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Clinical trial

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

ID
Name
Pro00087360
Description
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)
Trial arms
Trial start
2019-05-15
Estimated PCD
2023-01-09
Trial end
2023-01-09
Status
Completed
Phase
Early phase I
Treatment
Gemcitabine/ clindamycin
Comparison of saline solution rinse vs antibiotic rinse
Arms:
Antibiotic Irrigation
Normal saline
Comparison of saline solution rinse vs antibiotic rinse
Arms:
Saline Irrigation
Size
250
Primary endpoint
Surgical Site Infection
30 days
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 250, 'type': 'ACTUAL'}}
Updated at
2023-08-24

1 organization

1 product

1 drug

1 indication

Organization
Prisma Health-Upstate
Product
Gemcitabine + Clindamycin
Indication
Herniorrhaphy
Drug
Varlilumab