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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from enrollment to end of study participation at 12 months

Awards & highlights

STRATA-G Trial 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.Check my eligibility

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.See study design

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.

STRATA-G Trial 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.

STRATA-G Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from enrollment to end of study participation at 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants who develop ventral incisional hernia

Secondary outcome measures

Change in quality of life

Post operative pain

Safety of stratafix sutures compared to standard of care wound closure

STRATA-G Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Stratafix GroupActive Control1 Intervention

Stratafix

Group II: Control GroupPlacebo Group1 Intervention

Standard of care

0 / 2Eligibility criteria met

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

91 Previous Clinical Trials

60,221 Total Patients Enrolled

Gitonga MunenePrincipal InvestigatorWest Michigan Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this research project?

"Affirmative. Analysis of the clinicaltrials.gov website implies that this examination is actively recruiting participants, with a total quota of 100 people between 1 facility. The trial was initially posted on October 1st 2023 and most recently amended on October 6th 2023."

Answered by AI

Are there any vacancies for the trial that are available to those interested in participating?

"The clinical trial in question is currently seeking participants. This experiment, initially posted on October 1st 2023 and subsequently revised on the 6th of October 20203, has been officially launched."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Gitonga Munene 2023. "Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06063577.

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