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

West Michigan Cancer Center100 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

C.Surgical Procedure; Disruption of Wound, Suture

Interventions

Stratafix sutureDEVICE

Stratafix symmetric suture

Standard of care sutureDEVICE

Standard of care suture

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

West Michigan Cancer Center

Kalamazoo, Michigan, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants who develop ventral incisional hernia

Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications

Time frame: From enrollment to end of study participation at 12 months

Secondary Outcomes

Safety of stratafix sutures compared to standard of care wound closure

Assessing adverse events related to the suture

Time frame: 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)

Time frame: "Month 1," "Month 3," "Month 6," "Month 12"

Change in quality of life

Functional Assessment of Cancer Therapy-G (FACT-G) questionnaire (a 27-item questionnaire designed to measure four domains of HRQOL in cancer patients: Physical, social, emotional, and functional well-being.)

Time frame: "Day 1," "Month 1," "Month 3," "Month 6," "Month 12"

Post operative pain

Visual analog score

Time frame: From enrollment to end of study participation at 12 months

Central Contacts

Wendi Mitchell

CONTACT

269-373-7443 research@wmcc.org

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.