Phase 3
N=250
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
Ventral Hernia Repair
Bottom Line
View on ClinicalTrials.gov: NCT03945357 ↗Enrolled (actual)
250
Serious AEs
5.6%
Results posted
Aug 2023
Primary outcome: Primary: Surgical Site Infection — 11; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Gemcitabine/ clindamycin (Drug); Normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Prisma Health-Upstate
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Site Infection |
11; 10 | — |
| SECONDARY Incidence of SSI Requiring Intervention |
8; 8 | — |
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)
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.
Data sourced from ClinicalTrials.gov (NCT03945357). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.