Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06831422

Application of a Novel Antimicrobial Wash Versus Hydrogen Peroxide Versus Povidone-iodine to the Skin During Shoulder Replacement Surgery to Study Cutibacterium Acnes Infection Rates

Led by Henry Ford Health System · Updated on 2025-06-04

150

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

Sponsors

H

Henry Ford Health System

Lead Sponsor

N

Next Science TM

Collaborating Sponsor

AI-Summary

What this Trial Is About

This trial studies adults undergoing primary shoulder replacement surgery to compare the effects of different post-incision antimicrobial washes on the presence of Cutibacterium acnes (C. Acnes) bacteria. The goal is to find out whether applying these solutions after the initial incision can reduce positive C. Acnes cultures, which are linked to infections. Participants are adults with shoulder conditions like severe osteoarthritis or rotator cuff arthropathy who have not improved after conservative treatment. Participants are randomly assigned to one of four groups: Xperience Antimicrobial Wash, 3% hydrogen peroxide, 10% povidone-iodine (betadine), or no post-incision treatment (control). Each antimicrobial is applied along the entire dermis with a soaked surgical sponge right after the initial incision. The control group does not receive any dermal treatment before bacterial cultures are collected. During the study, cultures are taken from the surgical site before and after incision, the shoulder joint, and the operating room air. These cultures are monitored daily up to 18 days after surgery for C. Acnes. Patients have follow-up visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year to assess wound healing and complications. Data from medical records and clinical evaluations are collected and analyzed to understand the treatment effects and any surgical complications.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Scheduled for primary shoulder replacement surgery
  • Diagnosed with chronic severe glenohumeral osteoarthritis, avascular necrosis, post traumatic osteoarthritis, or rotator cuff arthropathy
  • Able to read and understand English
  • Age 18 years or older
  • Failed at least 6 weeks of conservative treatment including anti-inflammatory drugs
Not Eligible

You will not qualify if you...

  • History of prior infection or septic arthritis in the affected shoulder
  • Previous surgery on the shoulder to be treated
  • Proximal humerus fracture
  • Active infection
  • Cancer
  • Autoimmune or rheumatologic disorders such as rheumatoid arthritis, psoriatic arthritis, or lupus
  • History of allergy to citric acid-derived products

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo shoulder replacement surgery with application of one of three antimicrobial washes or no treatment to the dermal layer during surgery. Cultures are collected from the surgical site, incision site, shoulder joint, and room air during the procedure.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 1 year

Participants are monitored for the presence of C. Acnes through cultures for up to 18 days after surgery. Clinical evaluations of wound healing and complications are conducted at postoperative clinic visits.

Clinic visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-surgery

Trial Site Locations

Total: 1 location

1

Henry Ford Health

Detroit, Michigan, United States, 48202

Actively Recruiting

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Research Team

C

Chimdindu Obinero, BS

J

Jared Mahylis, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

4

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