Trial Outcomes & Findings for Reducing INfection at the Surgical SitE With Antibiotic Irrigation During Ventral Hernia Repair (RINSE Trial) (NCT NCT03945357)
NCT ID: NCT03945357
Last Updated: 2023-08-24
Results Overview
Number of participants with Surgical Site Infections
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
250 participants
Primary outcome timeframe
30 days
Results posted on
2023-08-24
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
126
|
|
Overall Study
COMPLETED
|
121
|
120
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Saline Irrigation
n=124 Participants
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
|
Antibiotic Irrigation
n=126 Participants
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
|
Total
n=250 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=124 Participants
|
0 Participants
n=126 Participants
|
0 Participants
n=250 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
58 Participants
n=124 Participants
|
69 Participants
n=126 Participants
|
127 Participants
n=250 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=124 Participants
|
57 Participants
n=126 Participants
|
123 Participants
n=250 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=124 Participants
|
61 Participants
n=126 Participants
|
135 Participants
n=250 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=124 Participants
|
65 Participants
n=126 Participants
|
115 Participants
n=250 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 30 daysPopulation: 111 subjects in the saline group reached the 30 day visit. 110 subjects in the antibiotic group reached the 30 day visit.
Number of participants with Surgical Site Infections
Outcome measures
| Measure |
Saline Irrigation
n=111 Participants
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
|
Antibiotic Irrigation
n=110 Participants
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
|
|---|---|---|
|
Surgical Site Infection
|
11 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: 111 subjects in the saline group reached the 30 day visit. 110 subjects in the antibiotic group reached the 30 day visit.
Number of participants with SSI requiring reoperation or other procedural intervention at 30 days.
Outcome measures
| Measure |
Saline Irrigation
n=111 Participants
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
|
Antibiotic Irrigation
n=110 Participants
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
|
|---|---|---|
|
Incidence of SSI Requiring Intervention
|
8 Participants
|
8 Participants
|
Adverse Events
Saline Irrigation
Serious events: 9 serious events
Other events: 13 other events
Deaths: 1 deaths
Antibiotic Irrigation
Serious events: 5 serious events
Other events: 7 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Saline Irrigation
n=124 participants at risk
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
|
Antibiotic Irrigation
n=126 participants at risk
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
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.81%
1/124 • 90 days
|
0.00%
0/126 • 90 days
|
|
Gastrointestinal disorders
bowel obstruction
|
0.81%
1/124 • 90 days
|
0.79%
1/126 • 90 days
|
|
Blood and lymphatic system disorders
hematoma
|
1.6%
2/124 • 90 days
|
0.00%
0/126 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
respiratory insufficiency
|
0.81%
1/124 • 90 days
|
2.4%
3/126 • 90 days
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/124 • 90 days
|
0.79%
1/126 • 90 days
|
|
Injury, poisoning and procedural complications
alcohol withdrawal
|
0.81%
1/124 • 90 days
|
0.00%
0/126 • 90 days
|
|
Gastrointestinal disorders
ascites
|
0.81%
1/124 • 90 days
|
0.00%
0/126 • 90 days
|
|
Infections and infestations
wound infection
|
0.81%
1/124 • 90 days
|
0.00%
0/126 • 90 days
|
|
General disorders
lethargy
|
0.81%
1/124 • 90 days
|
0.00%
0/126 • 90 days
|
Other adverse events
| Measure |
Saline Irrigation
n=124 participants at risk
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
|
Antibiotic Irrigation
n=126 participants at risk
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
|
|---|---|---|
|
Gastrointestinal disorders
ileus
|
10.5%
13/124 • 90 days
|
5.6%
7/126 • 90 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place