C.Surgical Procedure; Disruption of Wound, Suture
Conditions
Brief summary
Comparing the use of Stratafix Symmetric™ sutures to standard laparotomy closure sutures.
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.
Interventions
DEVICEStratafix suture
Stratafix symmetric suture
DEVICEStandard of care suture
Standard of care suture
Sponsors
Ethicon, Inc.
West Michigan Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded after the assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who develop ventral incisional hernia | From enrollment to end of study participation at 12 months | Infection, seroma, surgical site infection, evisceration, mesh rejection, systemic complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of stratafix sutures compared to standard of care wound closure | From enrollment to end of study participation at 12 months | Assessing adverse events related to the suture |
| Change in quality of life | Month 1, Month 3, Month 6, Month 12 | Carolinas Comfort Scale (CCS) questionnaire (a validated, disease-specific, quality of life (QOL) questionnaire developed for patients undergoing hernia repair) |
| Post operative pain | From enrollment to end of study participation at 12 months | Visual analog score |
Countries
United States
Contacts
Primary ContactWendi Mitchell
Outcome results
None listed