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Procedure

Barbed vs Non-Barbed Sutures for Emergency Abdominal Surgery

N/A

Waitlist Available

Led By Matthew Martin, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All adult individuals aged 18 years or older who undergo emergent laparotomy via a midline approach for trauma or non-trauma emergency general surgery who undergo complete fascial closure at the time of the index laparotomy operation

Individuals with CDC Class I, II, III and IV type surgical wounds

Must not have

Individuals under 18 years of age

Individuals taking chronic immunosuppressive medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days postoperatively

Summary

This trial compares two types of sutures to reduce rates of surgical site infection and dehiscence after emergency laparotomy. It will be conducted at Los Angeles General Medical Center and outcomes will be compared between study arms.

Who is the study for?

Adults aged 18+ needing emergency exploratory laparotomy for trauma or acute abdominal issues, who can have their abdomen fully closed during surgery. Excludes those with multiple surgeries planned, incarcerated individuals, preexisting connective tissue diseases or hernias, pregnant women, minors, immune deficiencies, chronic immunosuppression medication users, nosocomial infections or pre-existing hernia.

What is being tested?

The trial is testing if triclosan-coated barbed sutures are better than conventional non-barbed sutures at preventing wound separation and infections after emergency abdominal surgery. Participants will be randomly assigned to one of the suture types and monitored for 30 days post-surgery.

What are the potential side effects?

Potential side effects may include surgical site infection and fascial dehiscence (wound reopening) related to the type of suture used. The study aims to determine which suture minimizes these complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult who had emergency surgery through a midline cut and my deep cut was fully closed.

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I have a surgical wound classified by the CDC.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am under 18 years old.

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I am on long-term medication to suppress my immune system.

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I was not lost to follow-up or deceased within 30 days after my surgery.

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I need several surgeries to close my wound.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fascial Dehiscence Incidence

Surgical Site Infection Incidence

Wound Complication events

Secondary study objectives

Hospital Length of Stay

ICU Length of Stay

Incidence of Prolonged Postoperative Antibiotics

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Triclosan-coated barbed suture groupActive Control1 Intervention

The active arm of the study will including patients randomized to abdominal fascial closure with using triclosan-coated barbed (STRATAFIX™ Symmetric PDS™, Johnson \& Johnson) suture after emergency exploratory laparotomy.

Group II: Non-barbed suture groupPlacebo Group2 Interventions

The control arm of the study will including patients randomized to abdominal fascial closure with using non-barbed triclosan-coated suture(PDS™ Plus, Johnson \& Johnson) or non-coated polydioxanone (PDS™ II,Johnson \& Johnson) suture after emergency exploratory laparotomy.

0 / 6Eligibility criteria met