Trial Outcomes & Findings for Randomized Trial Comparing Irrisept to Saline Irrigation for Infection Prevention (NCT NCT05402995)
NCT ID: NCT05402995
Last Updated: 2024-04-24
Results Overview
Measured by the number of surgical site infections in the total population of patients.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
6 participants
Primary outcome timeframe
90 days
Results posted on
2024-04-24
Participant Flow
Participant milestones
| Measure |
Standard Operative Debridement and Spanning External Fixator (Reference/Control Group)
This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.
Saline: Saline irrigation
|
Spanning External Fixator With Irrisept Irrigation (Treatment Group 1)
Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2)
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Saline: Saline irrigation
|
Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3)
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
Standard Operative Debridement and Spanning External Fixator (Reference/Control Group)
This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.
Saline: Saline irrigation
|
Spanning External Fixator With Irrisept Irrigation (Treatment Group 1)
Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2)
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Saline: Saline irrigation
|
Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3)
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
|---|---|---|---|---|
|
Overall Study
Study terminated due to lack of enrollment and followup.
|
0
|
2
|
2
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Operative Debridement and Spanning External Fixator (Reference/Control Group)
This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.
Saline: Saline irrigation
|
Spanning External Fixator With Irrisept Irrigation (Treatment Group 1)
n=2 Participants
Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2)
n=2 Participants
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Saline: Saline irrigation
|
Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3)
n=2 Participants
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=6 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
1 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
1 Participants
n=2 Participants
|
5 Participants
n=6 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
—
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group.
Measured by the number of surgical site infections in the total population of patients.
Outcome measures
| Measure |
Standard Operative Debridement and Spanning External Fixator (Reference/Control Group)
This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.
Saline: Saline irrigation
|
Spanning External Fixator With Irrisept Irrigation (Treatment Group 1)
n=2 Participants
Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2)
n=2 Participants
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Saline: Saline irrigation
|
Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3)
n=2 Participants
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
|---|---|---|---|---|
|
Number of Participants Experiencing Surgical Site Infection (SSI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: As study was terminated due to difficulty enrolling participants there was no one randomized to the reference/control group. Unable to measure presence or absence of fracture callus due to lack of follow-up with study termination.
Presence or absence of fracture callous measured on x-ray by an experienced orthopaedic surgeon.
Outcome measures
Outcome data not reported
Adverse Events
Standard Operative Debridement and Spanning External Fixator (Reference/Control Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Spanning External Fixator With Irrisept Irrigation (Treatment Group 1)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Operative Debridement and Spanning External Fixator (Reference/Control Group)
This is the standard of care management. Patient will go to the operating room (OR) first for irrigation and debridement with normal saline and external fixation. Will return to OR at a later date for definitive fixation.
Saline: Saline irrigation
|
Spanning External Fixator With Irrisept Irrigation (Treatment Group 1)
n=2 participants at risk
Patient will go to the operating room (OR) first for irrigation and debridement with Irrisept (the experimental irrigation solution) and external fixation. Will return to OR at a later date for definitive fixation.
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
Antibiotic-coated Medullary Nail With Saline Irrigation (Treatment Group 2)
n=2 participants at risk
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with normal saline.
Saline: Saline irrigation
|
Antibiotic-coated Medullary Nail With Irrisept Irrigation (Treatment Group 3)
n=2 participants at risk
Patient will go to the operating room (OR) for treatment with an antibiotic-coated nail and have irrigation and debridement with Irrisept (the experimental irrigation solution).
Irrisept (Irrigation Solution): Irrisept Antimicrobial Wound Lavage is intended for mechanical cleansing and removal of debris, dirt and foreign materials, including microorganisms from wounds.
|
|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Amputation
|
—
0/0 • 1 year
There is a minimal increased risk of reaction to chlorhexidine gluconate in the Irrisept treatment group which may include allergic reaction or irritation therefore adverse event / serious adverse events are not anticipated and would be considered a result of the injury sustained.
|
0.00%
0/2 • 1 year
There is a minimal increased risk of reaction to chlorhexidine gluconate in the Irrisept treatment group which may include allergic reaction or irritation therefore adverse event / serious adverse events are not anticipated and would be considered a result of the injury sustained.
|
50.0%
1/2 • Number of events 1 • 1 year
There is a minimal increased risk of reaction to chlorhexidine gluconate in the Irrisept treatment group which may include allergic reaction or irritation therefore adverse event / serious adverse events are not anticipated and would be considered a result of the injury sustained.
|
0.00%
0/2 • 1 year
There is a minimal increased risk of reaction to chlorhexidine gluconate in the Irrisept treatment group which may include allergic reaction or irritation therefore adverse event / serious adverse events are not anticipated and would be considered a result of the injury sustained.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place