Clinical trial NCT06644612: Light vs Heavy Weighted Mesh Repair in Primary Abdominal Hernia in Terms of Surgical Site Infection
Official title: A Comparative Study of Light vs Heavy Weighted Polypropylene Mesh in Abdominal Hernia Repair: A Randomized Control Trial Focusing on Surgical Site Infections
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Abdominal Hernia
Keywords: Abdominal Hernia
Surgical Site Infection
Light Weighted Mesh
Heavy Weighted Mesh
Randomized Controlled Trial
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
Collaborators: name: Lady Reading Hospital, Pakistan
First posted: 2024-10-16
Enrollment: 106
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical Site Infection (SSI)
timeFrame: 10 days
Secondary outcomes:
measure: Post-operative Pain
timeFrame: 10 days
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital, Pakistan
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Lady Reading Hospital, Pakistan
name: Dr Abdul Wahab
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.