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

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ClinicalTrials.gov Identifier: NCT04112407
Recruitment Status : Not yet recruiting
First Posted : October 2, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph Zimmerman, MD, Albany Medical College

Brief 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.

Condition or disease Intervention/treatment Phase
Shoulder Arthroplasty Device: Blue Light Phototherapy Drug: Benzyl Peroxide Other: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Effect of Pretreatment for Propionibacterium Acnes on Surgical Site Burden in Shoulder Arthroplasty; a Pilot Study
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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 Name: 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.
Device: Blue Light Phototherapy
Phototherapy in the blue light spectrum
Other Name: Phototherapy

Drug: Benzyl Peroxide
Benzyl peroxide wash to be used preoperatively during showering to the operative shoulder site.
Other Name: BPO




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04112407


Locations
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United States, New York
Albany Medical Center Not yet recruiting
Albany, New York, United States, 12208
Contact: Ian Hutchinson, MD    518-262-4000    hutchii@amc.edu   
Contact: AMC Office for Research    518-262-2475    IRBoard@amc.edu   
Principal Investigator: Joseph Zimmerman, MD         
Sub-Investigator: Ian Hutchinson, MD         
Sponsors and Collaborators
Albany Medical College
Investigators
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Study Director: Ian D Hutchinson, MD Albany Medical College

Publications of Results:

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Responsible Party: Joseph Zimmerman, MD, Attending Orthopaedic Surgeon, Department of Surgery, Division of Orthopaedic Surgery,, Albany Medical College
ClinicalTrials.gov Identifier: NCT04112407     History of Changes
Other Study ID Numbers: 5316
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Joseph Zimmerman, MD, Albany Medical College:
P. Acnes
shoulder arthroplasty
blue light therapy
benzoyl peroxide
Additional relevant MeSH terms:
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Benzoyl Peroxide
Dermatologic Agents