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

NCT05392400 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2023-02-13

No results posted yet for this study

Summary

Postpartum infection if a major cause of maternal morbidity and mortality and surgical site infections are some of the common complications following cesarean section. This study aims to determine the effect of Steri3X on the incidence of cesarean section SSI at Regional One Hospital.

Conditions

  • Surgical Site Infection
  • Cesarean Section; Complications, Wound, Infection (Following Delivery)
  • Postpartum Complication

Interventions

DEVICE

Steri3X

This study will initially attempt to recruit pregnant patients at the Regional One Health outpatient obstetrics clinic, at which point they will be randomly assigned to one of two cohorts. Participants who are consented to participate in the study will receive a chart flag in the EMR so that they may receive the proper intraoperative and postoperative treatment(s). Patients randomized to receive the Steri3X wound dressing will have the liquid polymer applied in the operating room after closure of the Cesarean section incision. Participants of both arms will be monitored postoperatively to assess for signs and symptoms of postoperative surgical site infection(s).

OTHER

Control

Device: Steri3X This study will initially attempt to recruit pregnant patients at the Regional One Health outpatient obstetrics clinic, at which point they will be randomly assigned to one of two cohorts. Participants who are consented to participate in the study will receive a chart flag in the EMR so that they may receive the proper intraoperative and postoperative treatment(s). Patients randomized to receive the control wound dressing will have the current standard of care dressing applied in the operating room after closure of the Cesarean section incision. Participants of both arms will be monitored postoperatively to assess for signs and symptoms of postoperative surgical site infection(s).

Sponsors & Collaborators

  • University of Tennessee

    lead OTHER

Principal Investigators

  • Ramona Phinehas, MD · University of Tennessee

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-07
Primary Completion
2024-02-07
Completion
2024-02-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05392400 on ClinicalTrials.gov