Trial Outcomes & Findings for Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery (NCT NCT03816995)
NCT ID: NCT03816995
Last Updated: 2025-08-06
Results Overview
To evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision continuous irrigation wound protector.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
702 participants
Primary outcome timeframe
30 days
Results posted on
2025-08-06
Participant Flow
Participant milestones
| Measure |
Alexis O Wound Protector
Participants will undergo standard surgical procedure using the Alexis O wound protector.
Alexis O Wound Protector: wound retraction
|
CleanCision Wound Protector
Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
CleanCision Wound Retraction and Protection System: wound retraction and irrigation
|
|---|---|---|
|
Overall Study
STARTED
|
351
|
351
|
|
Overall Study
COMPLETED
|
327
|
318
|
|
Overall Study
NOT COMPLETED
|
24
|
33
|
Reasons for withdrawal
| Measure |
Alexis O Wound Protector
Participants will undergo standard surgical procedure using the Alexis O wound protector.
Alexis O Wound Protector: wound retraction
|
CleanCision Wound Protector
Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
CleanCision Wound Retraction and Protection System: wound retraction and irrigation
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
1
|
|
Overall Study
Cancelled Surgery
|
8
|
12
|
|
Overall Study
No wound protector used
|
11
|
17
|
|
Overall Study
Protocol Violation
|
2
|
3
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Alexis O Wound Protector
n=327 Participants
Participants will undergo standard surgical procedure using the Alexis O wound protector.
Alexis O Wound Protector: wound retraction
|
CleanCision Wound Protector
n=318 Participants
Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
CleanCision Wound Retraction and Protection System: wound retraction and irrigation
|
Total
n=645 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 15.3 • n=327 Participants
|
57.2 years
STANDARD_DEVIATION 14.9 • n=318 Participants
|
57.7 years
STANDARD_DEVIATION 16.05 • n=645 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=327 Participants
|
187 Participants
n=318 Participants
|
355 Participants
n=645 Participants
|
|
Sex: Female, Male
Male
|
159 Participants
n=327 Participants
|
131 Participants
n=318 Participants
|
290 Participants
n=645 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
327 participants
n=327 Participants
|
318 participants
n=318 Participants
|
645 participants
n=645 Participants
|
PRIMARY outcome
Timeframe: 30 daysTo evaluate the 30 day post-operative SSI rate in patients undergoing elective colorectal surgical procedures after intraoperative usage of Alexis O wound protector vs. CleanCision continuous irrigation wound protector.
Outcome measures
| Measure |
Alexis O Wound Protector
n=327 Participants
Participants will undergo standard surgical procedure using the Alexis O wound protector.
Alexis O Wound Protector: wound retraction
|
CleanCision Wound Protector
n=318 Participants
Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
CleanCision Wound Retraction and Protection System: wound retraction and irrigation
|
|---|---|---|
|
Surgical Site Infection (SSI) Rate
Post-op Superficial SSI
|
16 Participants
|
14 Participants
|
|
Surgical Site Infection (SSI) Rate
Post-op Deep SSI
|
6 Participants
|
1 Participants
|
|
Surgical Site Infection (SSI) Rate
Post-op Organ/Space SSI
|
6 Participants
|
3 Participants
|
|
Surgical Site Infection (SSI) Rate
Composite Infection (SSIs + Wound Disruption)
|
28 Participants
|
18 Participants
|
Adverse Events
Alexis O Wound Protector
Serious events: 0 serious events
Other events: 98 other events
Deaths: 1 deaths
CleanCision Wound Protector
Serious events: 0 serious events
Other events: 95 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alexis O Wound Protector
n=327 participants at risk
Participants will undergo standard surgical procedure using the Alexis O wound protector.
Alexis O Wound Protector: wound retraction
|
CleanCision Wound Protector
n=318 participants at risk
Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
CleanCision Wound Retraction and Protection System: wound retraction and irrigation
|
|---|---|---|
|
Infections and infestations
Post-Op Sepsis
|
1.2%
4/327 • Number of events 4 • 30 days following surgery
|
0.63%
2/318 • Number of events 2 • 30 days following surgery
|
|
Infections and infestations
Post-Op Pneumonia
|
0.61%
2/327 • Number of events 2 • 30 days following surgery
|
1.3%
4/318 • Number of events 4 • 30 days following surgery
|
|
General disorders
Post-Op Unplanned Intubation
|
0.61%
2/327 • Number of events 2 • 30 days following surgery
|
0.00%
0/318 • 30 days following surgery
|
|
Vascular disorders
Post-Op Deep Vein Thrombosis
|
0.92%
3/327 • Number of events 3 • 30 days following surgery
|
0.63%
2/318 • Number of events 2 • 30 days following surgery
|
|
Vascular disorders
Post-Op Pulmonary Embolism
|
0.00%
0/327 • 30 days following surgery
|
0.31%
1/318 • Number of events 1 • 30 days following surgery
|
|
Renal and urinary disorders
Post-Op Acute Renal Failure
|
0.31%
1/327 • Number of events 1 • 30 days following surgery
|
1.9%
6/318 • Number of events 6 • 30 days following surgery
|
|
Gastrointestinal disorders
Post-Op Anastomotic Leak
|
0.31%
1/327 • Number of events 1 • 30 days following surgery
|
0.00%
0/318 • 30 days following surgery
|
|
Infections and infestations
Post-Op C.Diff
|
1.2%
4/327 • Number of events 4 • 30 days following surgery
|
0.94%
3/318 • Number of events 3 • 30 days following surgery
|
|
Gastrointestinal disorders
Post-Op Ileus
|
9.5%
31/327 • Number of events 31 • 30 days following surgery
|
8.2%
26/318 • Number of events 26 • 30 days following surgery
|
|
General disorders
Unplanned Reoperation
|
2.1%
7/327 • Number of events 7 • 30 days following surgery
|
2.2%
7/318 • Number of events 7 • 30 days following surgery
|
|
Social circumstances
Readmission
|
11.6%
38/327 • Number of events 38 • 30 days following surgery
|
11.3%
36/318 • Number of events 36 • 30 days following surgery
|
|
Renal and urinary disorders
Post-Op Urinary Tract Infection
|
1.5%
5/327 • Number of events 5 • 30 days following surgery
|
2.5%
8/318 • Number of events 8 • 30 days following surgery
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place