Cleancision IntRaoperative Contamination prEvention Study (CIRCE)

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Surgery; Wound Contamination
• Intervention / Treatment: Device: CleanCision

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.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Clinic Foundation
  • Massachusetts
    • Burlington, Massachusetts, United States, 01805
      • Lahey Hospital and Medical Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University Medical Center
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook Medicine
  • Texas
    • Dallas, Texas, United States, 75246
      • Baylor University Medical Center
    • Temple, Texas, United States, 76508
      • Scott & White Memorial Hospital
  • Utah
    • Ogden, Utah, United States, 84403
      • Intermountain Healthcare McKay-Dee Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Group; All study subjects will be treated using the CleanCision device.	Device: CleanCision; Wound protection during colorectal surgery.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Prescient Surgical
• Investigators: Principal Investigator: Harry Papaconstantinou, MD, Scott & White Memorial Hospital

Publications and helpful links

General Publications

• Papaconstantinou HT, Ricciardi R, Margolin DA, Bergamaschi R, Moesinger RC, Lichliter WE, Birnbaum EH. A Novel Wound Retractor Combining Continuous Irrigation and Barrier Protection Reduces Incisional Contamination in Colorectal Surgery. World J Surg. 2018 Sep;42(9):3000-3007. doi: 10.1007/s00268-018-4568-z.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 27, 2015
• First Submitted That Met QC Criteria: April 9, 2015
• First Posted (Estimate): April 10, 2015

Study Record Updates

• Last Update Posted (Actual): July 27, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CLP-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No