Cleancision IntRaoperative Contamination prEvention Study

Prescient Surgical108 enrolled

Overview

This study entitled, An Evaluation of the Safety and Efficacy of the CleanCision Wound Retraction and Protection System in Protecting Surgical Incisions from Intraoperative Contamination When Used during Colorectal Surgery, is designed to evaluate bacterial contamination at the wound incision site when the CleanCision is used during surgery. The CleanCision is a surgical tool that is designed to be used for the primary purpose of protecting the wound from contamination that occurs to the incision site during surgery ultimately reducing the occurrence of Surgical Site Infections (SSI). This is a prospective, multi-center, single-arm (non-randomized) clinical study.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

108

Conditions

Wound Contamination Colorectal Surgery

Interventions

CleanCisionDEVICE

Wound protection during colorectal surgery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 and older * BMI 15-45, inclusive * Colorectal surgery patient, planned resection * Incision length meets labeling requirements * Written informed consent using the governing IRB approved form Exclusion Criteria: * Patients with a pre-existing stoma * Patients undergoing emergent colorectal surgery * Known history of contact hypersensitivity or allergy to device materials * Prior laparotomy or abdominal surgery within a timeframe that may present a safety risk or compromise study results * Active infection, sepsis or systemic antibiotic therapy within timeframe that may impact safety or study results * Active participation in any other clinical study of an experimental drug or device that may impact safety or study results * Postsurgical life expectancy is less than the study follow up period * Subject is pregnant or lactating * Subject is under incarceration * Subject considered to be inoperable following exploratory surgery

Locations (7)

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Washington University Medical Center

St Louis, Missouri, United States

Stony Brook Medicine

Stony Brook, New York, United States

Outcomes

Primary Outcomes

Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)

Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge

Time frame: 1 day (end of the procedure and removal of the investigational device)

Safety (Serious Adverse Events Directly Attributable to the Device)

Incidence of Serious Adverse Events directly attributable to the device

Time frame: 30 days

Secondary Outcomes

Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)

Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge

Time frame: 1 day (end of the procedure and removal of the investigational device)

Data from ClinicalTrials.gov

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