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

August 28, 2023 updated by: Joseph Zimmerman, MD, Albany Medical College

The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty; a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study hypotheses will be tested using a prospective randomized-controlled trial of the effect of combination blue spectrum phototherapy and benzoyl peroxide on P. acnes at the shoulder arthroplasty surgical site. Accordingly, it will conform to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Subjects presenting to our Orthopaedic department will be randomized to one of three study arms:

  1. Control: standard preparation of the surgical site without P. acnes pretreatment
  2. BPO group: Pretreatment with 2 days of washes prior to surgery
  3. BPO and Phototherapy: 2 days of washes with 3 treatments of blue spectrum phototherapy

Patients will be seen at our office will be consented and recruited into the study. Subjects will have standard of care evaluation including: radiographs, preoperative labs and clearances. If selected and agreeable, treatment with phototherapy will involve the application of three sessions lasting 3 minutes preoperatively; the sessions will be conducted by the patient at home for two days prior to surgery and in the preoperative holding area. During each application, protective eyewear will be used. For patients in the BPO groups, a 10% benzoyl peroxide wash will be used globally on the operative shoulder and axilla during showering. An educational leaflet will outline the surgical field in addition to temporary demarcation at the time of BPO pickup at the office. Additional tests, imaging or procedures will be at the discretion of the treating physician and documented during the study. During the postoperative visit at 10-14 days, the post operative wound will be assessed in the standard manner. Final culture results will be recorded for each patient and documented in the study database.

  • The surgical site will be prepared in usual fashion with Chloroprep and the patients will receive preoperative Cefazolin (or vancomycin based on penicillin allergy)
  • Following both draping and skin incision, the surgeons gloves will be changed; any blades used in the skin incision will also be discarded
  • Intraoperative cultures will be taken following established protocols, published in the literature: an excisional biopsy 1cm long and 3mm wide will be taken from the medial wound edge at the time of incision; the superficial dermal tissue will be swabbed immediately after the biopsy is taken and finally, a swab of the glenohumeral (shoulder) joint will be performed prior to closure at the end of the procedure and after insertion of the implant.
  • Specimens will be transported to the laboratory adjoining the operating room at our institution within 1 hour of harvesting and processed by microbiology technicians in a laminar flow biological safety hood. Tissue from the skin edge will be homogenized in sterile saline solution and plated on media: blood agar, chocolate agar, Brucella agar, MacConkey agar, Columbia nalidixic acid agar and phenylethyl alcohol anaerobic blood agar. All media will be incubated at 37C for 14 days.
  • Specimens will be incubated for 14 days in aerobic and anaerobic media to detect P acnes and other organisms
  • Culture results will not be discussed with patients; patients will be consented to not know their results as they are not clinically significant
  • Prophylactic antibiotic treatment of positive cultures will not be performed in any case.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10021
        • Hospital for Special Surgery

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.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • All patients presenting to the practice that require a shoulder arthroplasty procedure
  • English fluency and literacy
  • Able to provide informed consent
  • Older than 18 years of age
  • Surgical indications including: primary arthritis, rotator cuff arthropathy, post-traumatic arthritis
  • Primary total shoulder, hemiarthroplasty, primary reverse total shoulder or shoulder resurfacing

Exclusion Criteria

  • Subjects who have had a prior infection of the affected shoulder joint
  • Recent steroid injection to the shoulder in the past 6 months
  • Previous open or arthroscopic procedure of the shoulder joint
  • Recent antibiotic use (within 90 days)
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control
Standard preparation of the surgical site without P. acnes pretreatment
Other: Control
Standard surgical site preparation with no P. acnes pretreatment
Experimental: BPO Group
Pretreatment with 10% Benzoyl peroxide body wash for two consecutive days of washes prior to surgery at home. The anterior shoulder area is wet before treatment; the wash is massaged in for 20 seconds producing a lather and washed off, patting dry.
Drug: Benzyl Peroxide
Benzyl peroxide wash to be used preoperatively during showering to the operative shoulder site.
Other Names:
  • BPO
Experimental: BPO and Phototherapy
2 days of benzoyl peroxide washes and 3 treatments of blue light phototherapy. Pretreatment with 10% Benzoyl peroxide body wash for two consecutive days of washes prior to surgery at home. The anterior shoulder area is wet before treatment; the wash is massaged in for 20 seconds producing a lather and washed off, patting dry. The blue light phototherapy is administered to the shoulder for 3 minutes on three occasions; 2 days before, the day before surgery and in the preoperative area by the patient.
Drug: Benzyl Peroxide
Benzyl peroxide wash to be used preoperatively during showering to the operative shoulder site.
Other Names:
  • BPO
Device: Blue Light Phototherapy
Phototherapy in the blue light spectrum
Other Names:
  • Phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of total culture positivity during shoulder arthroplasty
Time Frame: 14 days in culture
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.
14 days in culture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of the rate of superficial culture positivity and the rate deep culture positivity during shoulder arthroplasty
Time Frame: 14 days in culture
To investigate the correlation between the rate of positive deep cultures in samples taken at the end of surgery (1 deep swab) and the rate of superficial culture positivity of samples taken at the beginning of the case (incisional biopsy and superficial dermal swab). It is theorized that P. Acnes in the superficial wound is propagated to the deeper tissues during surgery, impacting deep culture rates and possibly contributing to prosthetic joint infection risk.
14 days in culture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albany Medical College

Collaborators

Hospital for Special Surgery, New York

Investigators

  • Study Director: Ian D Hutchinson, MD, Albany Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

July 22, 2019

First Submitted That Met QC Criteria

September 30, 2019

First Posted (Actual)

October 2, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5316

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Shoulder Arthroplasty

Clinical Trials on Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe