Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-25 @ 6:57 PM
Study NCT ID:
NCT04785404
Status:
COMPLETED
Last Update Posted:
2021-07-08
First Post:
2021-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patients will be randomly distributed to two groups. Group A patients will have skin wounds stithed after stoma reversal while in secondary closure group B, wound will be allowed to heal by secondary intention'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-05', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical site infection', 'timeFrame': '30 days', 'description': 'skin wound infection at surgical site will be observed on CDC guidelines'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['skin closure', 'stoma reversal'], 'conditions': ['Wound Infection']}, 'referencesModule': {'references': [{'pmid': '36841997', 'type': 'DERIVED', 'citation': 'Akbar I, Javed Z, Batool N. Primary versus secondary closure of stoma reversal skin wound: Randomized controlled trial. J Pak Med Assoc. 2023 Jan;73(1):4-8. doi: 10.47391/JPMA.3771.'}]}, 'descriptionModule': {'briefSummary': 'to compare infection rate stoma reversal skin wound after primary or secondary closure', 'detailedDescription': 'There will be two groups. In group A, skin will be stitched with prolene while in group B skin will be left open to follow up till 1 month and wound observed for infection according to CDC guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* . All patients who undergo ileostomy or colostomy reversal will be included\n\nExclusion Criteria:\n\n* included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc'}, 'identificationModule': {'nctId': 'NCT04785404', 'briefTitle': 'Primary Versus Secondary Closure of Stoma-Reversal Skin Wound', 'organization': {'class': 'OTHER', 'fullName': 'Ayub Teaching Hospital'}, 'officialTitle': 'Primary Versus Secondary Closure of Stoma-Reversal Skin Wound: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AyubTH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'primary skin closure', 'description': 'in this group, skin wound will be primarily closed', 'interventionNames': ['Procedure: primary skin closure']}, {'type': 'NO_INTERVENTION', 'label': 'secondary skin closure', 'description': 'skin will be left open to heal by secondary intention'}], 'interventions': [{'name': 'primary skin closure', 'type': 'PROCEDURE', 'description': 'skin will be stitched after stoma reversal to heal by primary intention', 'armGroupLabels': ['primary skin closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22040', 'city': 'Abbottābād', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Ayub teaching hospital'}], 'overallOfficials': [{'name': 'Zanib Javed, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ayub Teaching Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'after publication', 'ipdSharing': 'YES', 'description': 'will be shared after publication', 'accessCriteria': 'request will be reviewed by the investigators and and further decision regarding access will be made.after publication in indexed journal it will be available online'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ayub Teaching Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}