A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination and Surgical Site Infection in Colorectal Surgery

January 26, 2024 updated by: Scott Steele

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

702

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Main Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alexis O Wound Protector
Participants will undergo standard surgical procedure using the Alexis O wound protector.
Device: Alexis O Wound Protector
wound retraction
Experimental: CleanCision Wound Protector
Participants will undergo standard surgical procedure using the CleanCision Wound Retraction and Protection System
Device: CleanCision Wound Retraction and Protection System
wound retraction and irrigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection rate
Time Frame: 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.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scott Steele

Investigators

  • Principal Investigator: Scott Steele, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2019

Primary Completion (Actual)

September 23, 2023

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 24, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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