Ventral Hernia Repair
Conditions
Keywords
Infection, hernia repair
Brief 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)
Detailed description
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.
Interventions
DRUGGemcitabine/ clindamycin
Comparison of saline solution rinse vs antibiotic rinse
DRUGNormal saline
Comparison of saline solution rinse vs antibiotic rinse
Sponsors
The Cleveland Clinic
Penn State University
Oregon Health and Science University
Prisma Health-Upstate
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Site Infection | 30 days | Number of participants with Surgical Site Infections |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of SSI Requiring Intervention | 30 days | Number of participants with SSI requiring reoperation or other procedural intervention at 30 days. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline Irrigation 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.
Normal saline: Comparison of saline solution rinse vs antibiotic rinse | 124 |
| Antibiotic Irrigation 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.
Gemcitabine/ clindamycin: Comparison of saline solution rinse vs antibiotic rinse | 126 |
| Total | 250 |
Baseline characteristics
| Characteristic | Saline Irrigation | Antibiotic Irrigation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 66 Participants | 57 Participants | 123 Participants |
| Age, Categorical Between 18 and 65 years | 58 Participants | 69 Participants | 127 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 74 Participants | 61 Participants | 135 Participants |
| Sex: Female, Male Male | 50 Participants | 65 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 124 | 3 / 126 |
| other Total, other adverse events | 13 / 124 | 7 / 126 |
| serious Total, serious adverse events | 9 / 124 | 5 / 126 |
Outcome results
Primary
Surgical Site Infection
Number of participants with Surgical Site Infections
Time frame: 30 days
Population: 111 subjects in the saline group reached the 30 day visit. 110 subjects in the antibiotic group reached the 30 day visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saline Irrigation | Surgical Site Infection | 11 Participants |
| Antibiotic Irrigation | Surgical Site Infection | 10 Participants |
Secondary
Incidence of SSI Requiring Intervention
Number of participants with SSI requiring reoperation or other procedural intervention at 30 days.
Time frame: 30 days
Population: 111 subjects in the saline group reached the 30 day visit. 110 subjects in the antibiotic group reached the 30 day visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saline Irrigation | Incidence of SSI Requiring Intervention | 8 Participants |
| Antibiotic Irrigation | Incidence of SSI Requiring Intervention | 8 Participants |