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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether antibacterial-coated sutures (such as Vicryl-plus, Monocryl-plus, PDS-plus) can reduce infections after cesarean delivery. Previous studies showed these sutures help in other surgeries, but they have not been tested in c-sections yet. The trial includes two groups: one using sutures with an antibacterial coating and the other using regular sutures. Women who are at least 24 weeks pregnant and planning a cesarean delivery might be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it can benefit more patients.

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.

What is the safety track record for these treatments?

Research has shown that triclosan-coated stitches, such as Vicryl Plus, are generally safe for people. Studies have found that these stitches can significantly lower the risk of infections at surgery sites compared to those without the antibacterial coating. For instance, one study found that these stitches reduced the risk of infection by 43% in childbirth-related surgeries.

Most people tolerate these stitches well, and studies have reported no major safety issues. Triclosan, the antibacterial ingredient in the coating, is also used in everyday products like toothpaste and is known to be safe. Since this trial is in a later phase, the stitches have already undergone safety testing in earlier research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about triclosan-coated sutures like Vicryl-plus, Monocryl-plus, and PDS-plus because they offer a unique approach to preventing infections after a cesarean section. Unlike standard sutures, these are coated with triclosan, an antibacterial agent that helps reduce the risk of surgical site infections by preventing bacterial growth directly at the incision site. This added antibacterial protection is what sets them apart from the usual uncoated sutures, potentially leading to quicker recovery times and fewer complications for new mothers.

What evidence suggests that antibacterial-coated sutures are effective for reducing surgical site infections after cesarean delivery?

This trial will compare triclosan-coated sutures with uncoated sutures in cesarean sections. Research has shown that triclosan-coated stitches can significantly reduce infections at surgical sites. Studies have found that these stitches can lower infection rates by almost 50% in various surgeries. Triclosan, an antibacterial substance, prevents bacteria from growing on the stitches, helping to prevent infections. Overall, these stitches have been linked to a significant reduction in surgical site infections compared to regular stitches. Although specific data for cesarean sections is not available, success in other surgeries suggests they might be effective for this procedure as well. ^{1 3 6 7 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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12051262/

efficacy of triclosan coated suture (VicrylPlus®) to reduce ... The PLUS study demonstrated that TCS effectively reduces infection rates by nearly 50% in primary sutured CRPTs, excluding first-degree tears.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6731927/

The use of triclosan-coated sutures to prevent surgical site ... Triclosan-coated sutures have been shown to significantly reduced the risk of SSIs when compared with standard sutures.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2831130

Triclosan-Containing Sutures for the Prevention of Surgical ... These findings support wound closure with triclosan-containing sutures to reduce the risk of surgical site infections across all types of surgery.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673614602385

Articles Effectiveness of triclosan-coated PDS Plus versus ... Triclosan-coated PDS Plus sutures and uncoated PDS II sutures were associated with equal rates of surgical site infection after continuous closure of the ...

5. withpower.com withpower.com/trial/phase-4-wound-infection-2018-99945

Antibacterial-Coated Sutures for Cesarean Section Infection Research shows that antibacterial-coated sutures, like Vicryl Plus, can significantly reduce the risk of surgical site infections compared to non-coated ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9754295/

Evaluation of Triclosan coated suture in obstetrical surgery To assess the effectiveness of Triclosan coated suture in reducing surgical site infections (SSIs) rate after caesarian delivery (CD).

7. jnjmedtech.com jnjmedtech.com/sites/default/files/user_uploaded_assets/pdf_assets/2020-11/Plus-Sutures-Evidence-Summary-103240-181127.pdf

Plus Antibacterial Sutures Evidence Summary This Evidence Summary is a compilation of technical information, clinical and economic data, and research published over the last decade that demonstrates the ...

8. researchgate.net researchgate.net/publication/391454462_The_PLUS_study_efficacy_of_triclosan_coated_suture_VicrylPlus_to_reduce_infection_in_primary_suture_of_childbirth_related_perineal_tears_-_a_randomized_controlled_trial

efficacy of triclosan coated suture (VicrylPlus) to reduce ... Conclusion The use of triclosan coated sutures significantly reduces the risk of infection in primary sutured childbirth-related perineal tears ...