What side effects are associated with this type of intervention?

Open hernia repair commonly involves risks such as surgical site infections, chronic pain, and hernia recurrence. The use of vancomycin-soaked mesh in these procedures aims to reduce infection rates. However, vancomycin can cause side effects including kidney toxicity, hearing loss, and infusion-related reactions like 'red man syndrome.'

What prior FDA approvals exist?

The FDA has approved several antibiotics for the prevention of surgical site infections in open hernia repairs, focusing on agents that inhibit bacterial cell wall synthesis. Vancomycin, a glycopeptide antibiotic, is commonly used for patients at risk of MRSA colonization. Cefazolin, a first-generation cephalosporin, is another approved antibiotic frequently used for its broad-spectrum activity against skin flora. These antibiotics are often administered prophylactically to reduce the risk of infection associated with surgical implants, including meshes used in hernia repairs.

What other types of research exist?

Promising novel alternatives to vancomycin-soaked mesh for open hernia repair include the use of ceftazidime/avibactam, meropenem/vaborbactam, and antibiotic beads containing meropenem and daptomycin. These options have shown efficacy in preventing infections in other surgical contexts and could be considered for hernia repair.

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Vancomycin-Soaked Mesh for Open Hernia Repair

Phase 2 & 3

Waitlist Available

Research Sponsored by University of Saskatchewan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Open ventral or inguinal hernia repair

Be older than 18 years old

Must not have

Non-ventral or inguinal hernia repairs

Laparoscopic hernia repair

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include local reactions at the surgery site related to vancomycin, such as redness, pain, or swelling. There could also be a risk of allergic reactions to the antibiotic.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having or had an open hernia repair surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I had a hernia fixed using a minimally invasive surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

In open hernia repair, one common treatment involves soaking the surgical mesh in vancomycin, an antibiotic that inhibits bacterial cell wall synthesis. This mechanism is crucial as it prevents bacterial colonization and subsequent infections at the surgical site. For patients undergoing open hernia repair, this method significantly reduces the risk of mesh-related infections, leading to better recovery outcomes and fewer complications.

Management of complex ventral hernias: results of an international survey.Do we need antibiotic prophylaxis in endoscopic inguinal hernia repair? Results of the Herniamed Registry.