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

• Sponsor: Prisma Health-Upstate (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03945357
• Collaborator: Washington University School of Medicine (Other), The Cleveland Clinic (Other), Penn State University (Other), Oregon Health and Science University (Other), Ohio State University (Other), New Hanover Regional Medical Center (Other), University of Pennsylvania (Other)
• Enrollment: 250
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 49.5
• Patients Per Site Per Month: 5

Study Details

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	Intervention/Treatment	Phase
Ventral Hernia Repair	Drug: Gemcitabine/ clindamycin; Drug: Normal saline	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
• Anticipated 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.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 15, 2019
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures

1. Surgical Site Infection [30 days]

   Incidence of surgical site infection (SSI) at 30 days

Secondary Outcome Measures

1. Incidence of SSI requiring intervention [30 days]

   Incidence of SSI requiring reoperation or other procedural intervention at 30 days.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Prisma Health Upstate	Greenville	South Carolina	United States	29615

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prisma Health-Upstate
• ClinicalTrials.gov Identifier: NCT03945357
• Other Study ID Numbers: Pro00087360
• First Posted: May 10, 2019
• Last Update Posted: Jul 21, 2022
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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.: No
• Keywords provided by Prisma Health-Upstate: Infection; hernia repair
• Additional relevant MeSH terms: Infections; Hernia; Hernia, Ventral; Gemcitabine; Clindamycin; Clindamycin palmitate; Clindamycin phosphate

Study Results

No Results Posted as of Jul 21, 2022