Clinical trial NCT03945357: Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
Official title: Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ventral Hernia Repair
Keywords: Infection
hernia repair
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: The Cleveland Clinic
name: Penn State University
name: Oregon Health and Science University
First posted: 2019-05-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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)

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.

Eligibility 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.

Primary outcomes:
measure: Surgical Site Infection
timeFrame: 30 days
Secondary outcomes:
measure: Incidence of SSI Requiring Intervention
timeFrame: 30 days
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
Study officials:
affiliation: Prisma Health-Upstate
name: Jeremy Warren, MD
role: PRINCIPAL_INVESTIGATOR
References: