Vancomycin-Soaked Mesh for Open Hernia Repair

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: University of Saskatchewan

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests if soaking surgical meshes in an antibiotic solution before hernia surgery can reduce infection rates. It targets patients having open hernia repairs to prevent mesh infections by using an antibiotic to kill bacteria. Current literature regarding the use of antibiotic-coated hernia mesh is limited but does show that these devices can inhibit bacterial growth and prevent mesh infection.

Eligibility Criteria

This trial is for individuals undergoing open ventral or inguinal hernia repair surgery. It's not suitable for those who are having non-ventral or non-inguinal hernia repairs, or those whose procedure will be done laparoscopically.

Inclusion Criteria

I am having or had an open hernia repair surgery.

Exclusion Criteria

I have had surgery for a hernia that is not in the belly button or groin area.

I had a hernia fixed using a minimally invasive surgery.

Participant Groups

The study is testing if soaking the mesh in vancomycin (an antibiotic) before using it in open hernia repair surgeries can reduce infection rates compared to using plain mesh without antibiotic treatment.

2Treatment groups

Experimental Treatment

Active Control

Group I: vancomycin-soaked meshExperimental Treatment1 Intervention

use of vancomycin-soaked mesh for open hernia repair

Group II: plain meshActive Control1 Intervention

standard practice of using plain mesh (non vancomycin-soaked) for open hernia repair