Clinical trial NCT02413879: Cleancision IntRaoperative Contamination prEvention Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Contamination
Colorectal Surgery
Lead sponsor: Prescient Surgical
Sponsor class: INDUSTRY
First posted: 2015-04-10
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Efficacy (Enteric Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
timeFrame: 1 day (end of the procedure and removal of the investigational device)
measure: Safety (Serious Adverse Events Directly Attributable to the Device)
timeFrame: 30 days
Secondary outcomes:
measure: Efficacy (Bacterial Contamination on the Exposed Surface of the CleanCision Sheath Compared to the Protected Incision Edge)
timeFrame: 1 day (end of the procedure and removal of the investigational device)
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University Medical Center
state: Missouri
city: Stony Brook
country: United States
facility: Stony Brook Medicine
state: New York
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Ogden
country: United States
facility: Intermountain Healthcare McKay-Dee Hospital
state: Utah
Study officials:
affiliation: Scott & White Memorial Hospital
name: Harry Papaconstantinou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.