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NCT04112407 · ClinicalTrials.gov registry record · NA
The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty
A NA study of Shoulder Arthroplasty, sponsored by Albany Medical College.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 2
- Study locations
NCT04112407: Completed NA study of Shoulder Arthroplasty, sponsored by Albany Medical College.
NCT04112407 is a NA study of Shoulder Arthroplasty that has completed, run by Albany Medical College. The registered enrollment target is 120 participants, below the 1,082-participant average among 5 other Shoulder Arthroplasty trials with a reported enrollment target (89% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04112407, a NA study of Shoulder Arthroplasty, has completed, sponsored by Albany Medical College.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 2
- Study locations
Study Summary
Cutibacterium acnes - formally known as Propionibacter acnes (P. acnes) is the most common pathogen associated with prosthetic joint infection of the shoulder. Despite current skin preparation techniques, P. acnes is encountered at the skin surface and at the natural reservoir in the sebaceous glands during the surgical exposure; current levels of exposure are implicated in overall prosthetic infection risk. Therefore, this study endeavors to decrease P. acnes burden at the surgical incision using preoperative blue light phototherapy and benzyl peroxide washes targeting both the skin surface and sebaceous glands.
Primary Outcome
To compare the rates of P. Acnes culture positivity (including all samples) between groups. Therein, assessing the efficacy of the interventions to decrease P. Acnes burden (measured by the rate of culture positivity) in surgical field.
Conditions Studied
Interventions
- OTHER Control
- DEVICE Blue Light Phototherapy
- DRUG Benzyl Peroxide
Study Locations (2)
New York
- Albany Medical Center - Albany
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2019-01-10 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
What the finished NCT04112407 record still lists
NCT04112407 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,082-participant average among 5 other Shoulder Arthroplasty trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Shoulder Arthroplasty appearing as the primary indexed condition, and to 3 interventions - of which Control is the first listed.
NCT04112407 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04112407 about?
NCT04112407 is a clinical study titled "The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty". Cutibacterium acnes - formally known as Propionibacter acnes (P. acnes) is the most common pathogen associated with prosthetic joint infection of the shoulder. Despite current skin preparation techniques, P. acnes is encountered at the skin surface and at the natural reservoir in the sebaceous gland...
What is the current status of trial NCT04112407?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2019-01-10. Estimated completion is 2022-12-31.
What conditions does trial NCT04112407 study?
This clinical trial studies the following conditions: Shoulder Arthroplasty.
What interventions are being tested in trial NCT04112407?
The interventions under investigation include: Control (OTHER), Blue Light Phototherapy (DEVICE), Benzyl Peroxide (DRUG).
Who is sponsoring clinical trial NCT04112407?
This trial is sponsored by Albany Medical College, which has 52 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04112407 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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