MedTrace Logo

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

NCT03816995 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 702

Last updated 2025-08-06

Study results available
· View outcomes & findings →

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.

Conditions

  • Colorectal Surgery

Interventions

DEVICE

CleanCision Wound Retraction and Protection System

wound retraction and irrigation

DEVICE

Alexis O Wound Protector

wound retraction

Sponsors & Collaborators

  • Prescient Surgical

    collaborator INDUSTRY

  • Scott Steele

    lead OTHER

Principal Investigators

  • Scott Steele, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2023-08-18
Completion
2023-08-18
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03816995 on ClinicalTrials.gov