CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 250 enrolled
Drug / intervention
Gemcitabine/ clindamycin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Age 18 years or older
  • ✓Elective open ventral hernia repair using retromuscular technique, with or without TAR (Transversus Abdominis Release)
  • ✓Clean, clean-contaminated, or contaminated surgical wounds
Key exclusion· 7
  • ✕Age under 18 years
  • ✕Pregnancy
  • ✕Emergency hernia repair
  • ✕Laparoscopic, robotic, or hybrid surgical approach

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03945357
NCT03945357Phase 3Completed
CompareCT.gov

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

Prisma Health-Upstate·interventional·Posted May 10, 2019·Updated Aug 24, 2023

In Brief

A Phase 3 clinical trial evaluating Gemcitabine/ clindamycin and Normal saline for Ventral Hernia Repair. Completed, enrolled 250 participants across 1 site.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVentral Hernia Repair
CountriesUnited States
CollaboratorsThe Cleveland Clinic, Penn State University, Oregon Health and Science University

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 10, 2019
Enrollment StartMay 15, 2019
Primary CompletionJan 9, 2023
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 7.1 years ago

Interventions

Gemcitabine/ clindamycindrug

Comparison of saline solution rinse vs antibiotic rinse

Normal salinedrug

Comparison of saline solution rinse vs antibiotic rinse