Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2025-12-29 @ 10:40 AM
Study NCT ID:
NCT07142395
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Delayed vs Primary Wound Closure After Emergency Laparotomy: Impact on Infection, Healing, and Hospital Stay
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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-08-22', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-08-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Hospital Stay', 'timeFrame': 'From date of surgery until date of hospital discharge, up to 28 days', 'description': 'Duration of stay (days) in hospital after laparotomy'}, {'measure': 'Wound dehiscence', 'timeFrame': 'From date of laparotomy to Four weeks post-operatively', 'description': 'A partial or total separation of previously approximated wound edges'}], 'primaryOutcomes': [{'measure': 'Wound Infection', 'timeFrame': 'From date of surgery to Four weeks postoperatively', 'description': 'Surgical Site infection - Presence any features of erythema, pain, pus discharge on examination of surgical wound and new onset fever (\\> 98.6 F)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wound infection', 'primary wound closure', 'delayed wound closure', 'Wound dehiscence'], 'conditions': ['Laparotomy Closure After Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out which type of wound closure after emergency abdominal surgery leads to fewer wound infections and better recovery: closing the wound immediately after surgery (called primary closure) or waiting a few days before closing the skin (called delayed primary closure).\n\nWound infection is a common problem after emergency abdominal surgery (also called laparotomy). Some surgeons close the skin right away, while others wait a few days to reduce the risk of infection.\n\nThis study will help find out which method is better.\n\nThe main questions the study aims to answer are:\n\n1. . Does delayed primary closure lower the rate of wound infection compared to primary closure?\n2. . Does the wound open up (wound dehiscence) less often with delayed closure?\n3. . Does delayed closure affect the length of hospital stay?\n\nIn this clinical trial:\n\n* Adult patients needing emergency abdominal surgery will be included.\n* Half the patients will have their wounds closed immediately (primary closure), and half will have delayed closure after 3-5 days of daily dressing.\n* All surgeries will be done by experienced surgeons using the same technique.\n* Patients will be followed for 4 weeks after surgery to monitor wound infection, wound opening, and length of hospital stay.\n\nThe results will help doctors choose the safest and most effective way to close surgical wounds after emergency abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 - 60 years of age\n* Either male or female gender and\n* Planned to undergo emergency laparotomy\n\nExclusion Criteria:\n\n* Patients undergoing second laparotomy\n* Re- laparotomy\n* On steroid therapy and\n* Patients who die within 28-days of surgery'}, 'identificationModule': {'nctId': 'NCT07142395', 'briefTitle': 'Comparing Delayed vs Primary Wound Closure After Emergency Laparotomy: Impact on Infection, Healing, and Hospital Stay', 'organization': {'class': 'OTHER', 'fullName': 'Bkahtawar Amin Medical and Dental College Multan'}, 'officialTitle': 'Comparison of Primary Skin Closure Versus Delayed Primary Skin Closure in Patients Undergoing Emergency Laparotomies', 'orgStudyIdInfo': {'id': 'U1111-1326-2839'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Primary Closure', 'description': 'Skin closed immediately after laparotomy', 'interventionNames': ['Procedure: Immediate skin closure']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Primary Closure', 'description': 'Skin closed 3 - 5 days after laparotomy', 'interventionNames': ['Procedure: Delayed primary closure']}], 'interventions': [{'name': 'Immediate skin closure', 'type': 'PROCEDURE', 'description': 'After laparotomy wounds will be closed primarily using no. 1 vicryl suture', 'armGroupLabels': ['Primary Closure']}, {'name': 'Delayed primary closure', 'type': 'PROCEDURE', 'description': 'Deeper layers of wound will be closed after surgery and loose mattress sutures will be applied to skin with prolene. After three to five days of daily dressing with bactericidal solution, the skin will be closed', 'armGroupLabels': ['Delayed Primary Closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Multan', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Bakhtawar Amin Medical and Dental College', 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'overallOfficials': [{'name': 'Amjad A Professor, FRCS', 'role': 'STUDY_CHAIR', 'affiliation': 'Bakhtawar Amin Medical and Dental College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bkahtawar Amin Medical and Dental College Multan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}