RECRUITING

Post-incision Antimicrobial Wash vs C. Acnes in Shoulder Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Dermis and Incidence of Cutibacterium Acnes During Shoulder Arthroplasty: A Randomized Controlled Trial

Quick Facts

Study Start:2025-05-05
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06831422

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Indicated and scheduled for primary shoulder arthroplasty.
  2. * Chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, rotator cuff arthropathy,
  3. * Ability to read and understand English
  4. * Age ≥18 years
  5. * Patient failed ≥6 weeks of conservative treatment, which included non-steroidal anti-inflammatory drugs (NSAIDS)
  1. * Patient with history of prior native shoulder septic arthritis or infection
  2. * Prior surgery of affected shoulder
  3. * Proximal Humerus Fracture
  4. * Active infection
  5. * Cancer
  6. * Autoimmune and rheumatologic disorders, including rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus
  7. * History of allergic reaction to citric acid-derived products

Contacts and Locations

Study Contact

Chimdindu Obinero, BS
CONTACT
678-230-8592
cobiner1@hfhs.org
Jared Mahylis, MD
CONTACT
313-916-2181
jmahyli1@hfhs.org

Study Locations (Sites)

Henry Ford Health
Detroit, Michigan, 48202
United States

Collaborators and Investigators

Sponsor: Henry Ford Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-05
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-05-05
Study Completion Date2027-09

Terms related to this study

Keywords Provided by Researchers

  • Shoulder Arthroplasty
  • Antimicrobial
  • Post-incision wash
  • C. Acnes

Additional Relevant MeSH Terms

  • Shoulder Arthroplasty
  • Positive C. Acnes Culture