Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT01713751
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2012-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Site Infection Rates in Obese Patients After Cesarean Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-24', 'studyFirstSubmitDate': '2012-10-14', 'studyFirstSubmitQcDate': '2012-10-24', 'lastUpdatePostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '30 days after the operative procedure', 'description': 'We used the definition devised and adopted by the Center for Disease Control and Prevention.'}], 'secondaryOutcomes': [{'measure': 'Skin closure time', 'timeFrame': '15 minutes'}, {'measure': 'Postoperative pain', 'timeFrame': '48 hours', 'description': 'Measured by 10-cm visual analogue scale, zero being no pain and ten the worst possible pain'}, {'measure': 'Short-term cosmetic wound outcome', 'timeFrame': '30 days', 'description': 'We used Stony Brook Scar Evaluation Scale'}, {'measure': 'Overall women satisfaction', 'timeFrame': '30 days', 'description': 'A questionnaire is used to check the patient satisfaction (satisfied versus unsatisfied) regarding the wound appearance and wound related pain'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Surgical site infection', 'Cesarean section'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '24272023', 'type': 'DERIVED', 'citation': 'Ibrahim MI, Moustafa GF, Al-Hamid AS, Hussein MR. Superficial incisional surgical site infection rate after cesarean section in obese women: a randomized controlled trial of subcuticular versus interrupted skin suturing. Arch Gynecol Obstet. 2014 May;289(5):981-6. doi: 10.1007/s00404-013-3098-z. Epub 2013 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.', 'detailedDescription': 'This is a randomized controlled trial conducted in Ain-Shams University Maternity Hospital on the period from March 2012 till August 2012. It included 130 pregnant women who underwent elective Cesarean section.\n\nThe aim of this study is to determine the surgical site infection rate and patient satisfaction for subcuticular versus interrupted mattress suture in closure of skin at Cesarean delivery in obese patients.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: any female in childbearing period.\n* Women planned for elective Cesarean section.\n* Obese women (BMI ≥ 30 Kg/m2). Our study calculated the BMI of patients from their weight and height at admission, because the pre-pregnancy BMI was not available for all patients, and we hypothesized that the BMI at admission was a better indicator of body mass during the at-risk time for development of SSI than was the pre-pregnancy BMI.\n\nExclusion Criteria:\n\n* Women who had concurrent overt infection (e.g.chorioamnionitis, pyelonephritis or chest infection).\n* Women who had intraoperative events that may themselves predispose to perioperative infection (e.g. bowel injury, operative time more than 90 minutes, major blood loss).\n* Women who had hemoglobin less than 10g/dl, preeclampsia, diabetes, rupture of membranes more than 12 hours, corticosteroid therapy.\n* Patients who had non Pfannenstiel incision.'}, 'identificationModule': {'nctId': 'NCT01713751', 'briefTitle': 'Surgical Site Infection Rates in Obese Patients After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Surgical Site Infection Rates of Two Different Skin Closure Methods Used in Obese Patients After Cesarean Delivery', 'orgStudyIdInfo': {'id': 'ASUOGRCT03-2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Interrupted suturing Group', 'description': 'Includes women who have their skin closed with interrupted mattress stitches using non-absorbable polypropylene \\[Prolene®\\]', 'interventionNames': ['Other: Interrupted suturing']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subcuticular suturing Group', 'description': 'Includes women who have their skin closed with subcuticular stitches using non-absorbable polypropylene \\[Prolene®\\].', 'interventionNames': ['Other: Subcuticular suturing']}], 'interventions': [{'name': 'Interrupted suturing', 'type': 'OTHER', 'description': 'Skin is closed with interrupted mattress stitches using non-absorbable polypropylene \\[Prolene®\\]', 'armGroupLabels': ['Interrupted suturing Group']}, {'name': 'Subcuticular suturing', 'type': 'OTHER', 'description': 'Skin is closed with subcuticular stitches using non-absorbable polypropylene \\[Prolene®\\]', 'armGroupLabels': ['Subcuticular suturing Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Moustafa I. Ibrahim, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Obstetrics & Gynecology Faculty of Medicine, Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Ellaithy', 'investigatorAffiliation': 'Ain Shams University'}}}}