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Sutures for Stoma Complications

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Southern California
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn whether chromic gut or polyglactin 910 suture results in fewer stoma complications when used to mature an enterostomy in patients undergoing planned ostomy creation. The main questions it aims to answer are:

* Does the choice of suture material affect the rate of early local stoma complications?

* Does the choice of suture material affect post operative pain at the stoma site?

Researchers will compare the half of the stoma matured with chromic gut to the half matured with polyglactin 910, within the same participant, to see if one suture leads to fewer complications.

Participants will:

* Undergo creation of an ostomy as part of their planned operation, with one half of the stoma matured using chromic gut suture and the other half using polyglactin 910 suture, with the side assigned at random

* Attend two follow up visits after discharge from the hospital for their index operation

Are You a Good Fit for This Trial?

This trial is for people who are scheduled to have an ostomy (a surgical opening in the abdomen) created as part of their planned surgery. There are no detailed inclusion or exclusion criteria listed.

Inclusion Criteria

Patients able and willing to provide informed consent
I am 18 years old or older.
I am having surgery to create an opening in my abdomen for waste removal.

Exclusion Criteria

Patients with known suture material allergy
I have an active infection where my surgery will be performed.
I have a known blood clotting disorder.

What Are the Treatments Tested in This Trial?

Interventions

  • Chromic Gut Suture
  • Polyglactin 910 Suture

Trial Overview

The study compares two types of stitches—chromic gut and polyglactin 910—for closing the stoma during ostomy creation. Each participant will receive both types, one on each half of their stoma, assigned randomly. Researchers want to see which suture leads to fewer complications and less pain.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Chromic gut right, polyglactin 910 leftExperimental Treatment2 Interventions
Group II: Chromic gut left, polyglactin 910 rightExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

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