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

NCT03945357 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-08-24

Study results available
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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

Interventions

DRUG

Gemcitabine/ clindamycin

Comparison of saline solution rinse vs antibiotic rinse

DRUG

Normal saline

Comparison of saline solution rinse vs antibiotic rinse

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Penn State University

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Prisma Health-Upstate

    lead OTHER

Principal Investigators

  • Jeremy Warren, MD · Prisma Health-Upstate

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-15
Primary Completion
2023-01-09
Completion
2023-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945357 on ClinicalTrials.gov