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Cleancision IntRaoperative Contamination prEvention Study (CIRCE)

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ClinicalTrials.gov Identifier: NCT02413879
Recruitment Status : Completed
First Posted : April 10, 2015
Results First Posted : July 13, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Prescient Surgical

Brief 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.

Condition or disease Intervention/treatment
Wound Contamination Colorectal Surgery 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  (Clinical Trial)
Actual Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : March 2015
Primary Completion Date : July 2016
Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) [ Time Frame: 1 day (end of the procedure and removal of the investigational device) ]
    Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge

  2. Safety (Serious Adverse Events Directly Attributable to the Device) [ Time Frame: 30 days ]
    Incidence of Serious Adverse Events directly attributable to the device


Secondary Outcome Measures :
  1. Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge) [ Time Frame: 1 day (end of the procedure and removal of the investigational device) ]
    Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02413879


Locations
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Missouri
Washington University Medical Center
Saint Louis, Missouri, United States, 63110
United States, New York
Stony Brook Medicine
Stony Brook, New York, United States, 11794
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Scott & White Memorial Hospital
Temple, Texas, United States, 76508
United States, Utah
Intermountain Healthcare McKay-Dee Hospital
Ogden, Utah, United States, 84403
Sponsors and Collaborators
Prescient Surgical
Investigators
Principal Investigator: Harry Papaconstantinou, MD Scott & White Memorial Hospital

Responsible Party: Prescient Surgical
ClinicalTrials.gov Identifier: NCT02413879     History of Changes
Other Study ID Numbers: CLP-0001
First Posted: April 10, 2015    Key Record Dates
Results First Posted: July 13, 2017
Last Update Posted: July 27, 2017
Last Verified: July 2017