Cleancision IntRaoperative Contamination prEvention Study

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

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.

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.

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