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Antimicrobial Coating

Steri3X for Cesarean Section Wound Infection Prevention

Phase 2

Waitlist Available

Research Sponsored by University of Tennessee

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Application of Steri3X immediately post-op

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

Study Summary

This triallooks at the effects of Steri3X on reducing the risk of infection after cesarean section births.

Who is the study for?

This trial is for women aged 16 or older undergoing cesarean sections, including first-time and repeat procedures. It's suitable for those with diabetes or obesity. Women must not have current infections like chorioamnionitis, be using other wound treatments like Prevena, have had membranes ruptured over 24 hours, or be on antibiotics (except for GBS prophylaxis).Check my eligibility

What is being tested?

The study tests Steri3X's effectiveness in preventing surgical site infections after cesarean sections compared to a control group without it. Participants will receive the Steri3X treatment immediately after their operation at Regional One Hospital.See study design

What are the potential side effects?

Potential side effects of Steri3X are not specified here but may include skin irritation or allergic reactions at the application site. As this is a preventative measure against infection, risks are likely minimal compared to its potential benefits.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You will not receive Steri3X immediately after your surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical Site Infection

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention

Patients randomized to the Experimental group will receive treatment with Steri3x immediately following closure of the Cesarean section incision. Participants in the experimental group will receive approximately 48 hours of post-op hospitalization and wound surveillance.

Group II: ControlActive Control1 Intervention

Currently, the standard of care for Cesarean section patients includes covering the closed incision with a sterile bandage to reduce the chance of infection, and approximately 48 hours of post-op hospitalization and wound surveillance. The "control" group will receive post-operative wound dressings consistent with the current standard of care.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

University of TennesseeLead Sponsor

188 Previous Clinical Trials

140,641 Total Patients Enrolled

Bethany EricksonLead Sponsor

Ramona Phinehas, MDStudy DirectorUniversity of Tennessee

Media Library

Steri3X (Antimicrobial Coating) Clinical Trial Eligibility Overview. Trial Name: NCT05392400 — Phase 2

Cesarean Wound Infection Research Study Groups: Experimental, Control

Cesarean Wound Infection Clinical Trial 2023: Steri3X Highlights & Side Effects. Trial Name: NCT05392400 — Phase 2

Steri3X (Antimicrobial Coating) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05392400 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Experimental been given clearance by the FDA?

"Our team at Power has assigned a safety rating of 2 to Experimental, given its Phase 2 trial status and the presence of some data indicating safe usage. Nonetheless, no evidence presently exists that would support efficacy."

Answered by AI

Is this experiment still signing up participants?

"Negative. According to clinicaltrials.gov data, this trial is no longer seeking patients; it was initially posted on February 7th 2023 and most recently updated two days later. However, there are 1563 other trials that remain open for recruitment currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections

Bethany Erickson 2023. "The Use of Steri3X for Prevention of Post-operative Wound Infections in Cesarean Sections". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05392400.

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