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Procedure

Stratafix Suture for Preventing Incisional Hernia (STRATA-G Trial)

N/A
Recruiting
Led By Gitonga Munene
Research Sponsored by West Michigan Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Participant has a mental condition rendering the subject incapable of understanding the nature, scope and consequences of the study.
Participant has hemodynamic instability at the conclusion of the surgery (These subjects will be deemed disqualified)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment to end of study participation at 12 months

Summary

This trial studies how one type of suture compares to another for closing surgical incisions.

Who is the study for?
This trial is for adults over 18 who are undergoing liver, pancreas, biliary or gastrointestinal surgery, or other major oncological surgeries at West Michigan Cancer Center. They must be able to understand the study and agree to participate. People with hemodynamic instability after surgery, a history of VIH (presumably HIV), or mental conditions affecting study comprehension cannot join.
What is being tested?
The trial compares Stratafix Symmetric™ sutures against standard sutures used in closing surgical incisions from abdominal operations. The goal is to see if Stratafix can better prevent complications like incisional hernias and wound dehiscence.
What are the potential side effects?
While specific side effects aren't listed for Stratafix sutures, potential risks may include typical suture-related complications such as infection at the wound site, allergic reactions to suture materials, pain, swelling and delayed healing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery for cancer in my liver, pancreas, bile ducts, or gastrointestinal tract.
Select...
I am willing and able to sign a consent form before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am unable to understand the study due to a mental condition.
Select...
I was stable after my surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment to end of study participation at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment to end of study participation at 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants who develop ventral incisional hernia
Secondary study objectives
Change in quality of life
Post operative pain
Safety of stratafix sutures compared to standard of care wound closure

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Stratafix GroupActive Control1 Intervention
Stratafix
Group II: Control GroupPlacebo Group1 Intervention
Standard of care

Find a Location

Who is running the clinical trial?

West Michigan Cancer CenterLead Sponsor
1 Previous Clinical Trials
72 Total Patients Enrolled
Ethicon, Inc.Industry Sponsor
92 Previous Clinical Trials
62,121 Total Patients Enrolled
Gitonga MunenePrincipal InvestigatorWest Michigan Cancer Center
~67 spots leftby Dec 2026
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