Antibacterial-Coated Sutures for Cesarean Section Infection

(ASTC Trial)

Overseen By Benjamin Bush, M.D.

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Immunosuppression, Skin infection, Coagulopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

1122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing whether special stitches with a germ-killing coating can reduce infections in women after cesarean deliveries.

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking systemic immunosuppressants or steroids, you may not be eligible to participate.

Is it safe to use antibacterial-coated sutures in humans?

Research shows that antibacterial-coated sutures, like Vicryl Plus, have been studied for safety and are generally considered safe for use in humans. They have been used in various surgeries, including appendectomies and craniotomies, with no significant safety concerns reported. ^{1 2 3 4 5}

How is the antibacterial-coated suture treatment for cesarean section infection different from other treatments?

This treatment uses sutures coated with triclosan, an antibacterial agent, which helps prevent infections by stopping bacteria from growing on the suture material itself, making it unique compared to traditional sutures that do not have this protective coating. ^{1 3 4 6 7}

What data supports the effectiveness of antibacterial-coated sutures for reducing infections after a cesarean section?

Research shows that antibacterial-coated sutures, like Vicryl Plus, can significantly reduce the risk of surgical site infections compared to non-coated sutures. This has been observed in various surgeries, including appendectomies, suggesting they may also be effective for cesarean sections. ^{1 2 3 4 8}

Who Is on the Research Team?

Benjamin Bush, M.D.

Principal Investigator

University of Texas Medical Branch in Galveston

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Women ≥ 24 weeks' viable gestation.

To undergo cesarean delivery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cesarean delivery using either antibacterial-coated or uncoated sutures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infections and other post-cesarean infections

4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Vicryl, monocryl, PDS (not coated with triclosan)
• Vicryl-plus, monocryl-plus, PDS-plus

Trial Overview 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).

How Is the Trial Designed?

Group I: Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures Experimental Treatment 1 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 Group 1 Intervention

Use of Monocryl, Vicryl and PDS Suture (equivalent uncoated sutures) will be used exclusively throughout the whole procedure.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Triclosan coated suture in obstetrical surgery: A prospective randomized controlled study (NCT05330650). [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Biomaterial suture Vicryl Plus reduces wound-related complications. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Antimicrobial-coated sutures to decrease surgical site infections: a systematic review and meta-analysis. [2022]

4. Thailand pubmed.ncbi.nlm.nih.gov

Efficacy of antimicrobial coating suture coated polyglactin 910 with tricosan (Vicryl plus) compared with polyglactin 910 (Vicryl) in reduced surgical site infection of appendicitis, double blind randomized control trial, preliminary safety report. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The Spiral Trial: A multicenter, randomized, controlled trial of Spiral thread sutures versus conventional thread sutures to prevent thinning of uterine scars following elective cesarean section. [2021]

6. Spain pubmed.ncbi.nlm.nih.gov

[Prevention of surgical infection using reabsorbable antibacterial suture (Vicryl Plus) versus reabsorbable conventional suture in hernioplasty. An experimental study in animals]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Antibacterial [corrected] coating of abdominal closure sutures and wound infection. [2022]

8. Spain pubmed.ncbi.nlm.nih.gov

Predictors of wound infection in elective colorectal surgery. Multicenter observational case-control study. [2014]