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

A Comparative Study of Light vs Heavy Weighted Polypropylene Mesh in Abdominal Hernia Repair: A Randomized Control Trial Focusing on Surgical Site Infections

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Hernia
• Intervention / Treatment: Procedure: Light Weight Mesh; Procedure: Heavy Weight Mesh

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Khyber Pakhtunkhwa
    • Peshawar, Khyber Pakhtunkhwa, Pakistan, 25000
      • Lady Reading Hospital, Pakistan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group A (Light Mesh Group); 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; Participants will undergo abdominal hernia repair using light-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.
Active Comparator: Intervention Group B (Heavy Mesh Group); 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; Participants will undergo abdominal hernia repair using heavy-weighted polypropylene mesh. Standard post-operative care and antibiotic prophylaxis will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain	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	10 days

Collaborators and Investigators

• Sponsor: Khyber Medical University Peshawar
• Collaborators: Lady Reading Hospital, Pakistan
• Investigators: Principal Investigator: Dr Abdul Wahab, Lady Reading Hospital, Pakistan

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Actual): February 28, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: October 14, 2024
• First Submitted That Met QC Criteria: October 14, 2024
• First Posted (Actual): October 16, 2024

Study Record Updates

• Last Update Posted (Estimated): September 2, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Surgical Site Infection; Randomized Controlled Trial; Abdominal Hernia; Light Weighted Mesh; Heavy Weighted Mesh
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Pathological Conditions, Anatomical; Infections; Hernia; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection; Hernia, Abdominal
• Other Study ID Numbers: KMU/DIR/CTU/2024/008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing Time Frame: Data requests can be submitted starting 12 months after article publication.
• IPD Sharing Access Criteria: Access can be requested by qualified researchers through proper approval of the investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No