Clinical trial NCT00566943: Reinforcement of Surgical Staple Lines Using Peri-Strips Dry (PSD) With Veritas Collagen Matrix
Official title: Synovis Life Technologies, Inc., Peri-Strips Dry With Veritas Collagen Matrix Staple Line Reinforcement. The RESULTS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Staple Line Reinforcement, Buttress
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
Collaborators: name: Synovis Surgical Innovations
First posted: 2007-12-04
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to verify the performance of PSD Veritas to provide staple line protection during surgical procedures for obesity.

Detailed description: The purpose of the study is to verify the performance of PSD Veritas in providing staple line protection for surgical procedures that buttress the stomach and other staple lines during roux-en-Y surgery. The study is designed as two separate patient groups. One will enroll patients into a group where linear staple lines are buttressed at the stomach. The second portion of the trial will enroll patients into a group where the circular staple line at the GJ and linear staple lines at the stomach are buttressed with PSD Veritas.

Eligibility criteria: Inclusion Criteria:

* Patient 18 years or older
* Patient willing to comply with follow-up evaluations
* Patient understands nature of procedure and provides informed consent
* Female patient has stated that she is not pregnant and will not become pregnant during trial.

Exclusion Criteria:

* Patient currently enrolled in another device/drug trial that competes for same patient population
* Patient with short life expectancy (12 months) wherever the cause is not linked to obesity
* BMI is equal or less than 40 and equal to or less than 65
* Patient does not meet National Institute of Health (NIH) criteria for gastric by-pass surgery
* Patient has had previous buttress or other material used in the staple lines that will affect the outcome of this trial.
* Patient has known sensitivity to bovine material

Primary outcomes:
measure: Linear and Circular Arm: Number of Subjects With Major Gastric Related Adverse Events Comparison Between Control and PSD Veritas Groups.
timeFrame: Discharge/ 30 days Linear Discharge/30/90 days Circular
measure: Linear and Circular Arm: Number of Participants With a Leak as Determined by a Comparison of Control Group to PSD Veritas Group.
timeFrame: Discharge/30 Linear Discharge/30/90 days Circular
Secondary outcomes:
measure: Linear Arm: Comparison of Use of Endoclips or Sutures Used for Bleeding in Control Group Versus PSD Veritas Group
timeFrame: Discharge and 30 days
measure: Number of Participants With Stricture Requiring Intervention Between Control Group and PSD Veritas Group. Bleeding Assessment of Control Group to PSD Veritas.
timeFrame: Discharge, 30 and 90 days
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: Division of General Surgery University of Missouri-Columbia
name: Roger De La Torre, MD
role: PRINCIPAL_INVESTIGATOR
References: