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

Ventral Hernia Repair Clinical Trial

— RINSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03945357
• Other study ID #: Pro00087360
• Status: Completed
• Phase: Phase 3
• Start date: May 15, 2019
• Est. completion date: January 9, 2023

Study information

• Verified date: August 2023
• Source: Prisma Health-Upstate
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: January 9, 2023
• Est. primary completion date: January 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Infections
• Ventral Hernia Repair

Intervention

Drug:
• Gemcitabine/ clindamycin
Comparison of saline solution rinse vs antibiotic rinse
• Normal saline
Comparison of saline solution rinse vs antibiotic rinse

Locations

Country	Name	City	State
United States	Prisma Health Upstate	Greenville	South Carolina

Sponsors (4)

Lead Sponsor	Collaborator
Prisma Health-Upstate	Oregon Health and Science University, Penn State University, The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection	Number of participants with Surgical Site Infections	30 days
Secondary	Incidence of SSI Requiring Intervention	Number of participants with SSI requiring reoperation or other procedural intervention at 30 days.	30 days