Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-29 @ 6:46 PM
Study NCT ID:
NCT06644612
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2024-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Light vs Heavy Weighted Mesh Repair in Primary Abdominal Hernia in Terms of Surgical Site Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Single-blinded trials will be conducted where participants will be unaware of the intervention they will receive.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly allocated into two groups: one group will undergo hernia repair using light-weighted polypropylene mesh, and the other group will receive heavy-weighted polypropylene mesh. The incidence of SSIs post-operatively will be compared between the two groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2024-10-14', 'studyFirstSubmitQcDate': '2024-10-14', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection (SSI)', 'timeFrame': '10 days', 'description': 'Incidence of Surgical Site Infection (SSI) within 10 days post-surgery. Using Complete Blood Count (CBC) and site of infection will be checked for the structure affected.'}], 'secondaryOutcomes': [{'measure': 'Post-operative Pain', 'timeFrame': '10 days', 'description': 'Post-operative pain severity measured using a standardized pain scale (Visual Analogue Scale). Higher scores indicate more severe pain. Scores are interpreted are from 0-4: Mild pain 5-7: Moderate pain, 7-10: Severe pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal Hernia', 'Surgical Site Infection', 'Light Weighted Mesh', 'Heavy Weighted Mesh', 'Randomized Controlled Trial'], 'conditions': ['Abdominal Hernia']}, 'referencesModule': {'references': [{'pmid': '30339623', 'type': 'BACKGROUND', 'citation': 'Ponten JEH, Leclercq WKG, Lettinga T, Heemskerk J, Konsten JLM, Bouvy ND, Nienhuijs SW. Mesh OR Patch for Hernia on Epigastric and Umbilical Sites (MORPHEUS-Trial): The Complete Two-year Follow-up. Ann Surg. 2019 Jul;270(1):33-37. doi: 10.1097/SLA.0000000000003086.'}, {'pmid': '27054138', 'type': 'BACKGROUND', 'citation': 'Rastegarpour A, Cheung M, Vardhan M, Ibrahim MM, Butler CE, Levinson H. Surgical mesh for ventral incisional hernia repairs: Understanding mesh design. Plast Surg (Oakv). 2016 Spring;24(1):41-50. doi: 10.4172/plastic-surgery.1000955.'}, {'pmid': '17846703', 'type': 'BACKGROUND', 'citation': 'Eriksen JR, Gogenur I, Rosenberg J. Choice of mesh for laparoscopic ventral hernia repair. Hernia. 2007 Dec;11(6):481-92. doi: 10.1007/s10029-007-0282-8. Epub 2007 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the incidence of surgical site infections (SSI) in patients undergoing abdominal hernia repair using either light or heavy-weighted polypropylene mesh. The study aims to determine which mesh type results in fewer SSIs, thereby guiding future surgical approaches to abdominal hernia repair.', 'detailedDescription': 'Hernias, a protrusion of abdominal contents through the abdominal wall, are often treated surgically using synthetic polypropylene mesh. Two varieties of polypropylene mesh exist: light and heavy weighted. The lighter mesh is softer, less allergenic, and potentially leads to fewer post-surgical complications, including SSIs. In contrast, heavier mesh, which has been traditionally used, consists of thicker threads with narrower gaps and has a higher chance of eliciting an immune response. This trial aims to assess the effectiveness of light mesh over heavy mesh in reducing SSIs in abdominal hernia repairs, thereby providing data to support best practices in surgical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 15 and above.\n* Patients undergoing primary abdominal hernia repair using light or heavy mesh.\n\nExclusion Criteria:\n\n* Patients with incisional hernias.\n* Patients with diabetes mellitus, chronic cough, steroid use, cancer, or immune-compromised status.'}, 'identificationModule': {'nctId': 'NCT06644612', 'briefTitle': 'Light vs Heavy Weighted Mesh Repair in Primary Abdominal Hernia in Terms of Surgical Site Infection', 'organization': {'class': 'OTHER', 'fullName': 'Khyber Medical University Peshawar'}, 'officialTitle': 'A Comparative Study of Light vs Heavy Weighted Polypropylene Mesh in Abdominal Hernia Repair: A Randomized Control Trial Focusing on Surgical Site Infections', 'orgStudyIdInfo': {'id': 'KMU/DIR/CTU/2024/008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group A (Light Mesh Group)', 'description': 'All the patients will be administered intravenous Antibiotics two hours before induction of anaesthesia. The surgical site will be shaved if needed after scrubbing the patient. Prolene suture material will be used to anchor the light mesh and suture the skin. A negative pressure drain will be placed if needed. The wound will be dressed with gauze dressing. Post-operatively daily dressing will be done by ward dispenser following full aseptic technique.', 'interventionNames': ['Procedure: Light Weight Mesh']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention Group B (Heavy Mesh Group)', 'description': 'All the patients will be administered intravenous antibiotics two hours before induction of anaesthesia. The surgical site will be shaved if needed after scrubbing the patient.\n\nProlene suture material will be used for anchoring the Heavy mesh and for suturing the skin. A negative pressure drain will be placed if needed. The wound will be dressed with a gauze dressing. Post-operatively daily dressing will be done by ward dispenser following full aseptic technique.', 'interventionNames': ['Procedure: Heavy Weight Mesh']}], 'interventions': [{'name': 'Light Weight Mesh', 'type': 'PROCEDURE', 'description': 'Participants will undergo abdominal hernia repair using light-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.', 'armGroupLabels': ['Intervention Group A (Light Mesh Group)']}, {'name': 'Heavy Weight Mesh', 'type': 'PROCEDURE', 'description': 'Participants will undergo abdominal hernia repair using heavy-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.', 'armGroupLabels': ['Intervention Group B (Heavy Mesh Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Peshawar', 'state': 'Khyber Pakhtunkhwa', 'country': 'Pakistan', 'facility': 'Lady Reading Hospital, Pakistan', 'geoPoint': {'lat': 34.008, 'lon': 71.57849}}], 'overallOfficials': [{'name': 'Dr Abdul Wahab', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lady Reading Hospital, Pakistan'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data requests can be submitted starting 12 months after article publication.', 'ipdSharing': 'YES', 'description': 'Data obtained through this study may be provided to qualified researchers with academic interested in the stated study area after its proper monitoring. Data or samples shared will be coded, with no PHI included. Prior permission of the investigators, participants and concerned departments will be obtained.', 'accessCriteria': 'Access can be requested by qualified researchers through proper approval of the investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khyber Medical University Peshawar', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lady Reading Hospital, Pakistan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator in Institute of Public Health and Social Science, Khyber Medical University Peshawar', 'investigatorFullName': 'Dr Sheraz Fazid', 'investigatorAffiliation': 'Khyber Medical University Peshawar'}}}}