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Antibiotic

Antibiotic Irrigation for Ventral Hernia Repair (RINSE Trial)

Phase 3

Waitlist Available

Led By Jeremy Warren, MD

Research Sponsored by Prisma Health-Upstate

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

RINSE Trial Summary

This trial is testing whether using antibiotic irrigation during surgery can reduce the risk of infection at the surgical site.

Eligible Conditions

Ventral Hernia Repair

RINSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical Site Infection

Secondary outcome measures

Incidence of SSI Requiring Intervention

RINSE Trial Design

2Treatment groups

Active Control

Group I: Antibiotic IrrigationActive Control1 Intervention

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.

Group II: Saline IrrigationActive Control1 Intervention

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.

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Find a Location

Who is running the clinical trial?

Ohio State UniversityOTHER

827 Previous Clinical Trials

502,501 Total Patients Enrolled

New Hanover Regional Medical CenterOTHER

6 Previous Clinical Trials

732 Total Patients Enrolled

University of PennsylvaniaOTHER

2,000 Previous Clinical Trials

42,879,838 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How is Saline Irrigation commonly used?

"Saline Irrigation is commonly used to treat acne vulgaris, however it can also help patients suffering from small cell lung cancer (sclc), bacterial endocarditis, and non-small cell lung carcinoma."

Answered by AI

Is it legally permissible to use Saline Irrigation in the United States?

"There is some clinical data supporting Saline Irrigation's efficacy, and it has undergone multiple rounds of testing to confirm its safety. For these reasons, our team at Power gave it a score of 3."

Answered by AI

Are patients still being accepted into this program?

"The latest information from clinicaltrials.gov indicates that this study is not presently looking for new participants. The trial was initially posted on May 15th, 2019 and updated as recently as July 20th, 2022. Although this particular research project isn't currently underway, there are 1,455 other medical trials enrolling patients right now."

Answered by AI

What is the evidence base for Saline Irrigation?

"Currently, 478 ongoing clinical trials are studying Saline Irrigation with 142 in Phase 3. Some of the many global locations conducting these trials for Saline Irrigation include Adelaide, South Australia."

Answered by AI

How many participants are being sought for this clinical trial?

"This study has completed recruitment for patients. The listing was created on May 15th, 2019 and updated most recently on July 20th, 2022. If you are interested in other studies, 977 trials are actively recruiting candidates for ventral hernia repair and 478 trials require participants for Saline Irrigation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2019. "Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03945357.