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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days postoperatively
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am an adult who had emergency surgery through a midline cut and my deep cut was fully closed.
Select...
I have a surgical wound classified by the CDC.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fascial Dehiscence Incidence
Surgical Site Infection Incidence
Wound Complication events
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
905 Previous Clinical Trials
1,596,028 Total Patients Enrolled
Matthew Martin, MDPrincipal InvestigatorLos Angeles General Medical Center

Frequently Asked Questions

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

Are there vacancies for this experiment at the moment?

"The information hosted on clinicaltrials.gov discloses that this medical trial is not currently searching for participants. It was originally posted on October 1st 2023 and its most recent update occurred September 12th 2023. Fortunately, there are 993 other trials actively accepting patients to join their study."

Answered by AI

What aims are investigators hoping to achieve through this research endeavor?

"This clinical trial will evaluate Surgical Site Infection Incidence over the course of 30 days following a surgery. Additional metrics observed include ICU Length of Stay, Unplanned Reoperation rate, and Prolonged Postoperative Antibiotics administration frequency."

Answered by AI

Does my profile meet the prerequisites for enrolling in this research endeavor?

"A laparotomy and being aged between 18-100 years of age are the requirements for enrolment into this research project. A total of 250 people will be accepted in this study."

Answered by AI

Does this clinical trial allow geriatric individuals to participate?

"As set out in the terms for enrolling, this medical trial requires that all participants are aged 18 or above and not over 100."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT
Matthew Martin 2024. "Barbed Suture vs Non-Barbed Closure for Emergency Exploratory Laparotomy RCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043414.
~167 spots leftby Sep 2026
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