Recruiting

Stratafix Symmetric™ vs. Standard Sutures

Sponsor:

West Michigan Cancer Center

Code:

NCT06063577

Conditions

C.Surgical Procedure; Disruption of Wound, Suture

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Stratafix suture

Standard of care suture

Study Details

Brief summary:

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

Conditions

C.Surgical Procedure; Disruption of Wound, Suture

Study ID

NCT06063577

Start date

Dec 1, 2023

Status verified date

Jan, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stratafix Group

Stratafix

placebo comparator: Control Group

Standard of care

Interventions

Stratafix suture

Stratafix symmetric suture

Standard of care suture

Standard of care suture

Primary outcome measure

  • Number of participants who develop ventral incisional hernia [ Time Frame: From enrollment to end of study participation at 12 months ]

Central Contacts and Locations

Central contacts

Wendi Mitchell

269-373-7443research@wmcc.org

Locations

West Michigan Cancer Center

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Wendi Mitchell

269-373-7443wmitchell@wmcc.org

Kathleen Allen

269-373-7452kallen@wmcc.org

Principal Investigator:

Gitonga Munene, MD

More Information

Sponsor

West Michigan Cancer Center

Last update posted

Feb 2, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by West Michigan Cancer Center on 2024-02-02.