Ventral Hernia RepairPhase 3RINSENCT03945357
Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
A Phase 3 study testing Gemcitabine/ clindamycin and Normal saline in people with Ventral Hernia Repair, run by Prisma Health-Upstate at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia Repair
- What is being tested?
- Gemcitabine/ clindamycin and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2019to 9 Jan 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 y/o.
- Elective, open ventral hernia repair in a retromuscular fashion, with or without TAR.
- Clean, clean-contaminated, or contaminated wounds.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health Upstate
Greenville, South Carolina, 29615
About this study
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)
Read the 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.
- Conditions
- Ventral Hernia Repair
- Being tested
- Gemcitabine/ clindamycin, Normal saline
- Keywords
- Infection, hernia repair
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine/ clindamycinDrug
Comparison of saline solution rinse vs antibiotic rinse
Normal salineDrug
Comparison of saline solution rinse vs antibiotic rinse
| Study group | Role | What they receive |
|---|---|---|
| Saline Irrigation | Active comparator | 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. Receives: Drug: Normal saline |
| Antibiotic Irrigation | Active comparator | 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. Receives: Drug: Gemcitabine/ clindamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical Site Infection
Number of participants with Surgical Site Infections
Measured: 30 days
Secondary outcomes (1)
Incidence of SSI Requiring Intervention
Number of participants with SSI requiring reoperation or other procedural intervention at 30 days.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start15 May 2019
- Primary completion9 Jan 2023
- Study completion9 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ventral Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Warren, MD, Principal investigator, Prisma Health-Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03945357
- Sponsor's protocol ID
- Pro00087360
- Acronym
- RINSE
- Status last verified
- Aug 2023
- First submitted
- 8 May 2019
- Last updated
- 24 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There will be no patient information shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial)
- ClinicalTrials.gov ID
- NCT03945357
- Acronym / sponsor ID
- RINSE / Pro00087360
- Conditions
- Ventral Hernia Repair
- Keywords
- Infection, hernia repair
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- The Cleveland Clinic, Penn State University, Oregon Health and Science University
- Study start
- 15 May 2019 (actual)
- Primary completion
- 9 Jan 2023 (actual)
- Study completion
- 9 Jan 2023 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Posted 24 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Saline Irrigation | Active comparator | Drug: Normal salineNormal 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. |
| Antibiotic Irrigation | Active comparator | Drug: Gemcitabine/ clindamycinAntibiotic 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 y/o.
- Elective, open ventral hernia repair in a retromuscular fashion, with or without TAR.
- Clean, clean-contaminated, or contaminated wounds.
Key exclusion criteria (7 listed)
- Age <18 y/o.
- Pregnancy.
- Emergency hernia repair.
- Laparoscopic, robotic, or hybrid approach.
- Dirty wounds.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gemcitabine/ clindamycinComparison of saline solution rinse vs antibiotic rinse | Drug | Antibiotic Irrigation |
| Normal salineComparison of saline solution rinse vs antibiotic rinse | Drug | Saline Irrigation |
Primary outcome
Surgical Site Infection
Time frame: 30 days
Number of participants with Surgical Site Infections
1 secondary outcome
Incidence of SSI Requiring Intervention
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There will be no patient information shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Warren, MD principal investigator
Prisma Health-Upstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gemcitabine/ clindamycin and Normal saline in people with Ventral Hernia Repair, run by Prisma Health-Upstate at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical Site Infection (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.