A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
West Michigan Cancer Center
Summary
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- 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 me…
Interventions
- DeviceStratafix suture
Stratafix symmetric suture
- DeviceStandard of care suture
Standard of care suture
Location
- West Michigan Cancer CenterKalamazoo, Michigan