Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery (STRATA-G)

West Michigan Cancer Center

Status: Enrolling

Conditions: C.Surgical Procedure; Disruption of Wound, Suture

Treatments: Device: Standard of care suture; Device: Stratafix suture

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06063577

001-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Stratafix Group

Active Comparator group

Description:

Stratafix

Treatment:

Device: Stratafix suture

Control Group

Placebo Comparator group

Description:

Standard of care

Treatment:

Device: Standard of care suture