Cleancision IntRaoperative Contamination prEvention Study

Study Overview
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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.

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.

Official Title
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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

Conditions
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Wound Contamination, Colorectal Surgery

Intervention / Treatment
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* Device: CleanCision


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>All study subjects will be treated using the CleanCision device. | Device: CleanCision<br>* Wound protection during colorectal surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day (end of the procedure and removal of the investigational device) |