Status:
COMPLETED
Prospective, Randomized, Parallel-arm Clinical Trial of CleanCision or Alexis O in Elective Colorectal Surgery
Lead Sponsor:
Scott Steele
Collaborating Sponsors:
Prescient Surgical
Conditions:
Colorectal Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Surgical site infection (SSI) remains a persistent and morbid problem in colorectal surgery with published rates ranging from 7 to 25%. The negative outcomes of SSI are well reported and include a sig...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 18 2023
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT03816995
Start Date
February 12 2019
End Date
August 18 2023
Last Update
August 6 2025
Active Locations (1)
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1
Cleveland Clinic Main Campus
Cleveland, Ohio, United States, 44195