Light vs Heavy Weighted Mesh Repair in Primary Abdominal Hernia in Terms of Surgical Site Infection

NCT06644612 | Completed DMC

• 1 other identifier: KMU/DIR/CTU/2024/008
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Abdominal Hernia

Keywords

Abdominal Hernia; Surgical Site Infection; Light Weighted Mesh; Heavy Weighted Mesh; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection (SSI)

  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.

  10 days

Secondary Outcomes (1)

• Post-operative Pain

  10 days

Study Arms (2)

Intervention Group A (Light Mesh Group)

EXPERIMENTAL

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.

Procedure: Light Weight Mesh

Intervention Group B (Heavy Mesh Group)

ACTIVE COMPARATOR

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 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.

Procedure: Heavy Weight Mesh

Interventions

Light Weight Mesh PROCEDURE

Participants will undergo abdominal hernia repair using light-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.

Intervention Group A (Light Mesh Group)

Heavy Weight Mesh PROCEDURE

Participants will undergo abdominal hernia repair using heavy-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.

Intervention Group B (Heavy Mesh Group)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 15 and above.
• Patients undergoing primary abdominal hernia repair using light or heavy mesh.

You may not qualify if:

• Patients with incisional hernias.
• Patients with diabetes mellitus, chronic cough, steroid use, cancer, or immune-compromised status.

Sponsors & Collaborators

• Khyber Medical University Peshawar: lead
• Lady Reading Hospital, Pakistan: collaborator

Study Sites (1)

Lady Reading Hospital, Pakistan

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (3)

• 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: 30339623 BACKGROUND

• 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: 27054138 BACKGROUND

• 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.

  PMID: 17846703 BACKGROUND

MeSH Terms

Conditions

Hernia, Abdominal; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Wound Infection; Infections; Postoperative Complications; Pathologic Processes

Study Officials

• Dr Abdul Wahab

  Lady Reading Hospital, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded trials will be conducted where participants will be unaware of the intervention they will receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator in Institute of Public Health and Social Science, Khyber Medical University Peshawar

Model Details: 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.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: August 1, 2024
• Primary Completion: February 28, 2025
• Study Completion: April 15, 2025
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data requests can be submitted starting 12 months after article publication.
• Access Criteria: Access can be requested by qualified researchers through proper approval of the investigators.

Locations

PA (1)