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

ConditionIncisional Hernia of Anterior Abdominal Wall
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Non consenting patients

patients with skin or deep tissue infections at the time of surgery

prior mesh infection from hernia repair will be excluded

entry into the gastro-intestinal system (i.e., need for hepaticojejunostomy for transplantation versus just a standard biliary-biliary anastomosis)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low molecular weight mesh

    Device

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Control GroupNo intervention 0 interventions
Group B: Treatment Group - MeshExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of incisional hernia post-operatively

The primary outcome will be incisional hernia rate at 1 year post-operatively.

Time frame
1 year

Secondary outcomes

1

Rate of incisional hernia post-operatively

Incisional hernia rates at post-operative year 2

Time frame
2 years
2

Rate of surgical complications

Assess rate of surgical complications as per Clavien Dindo classification

Time frame
2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Ethicon, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: