Cleancision IntRaoperative Contamination prEvention Study (CIRCE)

Prescient Surgical

Status

Completed

Conditions

Wound Contamination

Colorectal Surgery

Treatments

Device: CleanCision

Study type

Interventional

Funder types

Industry

Identifiers

NCT02413879

CLP-0001

Details and patient eligibility

About

Full description

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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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