Cleancision IntRaoperative Contamination prEvention Study

Completed · Not applicable

Conditions studied: Wound Contamination, Colorectal Surgery

In brief

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.

Key facts

Study ID

NCT02413879

Run by

Prescient Surgical

People needed

108

Starts

2015-03-01

Expected to finish

2016-07-01

Last updated by the study team

2017-07-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.