Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-25 @ 6:59 PM
Study NCT ID:
NCT01988168
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2013-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closure of Skin in ChorioAmnionitis Research Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002821', 'term': 'Chorioamnionitis'}, {'id': 'D011251', 'term': 'Pregnancy Complications, Infectious'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005322', 'term': 'Fetal Membranes, Premature Rupture'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D010922', 'term': 'Placenta Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-11', 'studyFirstSubmitDate': '2013-10-31', 'studyFirstSubmitQcDate': '2013-11-19', 'lastUpdatePostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient recruitment rate', 'timeFrame': '1 year', 'description': 'The patient recruitment rate will be calculated as the total number of women successfully recruited to the trial divided by the total duration of the trial.'}], 'secondaryOutcomes': [{'measure': 'Follow-up rates', 'timeFrame': '6 months post-operative', 'description': 'Number of women successfully contacted at 6 weeks and at 6 months post-partum divided by the total number of women randomized in the trial'}, {'measure': 'Wound infection', 'timeFrame': '6 months post-operative', 'description': 'Number of women who experience a wound infection divided by the total number of eligible women who participate in the trial.'}, {'measure': 'Wound disruption', 'timeFrame': '6 months post-operative', 'description': 'Number of women who experience a wound disruption divided by the total number of eligible women who participate in the trial.'}, {'measure': 'Wound cosmesis', 'timeFrame': '6 months post-operative', 'description': 'Wound cosmesis will be assessed using the POSAS Observer scale, which is directed at physicians, and the POSAS Patient scale, which is directed at patients'}, {'measure': 'Patient satisfaction', 'timeFrame': '6 months post-operative', 'description': 'Using the POSAS Patient Scale, patient satisfaction will be assessed.'}, {'measure': 'Participation rate', 'timeFrame': '1 year', 'description': 'The trial participation rate will be calculated as the percentage of eligible women who agreed to participate in the trial divided by the total number of eligible women approached to participate in the trial.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Suture Techniques', 'Sutures', 'Surgical Staplers'], 'conditions': ['Chorioamnionitis', 'Pregnancy Complications, Infectious', 'Complications; Cesarean Section', 'Postoperative Complications']}, 'descriptionModule': {'briefSummary': 'The purpose of the CSCAR pilot study is to improve the design of a full-scale trial by determining the patient recruitment rate and participation rate. The objective of the full-scale trial is to determine the optimal method of skin closure after Caesarean delivery in women with chorioamnionitis, which is an acute inflammation of the membranes and chorion of the placenta, seen typically after rupture of membranes with ascending polymicrobial bacterial infection. Women in labour with chorioamnionitis will be randomized at the time of Caesarean delivery to skin closure with either staples or sutures. The women will be followed at 6 weeks and 6 months post-partum in order to establish the occurrence of surgical site infection and wound disruption, as well as evaluation of the scar and other secondary questions.\n\nThe investigators hypothesis is that closure of skin with sutures will have a rate of wound infection that is no higher than the rate of wound infection when closing skin with staples. The investigators also hypothesize that closure with sutures will have a decreased rate of wound disruption, increased patient satisfaction and decreased length of hospital stay compared to skin closure with staples.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of chorioamnionitis (Fever ≥ 38.0°C AND at least TWO of: Maternal tachycardia: Heart rate \\> 100bpm, Fetal tachycardia: Baseline heart rate \\> 160bpm, Uterine tenderness, Foul smelling / purulent vaginal discharge, White Blood Cell count \\> 15,000 cells/mm3)\n* Caesarean delivery with Pfannenstiel incision\n* Pregnancies \\>24 weeks\n* Scheduled or non-elective procedures\n* Primary or repeat Caesarean delivery\n* No restrictions based on BMI\n* No exclusions due to DM (GDM or non GDM)\n* No exclusions due to multiple gestation pregnancy\n\nExclusion Criteria:\n\n* Non-Pfannenstiel incision\n* Immune compromising disease\n* History of keloid formation\n* Chronic steroid use\n* Allergy to staples\n* Planned postpartum care at another facility'}, 'identificationModule': {'nctId': 'NCT01988168', 'acronym': 'CSCAR', 'briefTitle': 'Closure of Skin in ChorioAmnionitis Research Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Closure of Skin in ChorioAmnionitis Research Pilot Study', 'orgStudyIdInfo': {'id': 'H13-03009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Suture closure', 'description': 'Closure of skin with a running subcuticular, absorbable monofilament suture.', 'interventionNames': ['Procedure: Suture closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Staples closure', 'description': 'Closure of skin with stainless-steel surgical staples.', 'interventionNames': ['Procedure: Staples closure']}], 'interventions': [{'name': 'Suture closure', 'type': 'PROCEDURE', 'otherNames': ['3-0 Monocryl suture (from Ethicon)'], 'description': "A running subcuticular suture is placed by taking horizontal bites through the papillary dermis on alternating sides of the wound. An absorbable suture is used and left in place until degraded and absorbed by the patient's tissues.", 'armGroupLabels': ['Suture closure']}, {'name': 'Staples closure', 'type': 'PROCEDURE', 'description': 'Surgical stapling devices re-appose skin edges with stainless steel or titanium staples. A second operator everts the wound skin edges while the operator applies staples along the incision. Staples can be removed on post-operative day 2 or 3, or delayed further according the surgeon preference based on patient characteristics.', 'armGroupLabels': ['Staples closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6H 3N1', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Ellen M Giesbrecht, MD', 'role': 'CONTACT', 'email': 'egiesbrecht@cw.bc.ca', 'phone': '604-875-2424'}, {'name': 'Ellen M Giesbrecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jennifer A Hutcheon, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Julie E van Schalkwyk, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Michael WH Suen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Children's and Women's Health Centre of British Columbia", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Ellen M Giesbrecht, MD', 'role': 'CONTACT', 'email': 'egiesbrecht@cw.bc.ca', 'phone': '604-872-5484'}], 'overallOfficials': [{'name': 'Ellen M Giesbrecht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia; Site Head, Department of Obstetrics, BC Women's Hospital"}, {'name': 'Jennifer A Hutcheon, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor, Division of Maternal Fetal Medicine, Department of Obstetrics and Gynaecology, University of British Columbia'}, {'name': 'Julie E van Schalkwyk, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Assistant Professor, Division of General Gynaecology & Obstetrics, Department of Obstetrics and Gynaecology, University of British Columbia'}, {'name': 'Michael WH Suen, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Resident, Department of Obstetrics and Gynaecology, University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': "BC Children's Hospital Research Institute", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Ellen Giesbrecht', 'investigatorAffiliation': 'University of British Columbia'}}}}