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NCT04609306 · ClinicalTrials.gov registry record · NA
Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast
A NA study of Primary Anatomic or Reverse Total Shoulder Arthroplasty, sponsored by University of Florida.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04609306 is a NA study of Primary Anatomic or Reverse Total Shoulder Arthroplasty that has completed, run by University of Florida. The registered enrollment target is 36 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04609306, a NA study of Primary Anatomic or Reverse Total Shoulder Arthroplasty, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery. Standard skin preparations have been found to be ineffective at eradicating C. acnes colonization on the skin and deep dermis of patients undergoing surgery. Recent literature has shown that skin preparation with 3% hydrogen peroxide solution is effective for decreasing the rate of cultures positive for C. acnes in both dermal and deep cultures; however, a positive rate of 10%-17% has still been reported despite this skin preparations. The current theory is that standard skin preparation does not remove C. acnes from the deep dermis which subsequently contaminates the deep tissue. We hypothesize that application of 3% hydrogen peroxide to the deep dermal layer immediately following the skin incision will even further decrease the rate of C. acnes contamination during surgery.
Conditions Studied
Interventions
- OTHER H2O2 application to incision
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2021-01-26 |
| Est. Completion | 2022-07-07 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04609306
The ClinicalTrials.gov registry entry for NCT04609306 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Primary Anatomic or Reverse Total Shoulder Arthroplasty appearing as the primary indexed condition, and to 1 intervention - of which H2O2 application to incision is the first listed.
NCT04609306 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04609306 about?
NCT04609306 is a clinical study titled "Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast". Cutibacterium acnes has been the focus of much recent shoulder literature, as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery. Standard skin preparations have been found to be ineffective at eradicating C. acnes coloni...
What is the current status of trial NCT04609306?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2021-01-26. Estimated completion is 2022-07-07.
What conditions does trial NCT04609306 study?
This clinical trial studies the following conditions: Primary Anatomic or Reverse Total Shoulder Arthroplasty.
What interventions are being tested in trial NCT04609306?
The interventions under investigation include: H2O2 application to incision (OTHER).
Who is sponsoring clinical trial NCT04609306?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04609306 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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