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

Not Applicable

Completed

• Conditions: Colorectal Surgery

• Registration Number: NCT03816995
• Lead Sponsor: Scott Steele

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 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.

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 significant increase in morbidity, length of hospital stay, readmissions and healthcare-associated cost. Therefore, 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.

Key to the pathogenesis of SSI is the degree of bacterial contamination of the surgical wound. Preventing contamination of the wound or reducing the bacterial load through the use of barrier wound protectors or intraoperative wound irrigation has shown significant promise individually and is an ongoing strategic focus to reduce wound infections after surgery.

The usage of intraoperative wound irrigation has been shown to significantly reduce the risk of SSI via multiple RTC. A surgical device that combines continuous wound irrigation and barrier protection will have an important SSI prevention advantage.

CleanCision is a recently developed apparatus that serves this purpose and was found to reduce bacterial wound contamination in preclinical and clinical trials.

This study aims to investigate the effect of using CleanCision wound protector on the rates of postoperative Surgical Site Infections in comparison to the current wound protector (Alexis O) being used at our institute.

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-24
• Study First Posted: 2019-01-25
• Study Start: 2019-02-12
• Primary Completion: 2023-08-18
• Study Completion: 2023-08-18
• Status Verified: 2025-07
• Results First Submitted: 2025-07-21
• Results First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Results First Posted: 2025-08-06
• Last Update Posted: 2025-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 702

Inclusion Criteria

1. Patients 18 years old and above.
2. Elective colorectal surgery with a planned resection including open or laparoscopic surgeries.
3. Clean -contaminated, contaminated and dirty wounds per the definition above.
4. Patients undergoing Standard of care SSI reduction bundle including Prophylactic AB and mechanical bowel preparation.
5. Anticipated incision length of 3-17 cm

Exclusion Criteria

1. Patients younger than 18 years old.
2. Patients with a preexisting stoma.
3. Patients with prior laparotomy within 15 days.
4. Patients with an active infection or systemic antibiotic therapy within 1 week prior to surgery with the exception of preoperative antimicrobial prophylaxis.
5. Emergent/ urgent surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Surgical Site Infection (SSI) Rate	30 days	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.

Trial Locations

Locations (1)

Cleveland Clinic Main Campus; 🇺🇸 Cleveland, Ohio, United States