Cleancision IntRaoperative Contamination prEvention Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-07-31

Brief Summary

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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 contamination at the wound incision site when the CleanCision is used during surgery.

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Detailed Description

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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.

Conditions

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Wound Contamination Colorectal Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Treatment Group

All study subjects will be treated using the CleanCision device.

Group Type EXPERIMENTAL

CleanCision

Intervention Type DEVICE

Wound protection during colorectal surgery.

Interventions

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CleanCision

Wound protection during colorectal surgery.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No