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Antibacterial Suture

Antibacterial-Coated Sutures for Cesarean Section Infection (ASTC Trial)

Phase 4
Recruiting
Research Sponsored by The University of Texas Medical Branch, Galveston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up occurring within 30 days of delivery
Awards & highlights

ASTC Trial Summary

This trial will test whether using antibacterial-coated sutures reduces surgical site infections after cesarean delivery.

Who is the study for?
This trial is for women aged 18-50 who are at least 24 weeks into a viable pregnancy and scheduled for a cesarean delivery. It's not specified who can't join, but typically those with allergies to the materials or other health issues might be excluded.Check my eligibility
What is being tested?
The study is testing if antibacterial-coated sutures (Vicryl-plus, monocryl-plus, PDS-plus) reduce infections after cesarean sections compared to standard sutures (Vicryl, monocryl, PDS).See study design
What are the potential side effects?
Potential side effects may include allergic reactions to suture materials or triclosan coating and complications related to wound healing.

ASTC Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~occurring within 30 days of delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and occurring within 30 days of delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of endometritis and/or wound infection and/or other post-cesarean infections

ASTC Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated SuturesExperimental Treatment1 Intervention
Use of Monocryl Plus, Vicryl Plus and PDS Plus Suture (Triclosan-coated sutures) will be used exclusively throughout the entire procedure.
Group II: Vicryl, monocryl, PDS (not coated with triclosan)Placebo Group1 Intervention
Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.

Find a Location

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
241 Previous Clinical Trials
53,224 Total Patients Enrolled
Benjamin Bush, M.D.Study DirectorUniversity of Texas Medical Branch in Galveston
1 Previous Clinical Trials
612 Total Patients Enrolled
Antonio Saad, M.D.Study DirectorUniversity of Texas Medical Branch in Galveston
1 Previous Clinical Trials
612 Total Patients Enrolled

Media Library

Vicryl-plus, monocryl-plus, PDS-plus (Antibacterial Suture) Clinical Trial Eligibility Overview. Trial Name: NCT03386240 — Phase 4
Surgical Site Infection Research Study Groups: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures, Vicryl, monocryl, PDS (not coated with triclosan)
Surgical Site Infection Clinical Trial 2023: Vicryl-plus, monocryl-plus, PDS-plus Highlights & Side Effects. Trial Name: NCT03386240 — Phase 4
Vicryl-plus, monocryl-plus, PDS-plus (Antibacterial Suture) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03386240 — Phase 4

Frequently Asked Questions

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

What medical procedures are Vicryl-plus, Monocryl-plus and PDS-Plus (Triclosan-coated Sutures) commonly employed for?

"Vicryl-plus, monocryl-plus and PDS-Plus (Triclosan coated Sutures) are proven to be effective at treating a multitude of bacterial infections. Additionally, these sutures have also been successful in healing dermabrasion, gingivitis and abrasions."

Answered by AI

To what degree can individuals rely on the safety of Vicryl-plus, monocryl-plus, and PDS-plus (Triclosan-coated Sutures)?

"All three sutures (Vicryl-plus, monocryl-plus, PDS-plus) have been deemed safe through testing and hence rated 3 on a scale of 1 to 3. This rating indicates that these treatments are approved in the fourth phase of clinical trials."

Answered by AI

Might I qualify for inclusion in this medical experiment?

"This medical trial necessitates that potential candidates suffer from surgical wound infection and are between 18 to 50 years old. Currently, 3374 participants must be enrolled in the study."

Answered by AI

Is this research endeavor currently open to new participants?

"According to clinicaltrials.gov, this study is in its recruitment phase. It was posted on the 9th of January 2018 and has been kept up-to-date as recently as February 10th 2022."

Answered by AI

Has research been conducted on the efficacy of Vicryl-plus, monocryl-plus and PDS-plus (Triclosan-coated Sutures) in comparison to other suture types?

"Presently, there are three studies that probe the efficacy of Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures). However, none have reached Phase 3 yet. Across 21 different medical centres in Galveston and further afield, researchers are analysing this potential treatment."

Answered by AI

Does this medical trial include individuals under the age of 75?

"The terms of enrollment for this medical trial specify that the minimum age is 18 and the maximum age is 50."

Answered by AI

What is the total enrollment capacity for this research endeavor?

"Affirmative. Clinicaltrials.gov has the trial listed as currently open, with a start date of January 9th 2018 and an update on February 10th 2022. This investigation is accepting 3374 patients from one medical centre for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Antibacterial-coated Sutures at Time of Cesarean
2018. "Antibacterial-coated Sutures at Time of Cesarean". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03386240.
~465 spots leftby Apr 2025
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