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NOT YET RECRUITING
NCT04512469
NA

Study on the Efficacy of Prophylactic on Lay Mesh in Preventing Post-operative Hernia in Liver Transplant Patients

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

Summary

Study Design: Single-blinded, randomized, prospective clinical trial. Study Population: End-stage liver disease patients' candidates for liver transplantation. Study procedures: Consenting patients will be divided into two matched groups: 1. CONTROL group - receiving a standard running fascial closure with PDS suture 2. TREATMENT group - receiving a standard running fascial closure with PDS suture PLUS a low molecular weight mesh. The mesh will be secured to the fascia extending 3 cm from the incisional site. There will be no modifications to routine post-operative wound care in both groups. However, the treatment group will have an additional drain placed at the incision site compared to the control group to reduce the risk of a seroma from placement of the mesh. Wound dressing will be removed on post-op day 2 and the wound will be assessed. Re-application of the dressing will occur thereafter until proper healing of the incision. An abdominal ultrasound will be done on all study participants at the 1- and 2-year mark postoperatively to look for objective evidence of a ventral incisional hernia. A CT scan will be performed if the abdominal ultrasound findings are inconclusive.

Official title: A Randomized Controlled Trial Examining the Efficacy of Prophylactic on Lay Mesh Versus Standardized Fascial Closure on Ventral Incisional Hernia Rates in Liver Transplant Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2020-09

Completion Date

2026-09

Last Updated

2020-08-13

Healthy Volunteers

Yes

Interventions

DEVICE

Low molecular weight mesh

Following liver implantation, the subcostal incision will be closed using a running fascial closure with absorbable 1-0 Polydioxanone (PDS) suture and staples, with the treatment group also receiving a mesh.