0 weeks', 'categories': [{'measurements': [{'value': '93', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG000'}, {'value': '120', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG001'}, {'value': '138', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG002'}]}]}, {'title': 'CD3+ 3 weeks', 'categories': [{'measurements': [{'value': '207', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG000'}, {'value': '239', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG001'}, {'value': '171', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG002'}]}]}, {'title': 'CD3+ 6 weeks', 'categories': [{'measurements': [{'value': '216', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG000'}, {'value': '223', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG001'}, {'value': '196', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG002'}]}]}, {'title': 'CD68+ 0 weeks', 'categories': [{'measurements': [{'value': '71', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG000'}, {'value': '75', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG001'}, {'value': '87', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG002'}]}]}, {'title': 'CD68+ 3 weeks', 'categories': [{'measurements': [{'value': '201', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG000'}, {'value': '263', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG001'}, {'value': '173', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG002'}]}]}, {'title': 'CD68+ 6 weeks', 'categories': [{'measurements': [{'value': '232', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG000'}, {'value': '185', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG001'}, {'value': '202', 'spread': 'NA', 'comment': 'Study was conducted by PEAK Surgical before acquisition by Medtronic. The standard deviations for these outcome measures were not retrievable.', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'CD3+ at 0 weeks', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'CD3+ at 3 weeks', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.71', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'CD3+ at 6 weeks', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.67', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'CD68+ at 0 weeks', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'CD68+ at 3 weeks', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciPctValue': '95', 'groupDescription': 'CD68+ at 6 weeks', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0, 3, and 6 weeks', 'description': 'Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.', 'unitOfMeasure': 'cells per square millimeter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Drainage Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '654.89', 'spread': '217.74', 'groupId': 'OG000'}, {'value': '887.70', 'spread': '325.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1128', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Exact Wilcoxon rank-sum test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '0 to 10 days postoperatively', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was removed from the analysis of secondary variables owing to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Change in Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.68', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '-1.62', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0898', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Exact Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative', 'description': 'The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was removed from the analysis of secondary variables owing to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Narcotic Consumption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}], 'classes': [{'title': 'Intraoperative', 'categories': [{'measurements': [{'value': '3.82', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '4.92', 'spread': '1.72', 'groupId': 'OG001'}]}]}, {'title': 'Postoperative (0 to 10 days)', 'categories': [{'measurements': [{'value': '2.39', 'spread': '2.26', 'groupId': 'OG000'}, {'value': '3.33', 'spread': '2.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0760', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Intraoperative narcotic use comparison', 'statisticalMethod': 'Exact Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.5900', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'Postoperative narcotic use comparison', 'statisticalMethod': 'Exact Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative and postoperative (0 to 10 days)', 'description': 'Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.', 'unitOfMeasure': 'Fentanyl microgram units/g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was removed from the analysis of secondary variables owing to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.15', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '3.30', 'spread': '2.72', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4589', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Exact Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative (0 to 10 days)', 'description': "Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was removed from the analysis of secondary variables owing to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Activity Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '452.78', 'spread': '139.57', 'groupId': 'OG000'}, {'value': '347.00', 'spread': '165.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.999', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Exact Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative (0 to 10 days)', 'description': 'Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was removed from the analysis of secondary variables owing to a protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Diet Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.'}, {'id': 'OG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}], 'classes': [{'categories': [{'measurements': [{'value': '701.11', 'spread': '160.97', 'groupId': 'OG000'}, {'value': '470.50', 'spread': '243.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0412', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Exact Wilcoxon test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Postoperative (0 to 10 days)', 'description': 'Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject was removed from the analysis of secondary variables owing to a protocol deviation.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade for the abdominoplasty procedure.'}, {'id': 'FG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.'}, {'id': 'BG001', 'title': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.11', 'spread': '9.41', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '56'}, {'value': '44.40', 'spread': '10.72', 'groupId': 'BG001', 'lowerLimit': '28', 'upperLimit': '58'}, {'value': '43.26', 'groupId': 'BG002', 'lowerLimit': '28', 'upperLimit': '58'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2009-07-20', 'resultsFirstSubmitDate': '2012-11-29', 'studyFirstSubmitQcDate': '2009-07-21', 'lastUpdatePostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-11-29', 'studyFirstPostDateStruct': {'date': '2009-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Thermal Injury Depth', 'timeFrame': 'Immediately postoperative', 'description': 'Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.\n\nAcute thermal injury depth was assessed by incising the resected area during the abdominoplasty operation.'}, {'measure': 'Inflammatory Cell Count', 'timeFrame': '0, 3, and 6 weeks', 'description': 'Histological samples were created by first incising the area to be resected with all 3 modalities (PEAK PlasmaBlade, electrocautery, and scalpel) at 6 and 3 weeks before the operation. Then, the incised tissue was resected during the abdominoplasty and was assessed by analyzing incisions created in the resected area for histological measures.'}], 'secondaryOutcomes': [{'measure': 'Total Drainage Output', 'timeFrame': '0 to 10 days postoperatively'}, {'measure': 'Change in Hemoglobin', 'timeFrame': 'Intraoperative', 'description': 'The outcome measure is reported as change in hemoglobin, not the hemoglobin value itself.'}, {'measure': 'Narcotic Consumption', 'timeFrame': 'Intraoperative and postoperative (0 to 10 days)', 'description': 'Narcotic medications were coded to Fentanyl microgram equivalent units per kilogram.'}, {'measure': 'Postoperative Pain Levels', 'timeFrame': 'Postoperative (0 to 10 days)', 'description': "Wong-Baker FACES Visual Analog Scale, 0 (no hurt) to 10 (hurts worst). The results represent the mean of each subject's mean pain scores over 10 days."}, {'measure': 'Activity Level', 'timeFrame': 'Postoperative (0 to 10 days)', 'description': 'Sum of activity over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their activity level by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.'}, {'measure': 'Diet Volume', 'timeFrame': 'Postoperative (0 to 10 days)', 'description': 'Sum of diet volume (i.e., how much food the subject ate) over 10 days postoperatively using a 0 (0% of normal) to 100 (100% of normal) visual analog scale. Subjects circled a number representing their diet volume by tens (e.g., 10% of normal, 20% of normal). Subjects completed the scale daily through day 10. The results represent the mean cumulative value per patient.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Abdominoplasty', 'PlasmaBlade', 'Electrosurgery', 'PEAK Surgical', 'Medtronic Advanced Energy', 'Medtronic'], 'conditions': ['Elastosis']}, 'referencesModule': {'references': [{'pmid': '21701326', 'type': 'DERIVED', 'citation': 'Ruidiaz ME, Messmer D, Atmodjo DY, Vose JG, Huang EJ, Kummel AC, Rosenberg HL, Gurtner GC. Comparative healing of human cutaneous surgical incisions created by the PEAK PlasmaBlade, conventional electrosurgery, and a standard scalpel. Plast Reconstr Surg. 2011 Jul;128(1):104-111. doi: 10.1097/PRS.0b013e31821741ed.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to evaluate healing of incisions made with the PEAK PlasmaBlade 4.0 compared to scalpel and traditional electrosurgery (Bovie); to monitor and record key post-operative metrics following abdominoplasty with the PEAK PlasmaBlade 4.0 versus current standard of care (SOC); and to evaluate performance metrics of the PEAK PlasmaBlade 4.0 during abdominoplasty.', 'detailedDescription': 'Abdominoplasty is a cosmetic surgical procedure performed to correct abdominal elastosis with skin and fat redundancy. During the procedure, a scalpel and traditional electrosurgical device are used to cut away this excess skin and fat from the abdomen and the underlying muscles are tightened together with sutures.\n\nThe PEAK PlasmaBlade™ uses pulsed radiofrequency (RF) energy to enable precision cutting and coagulating at the point of application, without the thermal damage to surrounding tissues that is normally seen with traditional electrosurgery. The PlasmaBlade has received FDA clearance for use in plastic, general, and ear, nose, and throat (ENT) surgery, and has demonstrated significantly reduced serous drainage in tissue reduction surgeries, like abdominoplasty.\n\nA total of twenty (20) human subjects were recruited from the local community against standardized inclusion/exclusion criteria. Once enrolled, each patient underwent placement of three sets of full-thickness comparison incisions in their abdominal skin with a standard scalpel, PlasmaBlade, and traditional electrosurgery at six (6) and three (3) weeks prior to abdominoplasty, and on the day of surgery under general anesthesia. Subjects were then randomized to undergo abdominoplasty with the PlasmaBlade or the SOC (scalpel and traditional electrosurgery). Following abdominoplasty, harvested healed incisions were submitted for histological analysis and burst strength testing and additional data were recorded in the 10 day post-operative period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 25 and 60 years old\n2. Physically healthy, stable weight, non-smoker\n3. Protruding abdomen, excess fat and skin and/or weak abdominal muscles qualifying for abdominoplasty.\n4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure.\n5. Subject must be willing and able to comply with specified follow-up evaluations.\n6. Female subjects must either be no longer capable of reproduction or taking acceptable measures to prevent pregnancy during the study, and have a negative pregnancy test prior to participation in the study.\n\nExclusion Criteria:\n\n1. Age younger than 25 or greater than 60 years old\n2. Anticoagulation therapy which cannot be discontinued\n3. Smoking (any kind)\n4. Diabetes (any type)\n5. Infection (local or systemic)\n6. Cognitive impairment or mental illness\n7. Severe cardiopulmonary deficiencies\n8. Known coagulopathy\n9. Immunocompromised\n10. Kidney disease (any type)\n11. Subjects who are pregnant or lactating\n12. Currently taking any medication known to affect healing\n13. Subjects who are status-post gastric banding or gastric bypass\n14. Reproductive age females who will not take acceptable measures to prevent pregnancy during the study.\n15. Recent history of abdominal surgery or prior abdominoplasty.\n16. Subjects who are known to be HIV or Hepatitis (any) positive\n17. Currently enrolled in another investigational device or drug trial\n18. Unable to follow instructions or complete follow-up'}, 'identificationModule': {'nctId': 'NCT00943150', 'acronym': 'PRECISE', 'briefTitle': 'PEAK PlasmaBlade™ vs. Traditional Electrosurgery in Abdominoplasty', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic Surgical Technologies'}, 'officialTitle': 'A Prospective, Randomized, Controlled Two-arm Superiority Study to Evaluate Use of the PEAK PlasmaBlade™ 4.0 in Abdominoplasty', 'orgStudyIdInfo': {'id': 'PEAK VP-00055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEAK PlasmaBlade', 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.', 'interventionNames': ['Device: PEAK PlasmaBlade']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care (SOC)', 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.', 'interventionNames': ['Procedure: Standard of Care (SOC)']}], 'interventions': [{'name': 'PEAK PlasmaBlade', 'type': 'DEVICE', 'otherNames': ['PlasmaBlade'], 'description': 'The PEAK PlasmaBlade will be used for the abdominoplasty procedure.', 'armGroupLabels': ['PEAK PlasmaBlade']}, {'name': 'Standard of Care (SOC)', 'type': 'PROCEDURE', 'otherNames': ['Bovie', 'electrocautery', 'electrosurgery'], 'description': 'The scalpel and electrocautery will be used for the abdominoplasty procedure.', 'armGroupLabels': ['Standard of Care (SOC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'El Camino Surgery Center', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}], 'overallOfficials': [{'name': 'Howard L Rosenberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'El Camino Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic Surgical Technologies', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}