NCT02413879

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: Prescient Surgical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Wound Contamination
• Colorectal Surgery

Interventions

Type	Name	Description
DEVICE	CleanCision	Wound protection during colorectal surgery.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-04-10
• Last updated: 2017-07-27
• Results posted: 2017-07-13

Locations

7 sites across 1 country: United States