NCT02413879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1 year until next milestone

Results Posted

Study results publicly available

July 13, 2017

Completed
Last Updated

July 27, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

March 27, 2015

Results QC Date

June 16, 2017

Last Update Submit

July 26, 2017

Conditions

Wound ContaminationColorectal Surgery

Outcome Measures

Primary Outcomes (2)

  • 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)

  • Safety (Serious Adverse Events Directly Attributable to the Device)

    Incidence of Serious Adverse Events directly attributable to the device

    30 days

Secondary Outcomes (1)

  • 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)

Study Arms (1)

Treatment Group

EXPERIMENTAL

All study subjects will be treated using the CleanCision device.

Device: CleanCision

Interventions

CleanCisionDEVICE

Wound protection during colorectal surgery.

Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Scott & White Memorial Hospital

Temple, Texas, 76508, United States

Location

Intermountain Healthcare McKay-Dee Hospital

Ogden, Utah, 84403, United States

Location

Related Publications (1)

  • 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.

    PMID: 29523908DERIVED

Results Point of Contact

Title
Director of Clinical
Organization
Prescient Surgical
lclaude@prescientsurgical.com
6504895025

Study Officials

  • Harry Papaconstantinou, MD

    Scott & White Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 10, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 27, 2017

Results First Posted

July 13, 2017

Record last verified: 2017-07

Locations

US(7)