Cleancision IntRaoperative Contamination prEvention Study

Colorectal Surgery Clinical Trial

— CIRCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413879
• Other study ID #: CLP-0001
• Status: Completed
• Phase: N/A
• First received: March 27, 2015
• Last updated: July 26, 2017
• Start date: March 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2017
• Source: Prescient Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Surgery
• Wound Contamination

Intervention

Device:
• CleanCision
Wound protection during colorectal surgery.

Locations

Country	Name	City	State
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Baylor University Medical Center	Dallas	Texas
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Intermountain Healthcare McKay-Dee Hospital	Ogden	Utah
United States	Washington University Medical Center	Saint Louis	Missouri
United States	Stony Brook Medicine	Stony Brook	New York
United States	Scott & White Memorial Hospital	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Prescient Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Safety (Serious Adverse Events Directly Attributable to the Device)	Incidence of Serious Adverse Events directly attributable to the device	30 days
Secondary	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)