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

NCT03945357 | Completed Phase 3 Results FDA Drug

• 1 other identifier: Pro00087360
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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)

Conditions

Ventral Hernia Repair

Keywords

Infection; hernia repair

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  Number of participants with Surgical Site Infections

  30 days

Secondary Outcomes (1)

• Incidence of SSI Requiring Intervention

  30 days

Study Arms (2)

Saline Irrigation

ACTIVE COMPARATOR

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

Antibiotic Irrigation

ACTIVE COMPARATOR

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

Interventions

Gemcitabine/ clindamycin DRUG

Comparison of saline solution rinse vs antibiotic rinse

Antibiotic Irrigation

Normal saline DRUG

Comparison of saline solution rinse vs antibiotic rinse

Saline Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prisma Health-Upstate: lead
• The Cleveland Clinic: collaborator
• Penn State University: collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

Prisma Health Upstate

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Gemcitabine; Clindamycin; Saline Solution

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Aimee Hanvey
• Organization: Prisma Health

aimee.hanvey@prismahealth.org

864-760-7350

Study Officials

• Jeremy Warren, MD

  Prisma Health-Upstate

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 10, 2019
• Study Start: May 15, 2019
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: August 24, 2023
• Results First Posted: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)