Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-04 @ 8:02 PM
Study NCT ID:
NCT01753518
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2012-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dow.margaret@mayo.edu', 'phone': '507-266-8008', 'title': 'Dr. Margaret Dow', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The data are limited by the lack of diversity, and there may be racial or genetic differences in wound healing confounding the results. This trial was not powered for postoperative wound complications.'}}, 'adverseEventsModule': {'timeFrame': 'Post operative complications were collected from December 2012 through June 2014.', 'description': 'Not all subjects returned for their postpartum appointment, so the reporting population is Suture (N=93) and Staples (N=96). Subjects could have experienced more than one category of complications.', 'eventGroups': [{'id': 'EG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.', 'otherNumAtRisk': 93, 'otherNumAffected': 7, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.', 'otherNumAtRisk': 96, 'otherNumAffected': 6, 'seriousNumAtRisk': 96, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Staple expulsion or suture trimming', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Surgical Site Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Superficial Wound Separation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seroma', 'notes': 'A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematoma', 'notes': 'A hematoma is a circumscribed collection of blood, usually clotted, in a tissue or organ, caused by a break in a blood vessel.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 96, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Surgical Time, All Resident Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '68.2'}, {'value': '54.0', 'groupId': 'OG001', 'lowerLimit': '44.9', 'upperLimit': '63.6'}]}]}], 'analyses': [{'pValue': '0.053', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at the time of the procedure (day 1), approximately 1 hour after incision start', 'description': 'Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Total Number of Participants With Postoperative Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.73', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the day of the procedure (Day 1) for 6 weeks', 'description': 'Postoperative complications were assessed by chart review.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of participants analyzed was reduced because some patients did not return for postpartum followup visits.'}, {'type': 'SECONDARY', 'title': 'Participants With Postoperative Complications, by Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'title': 'Staple Expulsion or Suture Trimming', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Surgical Site Infection', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Superficial Wound Separation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Complete Wound Dehiscence', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Seroma', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hematoma', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'No Postoperative Complications', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.25', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison for staple expulsion or suture trimming', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison for Surgical Site Infection', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.21', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison for Superficial Wound Separation', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison for Seroma', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison for Hematoma', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'From the day of the procedure (Day 1) for 6 weeks', 'description': 'Postoperative complications were assessed by chart review.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants could have experienced more than one type of postoperative complication. Note: wound dehiscence is a surgical complication in which a wound ruptures along surgical suture. A seroma is a pocket of clear serous fluid. A hematoma is a localized swelling that is filled with blood caused by a break in the wall of a blood vessel.'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'title': 'Tylenol', 'categories': [{'measurements': [{'value': '12000', 'groupId': 'OG000', 'lowerLimit': '11000', 'upperLimit': '13000'}, {'value': '12000', 'groupId': 'OG001', 'lowerLimit': '9000', 'upperLimit': '13000'}]}]}, {'title': 'Ibuprofen', 'categories': [{'measurements': [{'value': '5400', 'groupId': 'OG000', 'lowerLimit': '3600', 'upperLimit': '6000'}, {'value': '4800', 'groupId': 'OG001', 'lowerLimit': '3600', 'upperLimit': '6000'}]}]}, {'title': 'Toradol', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000', 'lowerLimit': '45', 'upperLimit': '45'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '45', 'upperLimit': '45'}]}]}, {'title': 'Oxycodone', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '100'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '25', 'upperLimit': '100'}]}]}], 'analyses': [{'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for Tylenol use.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.30', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for Ibuprofen use.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for Toradol use.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between the arms for Oxycodone use.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'From day of procedure until end of hospital stay (typical dismissal on day 4)', 'description': 'Post-operative pain was assessed by pain medication use through chart review.', 'unitOfMeasure': 'mg', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'title': 'Patient-controlled analgesia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Alternative oral analgesic', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Single dose IV/IM analgesic', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day of procedure until end of hospital stay (typical dismissal on day 4)', 'description': 'Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'title': 'Appearance of incision: negative', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Appearance of incision: positive', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Would recommend: negative', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Would recommend: positive', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}]}, {'title': 'Willingness (again): negative', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Willingness (again): positive', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'Overall satisfaction: negative', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Overall satisfaction: positive', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.51', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison for negative responses to "Appearance of incision" question.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.098', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison for negative responses to "Would recommend treatment to friends" question.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.57', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison of negative responses to "Willingness to use treatment again" question.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison of negative responses to "Overall satisfaction" question.', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment', 'description': 'Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The reduction in the number of participants analyzed is due to not all participants completing the questionnaire, and all the questions. For appearance of incision, N=58:69. For willingness to use treatment again, N=59:68.'}, {'type': 'SECONDARY', 'title': 'Surgeon Satisfaction (Per Procedure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'title': 'Appearance of incision: negativ', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Appearance of incision: positive', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}]}, {'title': 'Recommend: negative', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Recommend: positive', 'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Willingness to use again: negative', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Willingness to use again: positive', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.85', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for "appearance of incision."', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for "recommend treatment."', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for "willingness to use treatment again."', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Immediately after the procedure (day 1)', 'description': 'Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision?" "How willing are you to recommend this skin closure (whether it was staples or suture) to a patient?" "How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section?" There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with "not at all,\' "not very," and "no opinion" being a negative response, and "somewhat" and "extremely " being a positive response. Categories reported were negative, (including no opinion), and positive.', 'unitOfMeasure': 'Surgeons reporting per category', 'reportingStatus': 'POSTED', 'populationDescription': "A satisfaction survey wasn't completed for all of the procedures (103 per arm), so the reporting population is 91 for the suture arm, and 96 for the staple arm."}, {'type': 'PRIMARY', 'title': 'Skin Closure Time, All Resident Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '103', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '10.5'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Measured at the time of the procedure (day 1), approximately 1 hour after incision start', 'description': 'Measured for all resident education levels (1 to 4 years postgraduate).', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-Treat'}, {'type': 'SECONDARY', 'title': 'Cosmetic Outcome', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'OG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'classes': [{'title': 'Patient: scar painful', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '2'}]}]}, {'title': 'Patient: scar itching', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '3'}]}]}, {'title': 'Patient: scar color is different', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6'}]}]}, {'title': 'Patient: scar stiffness is different', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '8'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '6'}]}]}, {'title': 'Patient: scar thickness is different', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '7.5'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.5'}]}]}, {'title': 'Patient: scar more irregular', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '6'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '5.5'}]}]}, {'title': 'Patient: scar overall opinion', 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '6'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '5'}]}]}, {'title': 'Observer: vascularity', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Observer: pigmentation', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Observer: thickness', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Observer: relief', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Observer: pliability', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Observer: surface area', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}, {'title': 'Observer: overall opinion', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for patient: scar painful.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for patient: scar itching.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.034', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for patient: scar color is different.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.041', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for patient: scar stiffness is different.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.23', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for patient: scar thickness is different.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for patient: scar more irregular.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for patient: overall opinion.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.68', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for observer: vascularity.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.18', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for observer: pigmentation.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for observer: thickness', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.36', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for observer: relief.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.78', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for observer: pliability.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.76', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for observer: surface area.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.97', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'groupDescription': 'Comparison between arms for observer: overall opinion.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 6 week postoperative appointment', 'description': "The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all patients or observers completed the scales. For the six items on the patient scale, N=44:52, but the overall opinion responding was N=43:51. For the observer scale the number responding was N=43:52 for vascularity, thickness, pliability, and surface area. N=42:52 for pigmentation and relief; N=42:50 for overall opinion.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'FG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}], 'periods': [{'title': 'Intention-to-Treat Analysis', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '110'}, {'groupId': 'FG001', 'numSubjects': '110'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Missing consent form', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Multifetal gestation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Body Mass Index>50', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Postpartum Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '103'}, {'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the Mayo Clinic Family Birth Center (labor and delivery) in Rochester, Minnesota. Subjects were recruited from December 2012 until the end of April 2014.', 'preAssignmentDetails': '220 subjects were randomized to suture or absorbable subcuticular staples and 206 were included in the final analysis with 103 in each group. One subject crossed over from absorbable subcuticular staples to suture intraoperatively, because the attending surgeon was not comfortable with the staple closure device.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Subcuticular Suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.'}, {'id': 'BG001', 'title': 'Subcuticular Staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000', 'lowerLimit': '27', 'upperLimit': '33'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '27', 'upperLimit': '34'}, {'value': '30.5', 'groupId': 'BG002', 'lowerLimit': '27', 'upperLimit': '34'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', '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': '103', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '206', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Resident year of postgraduate education', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '3'}, {'value': '2', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}], 'populationDescription': 'Intention-to-Treat Analysis'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2012-12-05', 'resultsFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2012-12-17', 'lastUpdatePostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-04-14', 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-04-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Surgical Time, All Resident Levels', 'timeFrame': 'Measured at the time of the procedure (day 1), approximately 1 hour after incision start', 'description': 'Total surgical time was defined as the time from incision start to incision completion. Measured for all resident education levels (1 to 4 years postgraduate).'}, {'measure': 'Skin Closure Time, All Resident Levels', 'timeFrame': 'Measured at the time of the procedure (day 1), approximately 1 hour after incision start', 'description': 'Measured for all resident education levels (1 to 4 years postgraduate).'}], 'secondaryOutcomes': [{'measure': 'Total Number of Participants With Postoperative Complications', 'timeFrame': 'From the day of the procedure (Day 1) for 6 weeks', 'description': 'Postoperative complications were assessed by chart review.'}, {'measure': 'Participants With Postoperative Complications, by Type', 'timeFrame': 'From the day of the procedure (Day 1) for 6 weeks', 'description': 'Postoperative complications were assessed by chart review.'}, {'measure': 'Postoperative Pain', 'timeFrame': 'From day of procedure until end of hospital stay (typical dismissal on day 4)', 'description': 'Post-operative pain was assessed by pain medication use through chart review.'}, {'measure': 'Number of Subjects Requiring Patient-controlled, Alternative Oral, or Single Dose IV/IM Analgesic', 'timeFrame': 'From day of procedure until end of hospital stay (typical dismissal on day 4)', 'description': 'Post-operative pain was assessed by pain medication use through chart review. These subjects required patient-controlled analgesia, or alternative oral analgesic, or a single dose of intravenous (IV) or intramuscular (IM) analgesic. Alternative oral analgesics included hydromorphone, hydrocodone/acetaminophen, or oxycodone/acetaminophen .'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'At the time of dismissal (typically day 3 or 4) and at 6 weeks postoperative appointment', 'description': 'Patient satisfaction was measured by questionnaire at the time of dismissal from the hospital and at their 6 week postpartum/postoperative exam. There were 4 questions: How satisfied are you with the appearance of your skin incision? How willing are you to recommend this same skin closure to a friend? How willing are you to have this same skin closure for your next cesarean section? What is your overall satisfaction with your surgical procedure, including the skin incision? For reporting purposes, possible answers for each item were grouped into negative (not at all, not very, or no opinion), or positive (somewhat or extremely).'}, {'measure': 'Surgeon Satisfaction (Per Procedure)', 'timeFrame': 'Immediately after the procedure (day 1)', 'description': 'Surgeon satisfaction was assessed by a 3-question questionnaire immediately after performing the procedure. The questions were: How satisfied are you with the appearance of the skin incision?" "How willing are you to recommend this skin closure (whether it was staples or suture) to a patient?" "How willing are you to use this skin closure (whether it was staples or suture) for your next cesarean section?" There were 5 possible responses to each question (not at all, not very, no opinion, somewhat, extremely), with "not at all,\' "not very," and "no opinion" being a negative response, and "somewhat" and "extremely " being a positive response. Categories reported were negative, (including no opinion), and positive.'}, {'measure': 'Cosmetic Outcome', 'timeFrame': 'Measured at 6 week postoperative appointment', 'description': "The cosmetic outcome will be assessed by patients and a blinded observer at the 6 week postpartum/postoperative exam using the Patient Observer Scar Assessment Scale (POSAS). The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. Again, a 10-point scale is used in which 10 corresponds to the worst imaginable scar."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subcuticular suture', 'Subcuticular staple', 'Skin closure', 'Incision closure', 'Wound'], 'conditions': ['Surgical Wound']}, 'referencesModule': {'references': [{'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': '9592605', 'type': 'BACKGROUND', 'citation': 'Jagger J, Bentley M, Tereskerz P. A study of patterns and prevention of blood exposures in OR personnel. AORN J. 1998 May;67(5):979-81, 983-4, 986-7 passim. doi: 10.1016/s0001-2092(06)62623-9.'}, {'pmid': '14520211', 'type': 'BACKGROUND', 'citation': "Jenkins TR. It's time to challenge surgical dogma with evidence-based data. Am J Obstet Gynecol. 2003 Aug;189(2):423-7. doi: 10.1067/s0002-9378(03)00587-8."}, {'pmid': '16260200', 'type': 'BACKGROUND', 'citation': 'Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.'}, {'pmid': '20216417', 'type': 'BACKGROUND', 'citation': 'Walsh CA. Evidence-based cesarean technique. Curr Opin Obstet Gynecol. 2010 Apr;22(2):110-5. doi: 10.1097/GCO.0b013e3283372327.'}]}, 'descriptionModule': {'briefSummary': 'Currently, the way doctors close the skin during cesarean section is different between surgeons and there is little evidence to support the use of one kind of closure over the other. At the Mayo Clinic Family Birth Center, skin is currently closed using an absorbable suture (or stitch), placed within the top layer of skin. At other institutions, a metal staple is often used to close the skin.\n\nThere is a new technique that uses special absorbable staples just beneath the skin. This technology may be equal to, or possibly better than, current skin closure techniques. However, there is currently little data to show how it compares. The purpose of this study is to compare the absorbable staple to the currently used absorbable suture. The data from this study will then be used to help determine the best technique for skin closure.', 'detailedDescription': 'Cesarean section is one of the most frequently performed surgical procedures worldwide. In the United States, the proportion of deliveries by cesarean has increased from approximately 21% in 1996 to 32.8% in 2010. Ultimately, the rising incidence of cesarean delivery results in increased surgical morbidity; including pain, blood loss, and surgical site infections, which leads to an increase in overall hospitalization days and healthcare costs. This volume of surgical procedures also carries the risk of blood and body fluid exposures to surgical staff. Suture needles contribute to 43.4% of all sharps injuries in surgical settings and 51.5% of sharp injuries to surgeons alone. Additionally, it was discovered that 20% of blood borne pathogen exposures on the Mayo Clinic Rochester campus in 2011 occurred in the Department of Obstetrics and Gynecology. Therefore, any quality improvement measure regarding cesarean sections has the potential to significantly impact overall surgical morbidity, bloodborne pathogen exposure, and healthcare costs at our institution. Reviews of current literature show a lack of evidence for many of the surgical steps during cesarean procedures. Thus, there is an urgent need to define evidence-based surgical techniques for each step, from incision to closure.\n\nThe optimal skin closure technique is simple, quick, cost-effective, and provides adequate tissue approximation with a good cosmetic outcome while minimizing the risk of infection, dehiscence, and pain. Ideally, needlestick injuries would also be eliminated. It is currently unknown which skin closure method is superior with regard to these outcomes.\n\nThe INSORB 20 (Incisive Surgical) is a new, single-use device for skin closure that aims to combine the speed of a staple with the cosmetic outcome of a subcuticular suture, while eliminating the need for staple removal. Additionally, it should reduce the incidence of needlestick injury. INSORB also claims to result in a "low maintenance wound" with less surgical site infection, lower inflammation, and increased patient comfort and satisfaction. However, data is limited comparing INSORB to the current standards of care (either staples or suture).\n\nThe purpose of this study is to determine if the new absorbable subcuticular staples (INSORB) improves outcomes compared to the current standard absorbable subcuticular suture for skin closure in cesarean sections.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Gestational age ≥ 24 weeks\n* Scheduled cesarean section for any indication\n* Pfannenstiel incision\n* Singleton gestation\n\nExclusion criteria:\n\n* Failure to consent\n* Gestational age \\< 24 weeks\n* Vaginal delivery\n* Intrauterine fetal death\n* Multifetal gestation\n* Suspected infection, i.e. chorioamnionitis\n* BMI \\> 50'}, 'identificationModule': {'nctId': 'NCT01753518', 'briefTitle': 'A Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Randomized Clinical Trial of Subcuticular Staples Versus Subcuticular Suture for Cesarean Section Skin Closure', 'orgStudyIdInfo': {'id': '12-003183'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Subcuticular suture', 'description': 'Subcuticular suture has been used for many years to close skin incisions.', 'interventionNames': ['Device: Subcuticular suture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subcuticular staple', 'description': 'Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.', 'interventionNames': ['Device: Subcuticular staple']}], 'interventions': [{'name': 'Subcuticular suture', 'type': 'DEVICE', 'otherNames': ['Monocryl'], 'description': 'subcuticular Monocryl suture closure', 'armGroupLabels': ['Subcuticular suture']}, {'name': 'Subcuticular staple', 'type': 'DEVICE', 'otherNames': ['Insorb'], 'description': 'subcuticular staple wound closure with INSORB 20 device', 'armGroupLabels': ['Subcuticular staple']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Jennifer Tessmer-Tuck, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Margaret L. Dow, M.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Margaret L. Dow, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}