Colorectal Surgery Clinical Trial
— CIRCEOfficial 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
Verified date | July 2017 |
Source | Prescient Surgical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Prescient Surgical |
United States,
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) |
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