Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-02-01 @ 12:54 PM
Study NCT ID:
NCT00514566
Status:
TERMINATED
Last Update Posted:
2007-08-10
First Post:
2007-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PDS vs Polyamide for Midline Abdominal Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'whyStopped': 'Unacceptable incidence of wound dehiscence in the PDS group', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-08-08', 'studyFirstSubmitDate': '2007-08-08', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2007-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wound Complications associated with suture material used for closure- Wound Dehiscence, Wound Infection, Incisional Hernia, Suture Sinus, Scar Pain', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Factors independent of suture materials responsible for wound complications such as age, gender, type of surgery, degree of contamination, surgeon, and presence of a stoma', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polyamide', 'Polydioxanone', 'Midline', 'Abdominal', 'Closure'], 'conditions': ['Laparotomy']}, 'descriptionModule': {'briefSummary': 'Within the last decade the customary trend of using non absorbable sutures has changed, with numerous studies and meta-analyses advocating the use of slowly absorbable sutures, claiming comparable wound strength with significantly lower incidence of wound complications. It was the objective of this randomized clinical trial to compare two universally accepted suture materials, the non-absorbable Nylon and the slowly absorbable Polydioxanone for midline abdominal closure in the Indian context.', 'detailedDescription': '64 patients undergoing midline laparotomy were allocated, using block randomization, to mass closure of the abdominal wall with continuous polyamide (34 patients) or continuous polydioxanone (30 patients).\n\nThere was an alarmingly higher incidence of wound dehiscence in the PDS group requiring secondary suturing (Nylon 0; PDS 5). Mid-way through the trial, an interim analysis was performed which revealed an unacceptably high incidence of wound dehiscence in the PDS group. This necessitated a premature curtailment of the study. There was, however, a statistically significantly higher incidence of scar pain in the Nylon group (Nylon 9; PDS 1).\n\nThere is a need for a study with larger series, and PDS as a choice of suture for midline wound closure cannot be recommended.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients above 12 years of age undergoing midline abdominal fascial closure using a continuous technique in the Department of Surgery, Christian Medical College and Hospital\n\nExclusion Criteria:\n\n* All patients under 12 years of age\n* Gynaecological operations\n* Abdominal wall hernia repair'}, 'identificationModule': {'nctId': 'NCT00514566', 'acronym': 'PPMAC', 'briefTitle': 'PDS vs Polyamide for Midline Abdominal Closure', 'organization': {'class': 'OTHER', 'fullName': 'Christian Medical College and Hospital, Ludhiana, India'}, 'officialTitle': "Is Polydioxanone 'THE' Suture of Choice for Midline Abdominal Closure? Results of a Prospective Randomized Clinical Trial", 'orgStudyIdInfo': {'id': 'ChristianMCLudhiana'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Surgical Patient undergoing midline laparotomy closure', 'interventionNames': ['Device: Suture for midline abdominal closure']}], 'interventions': [{'name': 'Suture for midline abdominal closure', 'type': 'DEVICE', 'otherNames': ['Ethicon Inc., Loop no. 1, 150 cm suture length'], 'description': 'closure with Polyamide or Polydioxanone', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '141008', 'city': 'Ludhiana', 'state': 'Punjab', 'country': 'India', 'facility': 'Christian Medical College and Hospital', 'geoPoint': {'lat': 30.91204, 'lon': 75.85379}}], 'overallOfficials': [{'name': 'Rajeev Kapoor, MS(Gen Surg)', 'role': 'STUDY_CHAIR', 'affiliation': 'Christian Medical College and Hospital, Ludhiana, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Christian Medical College and Hospital, Ludhiana, India', 'class': 'OTHER'}}}}