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

Study Overview
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Brief Summary
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Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial Evaluating the Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery

Conditions
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C.Surgical Procedure; Disruption of Wound, Suture

Intervention / Treatment
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* Device: Stratafix suture
* Device: Standard of care suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is a male or female 18 years of age or older. Participant is a current patient at West Michigan Cancer Center. Participant is undergoing liver, pancreas or biliary or gastrointestinal surgery of a combination of the above, or other major oncological surgery. Participant is willing and able to provide written informed consent before surgery. Exclusion Criteria: Participant has hemodynamic instability at the conclusion of the surgery. (These subjects will be deemed disqualified). Participant has history of previous VIH. Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stratafix Group<br>Stratafix | Device: Stratafix suture<br>* Stratafix symmetric suture<br>|
| Placebo Comparator: Control Group<br>Standard of care | Device: Standard of care suture<br>* Standard of care suture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who develop ventral incisional hernia | Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications | From enrollment to end of study participation at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of stratafix sutures compared to standard of care wound closure | Assessing adverse events related to the suture | From enrollment to end of study participation at 12 months | 
| Change in quality of life | Carolinas Comfort Scale (CCS) questionnaire (a validated, disease-specific, quality of life (QOL) questionnaire developed for patients undergoing hernia repair) | Month 1, Month 3, Month 6, Month 12 | 
| Change in quality of life | Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire (a 45-item questionnaire assesses health-related quality of life in patients with liver, bile duct and pancreatic cancers | Day 1, Month 1, Month 3, Month 6, Month 12 | 
| Post operative pain | Visual analog score | From enrollment to end of study participation at 12 months |