Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) for Cesarean Section Infection

University of Texas Medical Branch in Galveston, Galveston, TX
Cesarean Section Infection+3 More ConditionsVicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) - Drug
18 - 50
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Cesarean Section Infection
  • Surgical Site Infection
  • Cesarean Section Complications
  • Surgical Site Infections

Treatment Effectiveness

Phase-Based Effectiveness

3 of 3
Phase 4
This is further along than 93% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: occurring within 30 days of delivery

Day 30
Composite of endometritis and/or wound infection and/or other post-cesarean infections

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures
1 of 2
Vicryl, monocryl, PDS (not coated with triclosan)
1 of 2

Experimental Treatment

Non-Treatment Group

3374 Total Participants · 2 Treatment Groups

Primary Treatment: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) · Has Placebo Group · Phase 4

Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures
Experimental Group · 1 Intervention: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures) · Intervention Types: Drug
Vicryl, monocryl, PDS (not coated with triclosan)
PlaceboComparator Group · 1 Intervention: Vicryl, monocryl, PDS (not coated with triclosan) · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: occurring within 30 days of delivery

Who is running the clinical trial?

The University of Texas Medical Branch, GalvestonLead Sponsor
227 Previous Clinical Trials
51,584 Total Patients Enrolled
Antonio Saad, M.D.Study DirectorUniversity of Texas Medical Branch in Galveston
1 Previous Clinical Trials
612 Total Patients Enrolled

Eligibility Criteria

Age 18 - 50 · Female Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Is this research endeavor currently open to new participants?

"According to, 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

What is the total enrollment capacity for this research endeavor?

"Affirmative. 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.