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NCT03854370 · ClinicalTrials.gov registry record · NA
Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery
A NA study, sponsored by Wright State University.
- Terminated
- Registry status
- NA
- Development phase
- 35
- Enrollment target
NCT03854370 is a NA study that was terminated before completion, run by Wright State University. The registered enrollment target is 35 participants.
The verdict
NCT03854370, a NA study, was terminated before completion, sponsored by Wright State University.
- TERMINATED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a randomized trial comparing the effectiveness of 4 vaginal prep solutions (betadine, baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during surgery preparation. Women undergoing a vaginal surgery will be enrolled into the trial prior to surgery. Target sample size per group is 15 patients. During standard surgical prep, a vaginal swab will be taken to assess the initial colony counts for aerobic and anaerobic bacteria. After the initial swab, the incision point will be prepared using one of the prep 4 solutions (betadine, baby shampoo, TechniCare or Peridex). After a predefined 10 minutes, the area will be re-swabbed to determine pre-incision colony counts. A third swab will be collected after incision closure. Laboratory analyses for raw colony counts, sensitivities, identification (using MALDI-TOF) will be performed. The results are expected to show that there will be reduced colony counts at the pre-incision point with baby shampoo having the least reduction, followed by betadine and TechniCare, then Peridex. Patient reported outcomes for vaginal itching and burning as well as patient report of any treatment for vaginal infection will be collected by telephone at 2 days, 2 weeks and 1 month post-surgery.
Interventions
- OTHER Baby shampoo
- OTHER Betadine
- OTHER Peridex
- OTHER TechniCare
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2019-06-21 |
| Est. Completion | 2024-01-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03854370
The ClinicalTrials.gov registry entry for NCT03854370 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wright State University, which has 32 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Baby shampoo is the first listed.
NCT03854370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03854370 about?
NCT03854370 is a clinical study titled "Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery". This is a randomized trial comparing the effectiveness of 4 vaginal prep solutions (betadine, baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during surgery preparation. Women undergoing a vaginal surgery will be enrolled into the trial prior to surgery. Target sample size ...
What is the current status of trial NCT03854370?
This trial is currently terminated. It is a NA study. The enrollment target is 35 participants. The study started on 2019-06-21. Estimated completion is 2024-01-01.
What interventions are being tested in trial NCT03854370?
The interventions under investigation include: Baby shampoo (OTHER), Betadine (OTHER), Peridex (OTHER), TechniCare (OTHER).
Who is sponsoring clinical trial NCT03854370?
This trial is sponsored by Wright State University, which has 32 total clinical trials registered on ClinicalTrials.gov.
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