Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Purpose

Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Condition

  • C.Surgical Procedure; Disruption of Wound, Suture

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Participant is a male or female 18 years of age or older. 2. Participant is a current patient at West Michigan Cancer Center. 3. Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery. 4. Participant is willing and able to provide written informed consent before surgery.

Exclusion Criteria

  1. Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified). 2. Participant has history of previous VIH. 3. Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)
Masking Description
Patients will be blinded after the assignment.

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Stratafix Group 		Stratafix
  • Device: Stratafix suture
    Stratafix symmetric suture
Placebo Comparator
Control Group 		Standard of care
  • Device: Standard of care suture
    Standard of care suture

Recruiting Locations

West Michigan Cancer Center
Kalamazoo, Michigan 49007
Contact:
Wendi Mitchell
269-373-7443
wmitchell@wmcc.org

More Details

Status
Recruiting
Sponsor
West Michigan Cancer Center

Study Contact

Wendi Mitchell
269-373-7443
research@wmcc.org

Detailed Description

Determine whether the use of Stratafix Symmetric™ sutures reduces the development of Ventral Incisional Hernia (VIH) in patients undergoing complex GI surgery compared to standard laparotomy closure. Determine the safety of Stratafix Symmetric™ sutures compared to standard laparotomy closure sutures and the impact on quality of life and level of pain.