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NCT05919888 · ClinicalTrials.gov registry record · Phase 4
SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty
A Phase 4 study of Surgery and Surgical Site Infection, sponsored by St. Louis University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05919888: Completed Phase 4 study of Surgery and Surgical Site Infection, sponsored by St. Louis University.
NCT05919888 is a Phase 4 study of Surgery and Surgical Site Infection that has completed, run by St. Louis University. The registered enrollment target is 60 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05919888, a Phase 4 study of Surgery and Surgical Site Infection, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.
Primary Outcome
Each participant had culture swabs at end of surgical case from deep, superficial, and implant locations. Cultures were held in the lab for 2 weeks to evaluate for the presence of bacteria. The number of patients with at least one positive culture were compared among the three study arms.
Conditions Studied
Interventions
- DRUG Povidone-Iodine
- DEVICE SURGX Wound Gel
Study Locations (1)
Missouri
- Saint Louis University - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 4 |
What the finished NCT05919888 record still lists
NCT05919888 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Surgery appearing as the primary indexed condition, and to 2 interventions - of which Povidone-Iodine is the first listed.
NCT05919888 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05919888 about?
NCT05919888 is a clinical study titled "SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep in Total Shoulder Arthroplasty". Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the de...
What is the current status of trial NCT05919888?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2023-06-26. Estimated completion is 2023-11-14.
What conditions does trial NCT05919888 study?
This clinical trial studies the following conditions: Surgery, Surgical Site Infection, Prosthetic-joint Infection, Cutibacterium Acnes.
What interventions are being tested in trial NCT05919888?
The interventions under investigation include: Povidone-Iodine (DRUG), SURGX Wound Gel (DEVICE).
Who is sponsoring clinical trial NCT05919888?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05919888 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Surgery
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05919888's enrollment target sits among peer trials
60 81st of 120 higher than 36 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery 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.
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