Peri-Strips Dry (PSD) Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

April 4, 2017 updated by: Baxter Healthcare Corporation

Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement for Colorectal Surgery

Purpose of the study is to assess the utility of PSD Veritas as a staple line reinforcement to minimize the risk of leakage during or after colo-rectal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study is designed as a prospective enrollment of patients undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis. Patients who are scheduled for elective resection of the left, anterior and low anterior colon can be enrolled in the study.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Minnesota
      • St. Paul, Minnesota, United States, 55105
        • Colon & Rectal Surgery Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient must comply with follow-up evaluations
  • Patient or representative must provide informed consent prior to enrollment
  • Patient scheduled for elective surgical excision of the left, anterior or low anterior colon
  • Patient must meet all criteria and be eligible to have open or laparoscopic colorectal surgery with primary anastomosis at one location

Exclusion Criteria:

  • Crohns disease
  • Emergency colorectal surgery for trauma, obstruction, ischemic bowel, perforated diverticulum and all other emergent diagnosis.
  • Patients who have not had mechanical bowel preparation
  • Patients with known documented sensitivity/allergy to bovine material
  • Severe radiation damage to tissue
  • Carcinomatosis or stage IV cancer
  • BMI is 35 or greater
  • Cancer at primary anastomosis site that cannot be excised
  • Patients who require an ileo rectal anastomosis
  • Surgery anticipated to include jejunostomy pouch
  • Anticipated diverting stoma
  • No anti adhesive barrier can be used around anastomotic site
  • No multiple circular anastomosis
  • Surgeons discretion to exclude any patient he/she feels would not have a safe anastomosis
  • Patient life expectacny less than follow-up timeframe of study
  • Pregnancy
  • Patients currently enrolled in a study that competes for the same patient population

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
PSD Veritas Collagen Matrix Reinforcement Arm
Device: Staple line reinforcement
Placement of reinforcement material on circular anastomotic staple line for prevention of leak during and post surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage.
Time Frame: Discharge and 1 Month post surgery
Discharge and 1 Month post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Collaborators

Synovis Surgical Innovations

Investigators

  • Principal Investigator: Richard Karulf, MD, Colon & Rectal Surgery Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

November 14, 2007

First Submitted That Met QC Criteria

November 15, 2007

First Posted (Estimate)

November 16, 2007

Study Record Updates

Last Update Posted (Actual)

May 10, 2017

Last Update Submitted That Met QC Criteria

April 4, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP1011, Rev C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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