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

NCT ID: NCT06644612

Last Updated: 2025-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Abdominal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Single-blinded trials will be conducted where participants will be unaware of the intervention they will receive.

Study Groups

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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.

Group Type EXPERIMENTAL

Light Weight Mesh

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

Heavy Weight Mesh

Intervention Type PROCEDURE

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

Interventions

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Light Weight Mesh

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lady Reading Hospital, Pakistan

OTHER_GOV

Sponsor Role collaborator

Khyber Medical University Peshawar

OTHER

Sponsor Role lead

Responsible Party

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Dr Sheraz Fazid

Coordinator in Institute of Public Health and Social Science, Khyber Medical University Peshawar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dr Abdul Wahab

Role: PRINCIPAL_INVESTIGATOR

Lady Reading Hospital, Pakistan

Locations

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Lady Reading Hospital, Pakistan

Peshawar, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type BACKGROUND
PMID: 30339623 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27054138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17846703 (View on PubMed)

Other Identifiers

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KMU/DIR/CTU/2024/008

Identifier Type: -

Identifier Source: org_study_id

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