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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

Must not have

Chorioamnionitis or other existing infection excluded (Single maternal fever >39 C, 2 maternal fevers > 38, or clinical risk factors for chorioamnionitis)

Patients receiving Prevena or other wound vac

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 8 weeks

Awards & highlights

No Placebo-Only Group

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).

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.

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

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You will not receive Steri3X immediately after your surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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You are currently using a device called Prevena or any other wound vac.

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

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

Primary study objectives

Surgical Site Infection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 3Eligibility criteria met