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

Scott Steele

Status: Completed

Conditions: Colorectal Surgery

Treatments: Device: Alexis O Wound Protector; Device: CleanCision Wound Retraction and Protection System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03816995

18-1346

Details and patient eligibility

About

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.

Full 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.

Enrollment: 702 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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702 participants in 2 patient groups

Alexis O Wound Protector

Active Comparator group

Description:

Participants will undergo standard surgical procedure using the Alexis O wound protector.

Treatment:

Device: Alexis O Wound Protector

CleanCision Wound Protector

Experimental group

Description:

Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System

Treatment:

Device: CleanCision Wound Retraction and Protection System