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Completed

NCT Number: NCT03945357

Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)

This is a study to determine if the incidence of infection at the Surgical SitE is impacted if with Antibiotic Irrigation is used during Ventral Hernia Repair (RINSE Trial)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prisma Health Upstate

Greenville, South Carolina, 29615, United States

About this study

Surgical site infection (SSI) is common after open ventral hernia repair. Numerous factors contribute, including patient comorbidities, operative technique, and degree of contamination of the case. SSI often requires prolonged hospital length of stay (LOS), readmission, or other procedural intervention. One potential intervention to reduce SSI is the use of antibiotic irrigation, which has been shown to reduce SSI in colorectal surgery in a recent randomized control trial. We retrospectively evaluated our use of dual antibiotic irrigation at the time of mesh placement during open ventral hernia repair (OVHR), demonstrating a significant reduction in SSI (16.5 vs 5.4%) using a combination of gentamicin and clindamycin irrigation when compared to saline alone.

We plan to complete a registry-based, randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative (AHSQC) to further assess the impact of dual antibiotic irrigation on SSI after OVHR with mesh. This will include patients undergoing open retromuscular (RM) repair with or without transversus abdominis myofascial advancement flap (TAR) with placement of permanent synthetic mesh (mid-weight, large-pore polypropylene). Power analysis based on only this subset of patients from our initial study indicates a total of 210 patients are needed to demonstrate a significant reduction in SSI using antibiotic irrigation vs saline irrigation alone.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >18 y/o.
  • Elective, open ventral hernia repair in a retromuscular fashion, with or without TAR.
  • Clean, clean-contaminated, or contaminated wounds.

Exclusion criteria

  • Age <18 y/o.
  • Pregnancy.
  • Emergency hernia repair.
  • Laparoscopic, robotic, or hybrid approach.
  • Dirty wounds.
  • Use of biologic or absorbable synthetic mesh.
  • Onlay, intraperitoneal or preperitoneal mesh placement.

Treatment and study plan

Gemcitabine/ clindamycin

Drug

Comparison of saline solution rinse vs antibiotic rinse

normal saline

Drug

Comparison of saline solution rinse vs antibiotic rinse

Primary outcomes

  1. Surgical Site Infection

    Time frame: 30 days

    Number of participants with Surgical Site Infections

Secondary outcomes

  1. Incidence of SSI Requiring Intervention

    Time frame: 30 days

    Number of participants with SSI requiring reoperation or other procedural intervention at 30 days.

Sponsors and collaborators

Lead sponsor

Prisma Health-Upstate

Other

Collaborators

  • Oregon Health and Science University
  • Penn State University
  • The Cleveland Clinic

Registry information

Acronym: RINSE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 10, 2019
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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