Ignite Creation Date:
2025-12-26 @ 11:09 AM
Ignite Modification Date:
2026-02-24 @ 5:02 PM
Study NCT ID:
NCT01977612
Status:
COMPLETED
Last Update Posted:
2017-07-31
First Post:
2013-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Clinical Trial of Skin Closure With Staples Versus Suture
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kurokil@wustl.edu', 'phone': '314-362-2368', 'title': 'Lindsay Kuroki, M.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.', 'otherNumAtRisk': 84, 'otherNumAffected': 0, 'seriousNumAtRisk': 84, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures', 'otherNumAtRisk': 79, 'otherNumAffected': 0, 'seriousNumAtRisk': 79, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'OG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-8 weeks post-surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Wound Disruption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'OG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-8 weeks post-surgery', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '-Data on incidence of wound disruption was not collected on 9 patients in the stainless steel staple arm and 9 patients in the 4-0 Monocryl suture arm.'}, {'type': 'SECONDARY', 'title': 'Incidence of Wound Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'OG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-8 weeks post-surgery', 'description': 'Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'OG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'During surgery', 'description': 'Time from skin incision to the end of skin closure', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected from 3 patients in the stainless steel staple arm and 1 patient in the 4-0 Monocryl suture arm'}, {'type': 'SECONDARY', 'title': 'Analog Pain Score on Postoperative Days 3-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'OG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'timeFrame': '3-4 days post-surgery', 'description': 'The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not collected from any patients for this outcome measure'}, {'type': 'SECONDARY', 'title': 'Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'OG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-8 weeks post-operative', 'description': '* Ranges from 0 (worst) to 5 (best)\n* Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '-Data was not collected from 10 patients in the Stainless Steel Staple arm and 9 patients in the 4-0 Monocryl Suture arm'}, {'type': 'SECONDARY', 'title': 'Median Patient Satisfaction Score of Scar Appearance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'OG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'classes': [{'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000', 'lowerLimit': '49', 'upperLimit': '83'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '87'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4-8 weeks post-operative', 'description': 'Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.', 'unitOfMeasure': 'Patient Satisfaction Score', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': '-Data was not collected on 13 patients in the Stainless Steel Staple arm and 12 patients in the 4-0 Monocryl Suture arm'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'FG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '80'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '84'}, {'groupId': 'FG001', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': '173 participants were enrolled to the study but 8 participants had a change in their surgical procedure which deemed them ineligible for study enrollment and were excluded from the study before randomization to the arms.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Stainless Steel Staples', 'description': 'Skin closure using stainless steel staples.'}, {'id': 'BG001', 'title': '4-0 Monofilament Sutures', 'description': 'Skin closure using 4-0 monofilament sutures'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '13.2', 'groupId': 'BG000'}, {'value': '57.1', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '57.4', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', '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': '84', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '163', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body mass index (BMI)', 'classes': [{'title': '30-39.9', 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': '40-49.9', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '50 or greater', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior Abdominal Surgery', 'classes': [{'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tobacco Use', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cardiovascular disease', 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pulmonary disease', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior malignancy', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'American Society of Anesthesiologists (ASA) class', 'classes': [{'title': '1-2', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}, {'title': '3-4', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'ASA 1 - Normal healthy patient ASA 2 - A patient with mild systemic disease ASA 3 - A patient with severe systemic disease that is a constant threat to life ASA 4 - A moribund patient who is not expected to survive without the operation', 'unitOfMeasure': 'Participants'}, {'title': 'Indications for surgery', 'classes': [{'title': 'Uterine cancer', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}, {'title': 'Ovarian/fallopian/peritoneal cancer', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Benign', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Synchronous primary', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-26', 'studyFirstSubmitDate': '2013-04-17', 'resultsFirstSubmitDate': '2017-05-25', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-26', 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-06-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Wound Disruption or Infection (Wound Complications) Occurring Within 4-8 Weeks of the Date of the Primary Surgery.', 'timeFrame': '4-8 weeks post-surgery'}], 'secondaryOutcomes': [{'measure': 'Incidence of Wound Disruption', 'timeFrame': '4-8 weeks post-surgery'}, {'measure': 'Incidence of Wound Infection', 'timeFrame': '4-8 weeks post-surgery', 'description': 'Purulent drainage, cellulitis, abscess, or a wound that requires drainage, debridement or antibiotics associated with a clinical diagnosis of infection.'}, {'measure': 'Operative Time', 'timeFrame': 'During surgery', 'description': 'Time from skin incision to the end of skin closure'}, {'measure': 'Analog Pain Score on Postoperative Days 3-4', 'timeFrame': '3-4 days post-surgery', 'description': 'The highest pain score as recorded by nursing staff at a minimum of every 8 hours between 72-96 hours postoperatively.'}, {'measure': 'Cosmesis Score as Measured by the Stony Brook Scar Evaluation Score', 'timeFrame': '4-8 weeks post-operative', 'description': '* Ranges from 0 (worst) to 5 (best)\n* Sum of width, height, color, hatch, and overall appearance where a better outcome has a value of 5 and a worse outcome has a value of 0'}, {'measure': 'Median Patient Satisfaction Score of Scar Appearance', 'timeFrame': '4-8 weeks post-operative', 'description': 'Patients will be asked to rate the general appearance, location and comfort of the scar. This was collected as a continuous variable. Patients were given a paper survey and asked to please draw a single slash across a provided line indicating how satisfied they were with the appearance of their scar. The beginning of the line was designated "very unsatisfied" or 0% and the end of the line was "very satisfied" or 100%.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Wound infection', 'Wound separation', 'Skin staples', 'Subcuticular suture'], 'conditions': ['Wound Infection', 'Wound Complication']}, 'referencesModule': {'references': [{'pmid': '12603990', 'type': 'BACKGROUND', 'citation': 'Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.'}, {'pmid': '21324517', 'type': 'BACKGROUND', 'citation': 'Nugent EK, Hoff JT, Gao F, Massad LS, Case A, Zighelboim I, Mutch DG, Thaker PH. Wound complications after gynecologic cancer surgery. Gynecol Oncol. 2011 May 1;121(2):347-52. doi: 10.1016/j.ygyno.2011.01.026. Epub 2011 Feb 15.'}, {'pmid': '16796988', 'type': 'BACKGROUND', 'citation': 'Cardosi RJ, Drake J, Holmes S, Tebes SJ, Hoffman MS, Fiorica JV, Roberts WS, Grendys EC Jr. Subcutaneous management of vertical incisions with 3 or more centimeters of subcutaneous fat. Am J Obstet Gynecol. 2006 Aug;195(2):607-14; discussion 614-6. doi: 10.1016/j.ajog.2006.04.013. Epub 2006 Jun 21.'}, {'pmid': '8765253', 'type': 'BACKGROUND', 'citation': 'Gallup DC, Gallup DG, Nolan TE, Smith RP, Messing MF, Kline KL. Use of a subcutaneous closed drainage system and antibiotics in obese gynecologic patients. Am J Obstet Gynecol. 1996 Aug;175(2):358-61; discussion 362. doi: 10.1016/s0002-9378(96)70146-1.'}, {'pmid': '8112641', 'type': 'BACKGROUND', 'citation': 'Soisson AP, Olt G, Soper JT, Berchuck A, Rodriguez G, Clarke-Pearson DL. Prevention of superficial wound separation with subcutaneous retention sutures. Gynecol Oncol. 1993 Dec;51(3):330-4. doi: 10.1006/gyno.1993.1299.'}, {'pmid': '21079110', 'type': 'BACKGROUND', 'citation': 'Anthony T, Murray BW, Sum-Ping JT, Lenkovsky F, Vornik VD, Parker BJ, McFarlin JE, Hartless K, Huerta S. Evaluating an evidence-based bundle for preventing surgical site infection: a randomized trial. Arch Surg. 2011 Mar;146(3):263-9. doi: 10.1001/archsurg.2010.249. Epub 2010 Nov 15.'}, {'pmid': '12066083', 'type': 'BACKGROUND', 'citation': 'Magann EF, Chauhan SP, Rodts-Palenik S, Bufkin L, Martin JN Jr, Morrison JC. Subcutaneous stitch closure versus subcutaneous drain to prevent wound disruption after cesarean delivery: a randomized clinical trial. Am J Obstet Gynecol. 2002 Jun;186(6):1119-23. doi: 10.1067/mob.2002.123823.'}, {'pmid': '15863532', 'type': 'BACKGROUND', 'citation': 'Ramsey PS, White AM, Guinn DA, Lu GC, Ramin SM, Davies JK, Neely CL, Newby C, Fonseca L, Case AS, Kaslow RA, Kirby RS, Rouse DJ, Hauth JC. Subcutaneous tissue reapproximation, alone or in combination with drain, in obese women undergoing cesarean delivery. Obstet Gynecol. 2005 May;105(5 Pt 1):967-73. doi: 10.1097/01.AOG.0000158866.68311.d1.'}, {'pmid': '23262925', 'type': 'BACKGROUND', 'citation': 'Figueroa D, Jauk VC, Szychowski JM, Garner R, Biggio JR, Andrews WW, Hauth J, Tita AT. Surgical staples compared with subcuticular suture for skin closure after cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2013 Jan;121(1):33-8. doi: 10.1097/aog.0b013e31827a072c.'}, {'pmid': '9350017', 'type': 'BACKGROUND', 'citation': 'Frishman GN, Schwartz T, Hogan JW. Closure of Pfannenstiel skin incisions. Staples vs. subcuticular suture. J Reprod Med. 1997 Oct;42(10):627-30.'}, {'pmid': '20417924', 'type': 'BACKGROUND', 'citation': 'Cromi A, Ghezzi F, Gottardi A, Cherubino M, Uccella S, Valdatta L. Cosmetic outcomes of various skin closure methods following cesarean delivery: a randomized trial. Am J Obstet Gynecol. 2010 Jul;203(1):36.e1-8. doi: 10.1016/j.ajog.2010.02.001. Epub 2010 Apr 24.'}, {'pmid': '22910336', 'type': 'BACKGROUND', 'citation': 'de Graaf IM, Oude Rengerink K, Wiersma IC, Donker ME, Mol BW, Pajkrt E. Techniques for wound closure at caesarean section: a randomized clinical trial. Eur J Obstet Gynecol Reprod Biol. 2012 Nov;165(1):47-52. doi: 10.1016/j.ejogrb.2012.07.019. Epub 2012 Aug 19.'}, {'pmid': '19254586', 'type': 'BACKGROUND', 'citation': 'Rousseau JA, Girard K, Turcot-Lemay L, Thomas N. A randomized study comparing skin closure in cesarean sections: staples vs subcuticular sutures. Am J Obstet Gynecol. 2009 Mar;200(3):265.e1-4. doi: 10.1016/j.ajog.2009.01.019.'}, {'pmid': '21195384', 'type': 'BACKGROUND', 'citation': 'Clay FS, Walsh CA, Walsh SR. Staples vs subcuticular sutures for skin closure at cesarean delivery: a metaanalysis of randomized controlled trials. Am J Obstet Gynecol. 2011 May;204(5):378-83. doi: 10.1016/j.ajog.2010.11.018. Epub 2010 Dec 31.'}, {'pmid': '21343772', 'type': 'BACKGROUND', 'citation': 'Tuuli MG, Rampersad RM, Carbone JF, Stamilio D, Macones GA, Odibo AO. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis. Obstet Gynecol. 2011 Mar;117(3):682-690. doi: 10.1097/AOG.0b013e31820ad61e.'}, {'pmid': '23152219', 'type': 'BACKGROUND', 'citation': 'Mackeen AD, Berghella V, Larsen ML. Techniques and materials for skin closure in caesarean section. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD003577. doi: 10.1002/14651858.CD003577.pub3.'}, {'pmid': '15621905', 'type': 'BACKGROUND', 'citation': 'Shetty AA, Kumar VS, Morgan-Hough C, Georgeu GA, James KD, Nicholl JE. Comparing wound complication rates following closure of hip wounds with metallic skin staples or subcuticular vicryl suture: a prospective randomised trial. J Orthop Surg (Hong Kong). 2004 Dec;12(2):191-3. doi: 10.1177/230949900401200210.'}, {'pmid': '2840224', 'type': 'BACKGROUND', 'citation': 'Haymer DS, Marsh JL. Germ line and somatic instability of a white mutation in Drosophila mauritiana due to a transposable genetic element. Dev Genet. 1986;6(4):281-91. doi: 10.1002/dvg.1020060406.'}, {'pmid': '16334959', 'type': 'BACKGROUND', 'citation': 'Fick JL, Novo RE, Kirchhof N. Comparison of gross and histologic tissue responses of skin incisions closed by use of absorbable subcuticular staples, cutaneous metal staples, and polyglactin 910 suture in pigs. Am J Vet Res. 2005 Nov;66(11):1975-84. doi: 10.2460/ajvr.2005.66.1975.'}, {'pmid': '18090752', 'type': 'BACKGROUND', 'citation': 'Singer AJ, Arora B, Dagum A, Valentine S, Hollander JE. Development and validation of a novel scar evaluation scale. Plast Reconstr Surg. 2007 Dec;120(7):1892-1897. doi: 10.1097/01.prs.0000287275.15511.10.'}, {'pmid': '28594761', 'type': 'DERIVED', 'citation': 'Kuroki LM, Mullen MM, Massad LS, Wu N, Liu J, Mutch DG, Powell MA, Hagemann AR, Thaker PH, McCourt CK, Novetsky AP. Wound Complication Rates After Staples or Suture for Midline Vertical Skin Closure in Obese Women: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):91-99. doi: 10.1097/AOG.0000000000002061.'}]}, 'descriptionModule': {'briefSummary': 'Women with gynecologic cancers are often obese and have other risk factors for post-operative wound separation. Data from obstetrics and orthopedic surgery literature have shown a decreased risk of wound separation and complications when the skin is closed with suture as compared to staples. Skin closure with either staples or suture is considered standard of care. Traditionally, most wounds have been closed with staples given their ease of use and quick application. In this randomized study the investigators plan to evaluate and compare the complication rate associated with both standard closures.', 'detailedDescription': 'The investigators propose a randomized controlled trial to evaluate for a difference in wound complication rate between closure with sutures that are placed just below the skin level to hold the skin together and metal staples in obese women (BMI\\>=30) undergoing gynecologic or gynecologic oncology via a midline skin incision for benign or cancer indications under the supervision of one of the full-time faculty members of the Division of Gynecologic Oncology at Washington University School of Medicine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women, \\>=18 and \\<= 85 years of age, undergoing surgery, via a midline laparotomy.\n* Body mass index \\>=30\n* Benign or oncologic indications for surgery.\n* Women of childbearing age will be required to have a negative human chorionic gonadotropin (HCG) test within seven days of surgery.\n* Surgery will be supervised by one of the gynecologic oncology attendings at Washington University School of Medicine.\n* Ability to understand and willingness to sign an IRB approved written informed consent document.\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Pfannenstiel or transverse abdominal incision\n* Concomitant panniculectomy or plastic surgery\n* Women \\<18 years of age\n* History of prior abdominal or pelvic radiation\n* Inability to sign an informed consent form prior to registration on study\n* Inability to understand spoken or written English\n* Prisoner\n* Mental incapacity\n* A history of allergic reactions attributed to either Monocryl suture or stainless steel staples.'}, 'identificationModule': {'nctId': 'NCT01977612', 'briefTitle': 'Randomized Clinical Trial of Skin Closure With Staples Versus Suture', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Randomized Controlled Phase IIB Trial Evaluating Wound Complication Rate After Skin Closure With Staples Versus Subcuticular Suture in Patients With BMI >=30', 'orgStudyIdInfo': {'id': '201304058'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stainless Steel Staples', 'description': 'Skin closure with stainless steel staples', 'interventionNames': ['Device: Stainless steel staples']}, {'type': 'EXPERIMENTAL', 'label': '4-0 monofilament Sutures', 'description': 'Skin closure with 4-0 monofilament sutures', 'interventionNames': ['Device: 4-0 monofilament suture']}], 'interventions': [{'name': '4-0 monofilament suture', 'type': 'DEVICE', 'otherNames': ['4-0 Monocryl suture'], 'description': 'Skin closure using 4-0 monofilament suture', 'armGroupLabels': ['4-0 monofilament Sutures']}, {'name': 'Stainless steel staples', 'type': 'DEVICE', 'description': 'Skin closure using stainless steel staples.', 'armGroupLabels': ['Stainless Steel Staples']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Lindsay Kuroki, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}