A Phase 3 interventional study of Gemcitabine/ clindamycin and Normal saline in Ventral Hernia Repair, sponsored by Prisma Health-Upstate. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-24.
Sponsored by Prisma Health-Upstate · Phase 3, Interventional, and Treatment
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)
Surgical site infection (SSI) is common after open ventral hernia repair. Numerous factors contribute, including patient comorbidities, operative technique, and degree of contamination of the case. SSI often requires prolonged hospital length of stay (LOS), readmission, or other procedural intervention. One potential intervention to reduce SSI is the use of antibiotic irrigation, which has been shown to reduce SSI in colorectal surgery in a recent randomized control trial. We retrospectively evaluated our use of dual antibiotic irrigation at the time of mesh placement during open ventral hernia repair (OVHR), demonstrating a significant reduction in SSI (16.5 vs 5.4%) using a combination of gentamicin and clindamycin irrigation when compared to saline alone.
We plan to complete a registry-based, randomized clinical trial (RCT) through the Americas Hernia Society Quality Collaborative (AHSQC) to further assess the impact of dual antibiotic irrigation on SSI after OVHR with mesh. This will include patients undergoing open retromuscular (RM) repair with or without transversus abdominis myofascial advancement flap (TAR) with placement of permanent synthetic mesh (mid-weight, large-pore polypropylene). Power analysis based on only this subset of patients from our initial study indicates a total of 210 patients are needed to demonstrate a significant reduction in SSI using antibiotic irrigation vs saline irrigation alone.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 250 is above the median of 120 across 4,200 interventional studies indexed under Infections.
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Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
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Exclusion Criteria:
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.
Drug: Normal saline
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.
Drug: Gemcitabine/ clindamycin
Comparison of saline solution rinse vs antibiotic rinse
Comparison of saline solution rinse vs antibiotic rinse
Surgical Site Infection
Number of participants with Surgical Site Infections
Time frame: 30 days
Incidence of SSI Requiring Intervention
Number of participants with SSI requiring reoperation or other procedural intervention at 30 days.
Time frame: 30 days
| Milestone | Saline Irrigation | Antibiotic Irrigation |
|---|---|---|
| Started | 124 | 126 |
| Completed | 121 | 120 |
| Not completed | 3 | 6 |
Number of participants with Surgical Site Infections
| Participants | Saline Irrigation | Antibiotic Irrigation |
|---|---|---|
| Surgical Site Infection | 11 | 10 |
Number of participants with SSI requiring reoperation or other procedural intervention at 30 days.
| Participants | Saline Irrigation | Antibiotic Irrigation |
|---|---|---|
| Incidence of SSI Requiring Intervention | 8 | 8 |
Collected over 90 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Saline Irrigation | 1/124 (0.8%) | 9/124 (7.3%) | 13/124 (10.5%) |
| Antibiotic Irrigation | 3/126 (2.4%) | 5/126 (4%) | 7/126 (5.6%) |
| Event | Saline Irrigation | Antibiotic Irrigation |
|---|---|---|
| respiratory insufficiencyRespiratory, thoracic and mediastinal disorders | 1/124 | 3/126 |
| hematomaBlood and lymphatic system disorders | 2/124 | 0/126 |
| bowel obstructionGastrointestinal disorders | 1/124 | 1/126 |
| alcohol withdrawalInjury, poisoning and procedural complications | 1/124 | 0/126 |
| ascitesGastrointestinal disorders | 1/124 | 0/126 |
| wound infectionInfections and infestations | 1/124 | 0/126 |
| lethargyGeneral disorders | 1/124 | 0/126 |
| LeukocytosisBlood and lymphatic system disorders | 1/124 | 0/126 |
| pneumoniaRespiratory, thoracic and mediastinal disorders | 0/124 | 1/126 |
| Event | Saline Irrigation | Antibiotic Irrigation |
|---|---|---|
| ileusGastrointestinal disorders | 13/124 | 7/126 |
| Age, Categorical(Participants) | Saline Irrigation | Antibiotic Irrigation | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 58 | 69 | 127 |
| >=65 years | 66 | 57 | 123 |
| Sex: Female, Male(Participants) | Saline Irrigation | Antibiotic Irrigation | Total |
|---|---|---|---|
| Female | 74 | 61 | 135 |
| Male | 50 | 65 | 115 |
| Race and Ethnicity Not Collected(Participants) | Saline Irrigation | Antibiotic Irrigation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Plan to share: No — There will be no patient information shared
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Prisma Health-Upstate