Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Clinical Trial NA study, sponsored by Wright State University.
NCT03854370 is a NA study that was terminated before completion, run by Wright State University. The registered enrollment target is 35 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
anaerobic culture colony counts - change in anaerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
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 |
Why NCT03854370 stopped before completion
NCT03854370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 4 interventions - of which Baby shampoo is the first listed.
NCT03854370 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03854370's enrollment target sits among peer trials
35 1564th of 2000 higher than 431 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01697371 · 35 participants · NA
Proton Therapy in the Treatment of Liver Metastases
- NCT01940757 · 35 participants · Phase 1
Experimental Infection of Hookworm-naïve Adults With Dermally-applied Infectious Necator Americanus Hookworm Larvae
- NCT02235857 · 35 participants · NA
Post Approval Study of Liposorber LA-15 System for the Treatment of Focal Segmental Glomerulosclerosis in Children
- NCT02637934 · 35 participants · Phase 1
Phase I Pilot Study of Biodistribution, Metabolism and Excretion of Novel Radiotracer [18F]Fluorthanatrace (FTT) by PET/CT
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI