CompletedNot Applicable

Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery

United States702 participantsStarted 2019-02-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Surgical Site Infection (SSI) Rate

Timeframe: 30 days

Trial details

NCT IDNCT03816995

SponsorScott Steele

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-18

Results submitted2025-07-21

View on ClinicalTrials.gov More Colorectal Surgery trials