N/A
Completed N=702
Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery
Colorectal Surgery
Source: ClinicalTrials.gov NCT03816995 ↗
Enrolled (actual)
702
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Surgical Site Infection (SSI) Rate — 16; 14; 6; 1 Participants
Summary
Surgical site infection (SSI) remains a problem in colorectal surgery. Strategies to reduce the incidence of SSI following colorectal surgery are important to improve overall patient outcomes, reduce healthcare-associated costs and provide value-based healthcare to surgical patients.
Preventing contamination of the wound through the use of barrier wound protectors or intraoperative wound irrigation has shown significant promise individually and is an ongoing focus to reduce wound infections SSI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgical Site Infection (SSI) Rate |
16; 14; 6; 1; 6; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients 18 years old and above.
- Elective colorectal surgery with a planned resection including open or laparoscopic surgeries.
- Clean -contaminated, contaminated and dirty wounds per the definition above.
- Patients undergoing Standard of care SSI reduction bundle including Prophylactic AB and mechanical bowel preparation.
- Anticipated incision length of 3-17 cm
Exclusion Criteria
- Patients younger than 18 years old.
- Patients with a preexisting stoma.
- Patients with prior laparotomy within 15 days.
- Patients with an active infection or systemic antibiotic therapy within 1 week prior to surgery with the exception of preoperative antimicrobial prophylaxis.
- Emergent/ urgent surgery.
Data sourced from ClinicalTrials.gov (NCT03816995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.