Cleancision IntRaoperative Contamination prEvention Study
- Conditions
- Wound ContaminationColorectal Surgery
- Interventions
- Device: CleanCision
- Registration Number
- NCT02413879
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group CleanCision All study subjects will be treated using the CleanCision device.
- Primary Outcome Measures
Name Time Method Efficacy (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) Comparison of enteric bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
Safety (Serious Adverse Events Directly Attributable to the Device) 30 days Incidence of Serious Adverse Events directly attributable to the device
- Secondary Outcome Measures
Name Time Method Efficacy (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) Comparison of bacterial contamination on the exposed surface of the CleanCision sheath compared to the protected incision edge
Trial Locations
- Locations (7)
Stony Brook Medicine
🇺🇸Stony Brook, New York, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Washington University Medical Center
🇺🇸Saint Louis, Missouri, United States
Lahey Hospital and Medical Center
🇺🇸Burlington, Massachusetts, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Intermountain Healthcare McKay-Dee Hospital
🇺🇸Ogden, Utah, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States