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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02413879
Other study ID # CLP-0001
Secondary ID
Status Completed
Phase N/A
First received March 27, 2015
Last updated July 26, 2017
Start date March 2015
Est. completion date July 2016

Study information

Verified date July 2017
Source Prescient Surgical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
CleanCision
Wound protection during colorectal surgery.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Prescient Surgical

Country where clinical trial is conducted

United States, 

Outcome

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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