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Infection-Fighting stitches tested for C-Sections, but trial stopped early

NCT ID NCT03386240

Prevention Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether using stitches coated with an antibacterial agent (triclosan) could reduce infections after cesarean delivery. Over 1,100 women were planned to take part, but the trial was stopped early. Because it was terminated, we cannot draw firm conclusions about whether these special stitches help prevent infections after C-sections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Triclosan-coated sutures (Vicryl-plus, Monocryl-plus, PDS-plus)
What this could lead to
If it had worked, this could have pointed toward a simple way to prevent wound infections after cesarean delivery.
What could go wrong
The trial was terminated early, so we don't have clear evidence that these sutures work for cesarean infections. The results are inconclusive.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

1,169 people

The number who actually took part.

Started

Jan 2018

Finished

Nov 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18-50 years of age. * Women ≥ 24 weeks' viable gestation. * To undergo cesarean delivery. Exclusion Criteria: * Patient unwilling or unable to provide consent. * No prenatal care or a non-resident patient who is unlikely to be followed-up after delivery. * Immunosuppressed patients: i.e., taking systemic immunosuppressant or steroids (e.g. transplant patients; not including steroids for lung maturity), HIV with CD4\<200, or other. * Decision to use other than suture closure (e.g. secondary wound closure, mesh closure). * Skin infection. * Coagulopathy. * High likelihood of additional surgical procedure beyond cesarean (e.g. scheduled hysterectomy, bowel or adnexal surgery). * Allergy to Triclosan. * Incarcerated individuals.

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Conditions

The condition(s) this trial relates to.

Infections puerperal infection Surgical Wound Infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cesarean section complications Cesarean section; infection Surgical site infection Surgical wound infection

Contacts and locations

Locations

  • University of Texas Medical Branch in Galveston

    Galveston, Texas, 77550, United States

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