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The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty

NCT04112407 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-08-30

No results posted yet for this 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.

Conditions

  • Shoulder Arthroplasty

Interventions

DEVICE

Blue Light Phototherapy

Phototherapy in the blue light spectrum

DRUG

Benzyl Peroxide

Benzyl peroxide wash to be used preoperatively during showering to the operative shoulder site.

OTHER

Control

Standard surgical site preparation with no P. acnes pretreatment

Sponsors & Collaborators

  • Hospital for Special Surgery, New York

    collaborator OTHER

  • Albany Medical College

    lead OTHER

Principal Investigators

  • Ian D Hutchinson, MD · Albany Medical College

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2022-12-01
Completion
2022-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04112407 on ClinicalTrials.gov