What side effects are associated with this type of intervention?

Common treatments for Surgical Site Infections (SSIs) include the use of antibiotics and antimicrobial agents, such as those released by antibacterial-coated sutures. The known side effects of these treatments can include allergic reactions, gastrointestinal disturbances (such as nausea, vomiting, and diarrhea), and the development of antibiotic-resistant bacteria. Additionally, prolonged use of antibiotics can lead to secondary infections like Clostridioides difficile colitis. It is important to discuss these potential side effects with a healthcare provider to ensure appropriate management and monitoring.

What prior FDA approvals exist?

The FDA has approved various treatments aimed at reducing Surgical Site Infections (SSIs) by releasing antimicrobial agents. One notable example is the use of antibacterial-coated sutures, which are designed to inhibit bacterial growth at the surgical site. These sutures are coated with antimicrobial agents such as triclosan, which has been shown to reduce the incidence of SSIs in various surgical procedures. While specific FDA approvals for antibacterial-coated sutures in cesarean deliveries are not detailed, the general approach of using antimicrobial-coated materials to prevent infections is well-supported by clinical evidence.

What other types of research exist?

Promising novel alternatives to antibacterial-coated sutures for preventing surgical site infections in 2024 include: 1) Antibacterial peptide Cec4, which has shown superior efficacy in reducing biofilms and no cytotoxicity. 2) ZIF nano-dagger coated gauze, which is effective against both Gram-positive and Gram-negative bacteria, has lower cytotoxicity, and improves wound healing. These alternatives offer multi-target interactions and enhanced biocompatibility, making them attractive options for SSI prevention.

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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

Pivotal Trial

Drug Has Already Been Approved

Summary

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

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.

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).

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ occurring within 30 days of delivery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antibacterial-coated sutures release antimicrobial agents that inhibit bacterial growth, thereby reducing the risk of surgical site infections (SSI). This is crucial for SSI patients as it directly targets bacteria at the wound site, minimizing infection risk and promoting faster healing. Other common treatments include prophylactic antibiotics, which prevent bacterial colonization and infection by targeting potential pathogens before they can establish an infection.

Liberal or restrictive antimicrobial prophylaxis for surgical site infection: systematic review and meta-analysis of randomised trials.Long-term antibiotic prophylaxis regimen compared to short-term antibiotic prophylaxis regimen in patients undergoing orthognathic surgery.Clinical Adverse Events after Endoscopic Resection for Colorectal Lesions: A Meta-Analysis on the Antibiotic Prophylaxis.