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NCT06831422 · ClinicalTrials.gov registry record · NA
Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty
A NA study of Shoulder Arthroplasty and Positive C. Acnes Culture, sponsored by Henry Ford Health System.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06831422: Recruiting NA study of Shoulder Arthroplasty and Positive C. Acnes Culture, sponsored by Henry Ford Health System.
NCT06831422 is a NA study of Shoulder Arthroplasty and Positive C. Acnes Culture that is actively recruiting participants, run by Henry Ford Health System. The registered enrollment target is 150 participants, below the 1,076-participant average among 5 other Shoulder Arthroplasty trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06831422, a NA study of Shoulder Arthroplasty and Positive C. Acnes Culture, is actively recruiting participants, sponsored by Henry Ford Health System.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:1 fashion to groups that will receive one of the following treatments: * Post-incision application of Xperience Antimicrobial wash (NextScience, Jacksonville, FL) * Post-incision application of 3% hydrogen peroxide * Post-incision application of 10% povidone-iodine (betadine) * No post-incision treatment (control) The investigators hypothesize that the subjects treated with the antimicrobial solutions after initial incision will have lower rates of positive C. Acnes cultures. The investigators also hypothesize that post-incision application of Xperience Antimicrobial wash and Betadine will have an equal reduction in the incidence of C. acnes as Hydrogen Peroxide.
Primary Outcome
C. Acnes cultures will be sampled from surgical site prior to the initial incision (skin culture), from the incision site after the initial incision (dermal culture), from the glenohumeral joint (glenohumeral joint culture), and from the room air (air culture). Each culture will be monitored for up to 18 days for growth of C. Acnes.
Conditions Studied
Interventions
- DEVICE Povidone-Iodine
- DEVICE Hydrogen Peroxide
- DEVICE Xperience Antimicrobial Wash
- DIAGNOSTIC_TEST Bacterial Cultures
- PROCEDURE Shoulder Arthroplasty
Study Locations (1)
Michigan
- Henry Ford Health - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-05-05 |
| Est. Completion | 2027-09 |
| Phase | NA |
What NCT06831422 shows while recruiting
NCT06831422 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 1,076-participant average among 5 other Shoulder Arthroplasty trials with a reported enrollment target (86% lower).
The record links to 2 conditions, with Shoulder Arthroplasty appearing as the primary indexed condition, and to 5 interventions - of which Povidone-Iodine is the first listed.
NCT06831422 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT06831422 about?
NCT06831422 is a clinical study titled "Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty". The purpose of this randomized controlled trial is to determine the effect of post-incision wash using various novel antimicrobial solutions on the rate of positive C. Acnes cultures collected from adults undergoing primary shoulder replacement surgery. Subjects will be randomly assigned in a 1:1:1:...
What is the current status of trial NCT06831422?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2025-05-05. Estimated completion is 2027-09.
What conditions does trial NCT06831422 study?
This clinical trial studies the following conditions: Shoulder Arthroplasty, Positive C. Acnes Culture.
What interventions are being tested in trial NCT06831422?
The interventions under investigation include: Povidone-Iodine (DEVICE), Hydrogen Peroxide (DEVICE), Xperience Antimicrobial Wash (DEVICE), Bacterial Cultures (DIAGNOSTIC_TEST), Shoulder Arthroplasty (PROCEDURE).
Who is sponsoring clinical trial NCT06831422?
This trial is sponsored by Henry Ford Health System, which has 234 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06831422 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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