Clinical trial NCT03816995: A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery
Official title: A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colorectal Surgery
Keywords: wound irrigation
cleancision
colorectal surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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. Patiens 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.

Primary outcomes:
measure: Surgical Site Infection rate
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Scott Steele, MD
role: PRINCIPAL_INVESTIGATOR
References:
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