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CompletedNCT06644612Updated Sep 2, 2025

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

An interventional study of Light Weight Mesh and Heavy Weight Mesh in Abdominal Hernia, sponsored by Khyber Medical University Peshawar. Completed at 1 site in Pakistan. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.

Sponsored by Khyber Medical University Peshawar · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
15 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Abdominal Hernia

Keywords

  • Abdominal Hernia
  • Surgical Site Infection
  • Light Weighted Mesh
  • Heavy Weighted Mesh
  • Randomized Controlled Trial
03

In context

Hernia, Abdominal

82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.

This study's enrollment of 106 is above the median of 90 across 48 interventional studies indexed under Hernia, Abdominal.

Browse Hernia, Abdominal studies →

Lead sponsor

Khyber Medical University Peshawar is the lead sponsor of 54 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with incisional hernias.
  • Patients with diabetes mellitus, chronic cough, use, cancer, or immune-compromised status.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
106 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • ProcedureLight Weight Mesh

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

  • ProcedureHeavy Weight Mesh

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

06

What researchers measure

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.

    Time frame: 10 days

Secondary outcomes

  1. 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

    Time frame: 10 days

07

Study locations

1 site
  • Lady Reading Hospital, Pakistan
    Peshawar, Khyber Pakhtunkhwa 25000, Pakistan
08

References and documents

Publications

  • 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. PubMed 30339623 ↗
  • 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. PubMed 27054138 ↗
  • 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. PubMed 17846703 ↗

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 2, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06644612
Lead sponsor
Khyber Medical University Peshawar
Collaborators
Lady Reading Hospital, Pakistan
Responsible party
Dr Sheraz Fazid (Coordinator in Institute of Public Health and Social Science, Khyber Medical University Peshawar, Khyber Medical University Peshawar) — Principal investigator
First posted
Oct 16, 2024
Start date
Aug 1, 2024
Primary completion
Feb 28, 2025
Completion
Apr 15, 2025
Last update
Sep 2, 2025

Study contacts

Dr Abdul Wahab
principal investigator · Lady Reading Hospital, Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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