Cleancision IntRaoperative Contamination prEvention Study



Status:Completed
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:7/28/2017
Start Date:March 2015
End Date:July 2016

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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

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.

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.

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
We found this trial at
7
sites
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Burlington, Massachusetts 01805
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Burlington, MA
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New Orleans, Louisiana 70121
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New Orleans, LA
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Ogden, UT
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Stony Brook, New York 11794
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Stony Brook, NY
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2401 S. 31st Street
Temple, Texas 76508
254-724-2111
Scott & White Memorial Hospital When Arthur C. Scott, MD, and Raleigh R. White Jr.,...
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Temple, TX
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