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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

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

Clinicaltrials.gov identifier NCT03945357

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted January 31, 2020

Study Description

Brief summary:

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)

  • Condition or Disease:Ventral Hernia Repair
  • Intervention/Treatment: Drug: Gemcitabine/ clindamycin
    Drug: Normal saline
  • Phase: Phase 3
Detailed Description

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.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 250 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: The study design would be a registry-based RCT through the AHSQC to evaluate the effect of dual antibiotic irrigation at the time of mesh placement during open RM +/-TAR OVHR.
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2021
  • Estimated Study Completion Date: May 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: Antibiotic Irrigation
Antibiotic solution is prepared consisting of 240 mg gentamicin and 600 mg clindamycin in 500 ml saline to ensure proper concentration. This solution should be placed into the dissected retromuscular space AFTER placement and fixation of mesh. This should fill the cavity completely to the level of the skin. Irrigant is to be left to stand for a total of three minutes and then evacuated. Additional irrigation with saline PRIOR to the randomization is permitted at the surgeons' discretion for hemostasis with no requirement for duration. Additional antibiotic irrigation of the subcutaneous space after fascia closure should be performed prior to skin closure. This second irrigation is not timed.
Drug: Gemcitabine/ clindamycin
Comparison of saline solution rinse vs antibiotic rinse
Active Comparator: Saline Irrigation
Normal saline is to be placed into the dissected retromuscular space AFTER placement and fixation of mesh. This should fill the cavity completely to the level of the skin. Irrigant is to be left to stand for a total of three minutes and then evacuated. Additional irrigation with saline PRIOR to the randomization is permitted at the surgeons' discretion for hemostasis with no requirement for duration. Additional saline irrigation of the subcutaneous space after fascia closure should be performed prior to skin closure.
Drug: Normal saline
Comparison of saline solution rinse vs antibiotic rinse
Outcome Measures
  • Primary Outcome Measures: 1. Surgical Site Infection [ Time Frame: 30 days ]
    Incidence of surgical site infection (SSI) at 30 days
  • Secondary Outcome Measures: 1. Incidence of SSI requiring intervention [ Time Frame: 30 days ]
    Incidence of SSI requiring reoperation or other procedural intervention at 30 days.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: Jeremy Warren, MD (864) 522-2100 jeremy.warren@prismahealth.org

Contact: Leesa Judd, MSN 864-414-9146 leesa.judd@prismahealth.org

Locations

United States, South Carolina
Prisma Health Upstate
Greenville

Sponsors and Collaborators

Prisma Health-Upstate

Washington University School of Medicine

The Cleveland Clinic

Penn State University

Oregon Health and Science University

Ohio State University

New Hanover Regional Medical Center

University of Pennsylvania

Investigators

Principal Investigator: Jeremy Warren, MD Prisma Health-Upstate

More Information
  • Responsible Party: Prisma Health-Upstate
  • ClinicalTrials.gov Identifier: NCT03945357 History of Changes
  • Other Study ID Numbers: Pro00087360
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: January 31, 2020
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Plan Description: There will be no patient information shared
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Prisma Health-Upstate: Infection hernia repair
  • Additional relevant MeSH terms: Infection
    Hernia
    Hernia, Ventral