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Antibacterial Agent

Benzyl Peroxide for Shoulder Replacement Surgery

N/A

Waitlist Available

Research Sponsored by Albany Medical College

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 14 days in culture

Awards & highlights

Study Summary

This trial is testing if preoperative blue light phototherapy and benzoyl peroxide washes can decrease the number of Cutibacterium acnes (formerly Propionibacterium acnes) bacteria on the skin and reduce the risk of shoulder prosthetic joint infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 14 days in culture

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~14 days in culture

This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days in culture for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of total culture positivity during shoulder arthroplasty

Secondary outcome measures

Correlation of the rate of superficial culture positivity and the rate deep culture positivity during shoulder arthroplasty

Trial Design

3Treatment groups

Experimental Treatment

Group I: ControlExperimental Treatment1 Intervention

Standard preparation of the surgical site without P. acnes pretreatment

Group II: BPO and PhototherapyExperimental Treatment2 Interventions

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.

Group III: BPO GroupExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blue Light Phototherapy

2019

N/A

~120

Benzyl Peroxide

2019

N/A

~120

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkOTHER

243 Previous Clinical Trials

59,244 Total Patients Enrolled

Albany Medical CollegeLead Sponsor

91 Previous Clinical Trials

11,377 Total Patients Enrolled

Ian D Hutchinson, MDStudy DirectorAlbany Medical College

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum participant capacity for this research project?

"Affirmative. According to clinicaltrials.gov, this medical research project is actively accepting participants having first been posted on January 10th 2019 and last updated June 27th 2022. A total of 120 individuals at two different sites are needed for the trial's completion."

Answered by AI

Are there any available slots for participants in this trial?

"Affirmative. Evidenced by the clinicaltrials.gov database, this medical research is presently recruiting participants; it was initially posted on October 10th 2019 and has since been updated as recently as June 27th 2022. 120 individuals are being enrolled at two different sites."

Answered by AI

Recent research and studies

Dermatology and TherapyJournal

Optimizing Non-antibiotic Treatments for Patients with Acne: A Review

Canavan, Theresa N., Edward Chen, and Boni E. Elewski. 2016. “Optimizing Non-antibiotic Treatments for Patients with Acne: A Review”. Dermatology and Therapy. Springer Science and Business Media LLC. doi:10.1007/s13555-016-0138-1.

The Journal of Bone and Joint Surgery-American VolumeJournal

Efficacy of Surgical Preparation Solutions in Shoulder Surgery

Saltzman, Matthew D, Gordon W Nuber, Stephen M Gryzlo, Geoffrey S Marecek, and Jason L Koh. 2009. “Efficacy of Surgical Preparation Solutions in Shoulder Surgery”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.h.00768.

The Journal of Bone and Joint Surgery-American VolumeJournal

Prognostic Factors for Bacterial Cultures Positive for Propionibacterium Acnes and Other Organisms in a Large Series of Revision Shoulder Arthroplasties Performed for Stiffness, Pain, or Loosening

Pottinger, Paul, Susan Butler-Wu, Moni Blazej Neradilek, Andrew Merritt, Alexander Bertelsen, Jocelyn L Jette, Winston J Warme, and Frederick A Matsen III. 2012. “Prognostic Factors for Bacterial Cultures Positive for Propionibacterium Acnes and Other Organisms in a Large Series of Revision Shoulder Arthroplasties Performed for Stiffness, Pain, or Loosening”. The Journal of Bone and Joint Surgery-american Volume. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.k.00861.

The Journal of Bone and Joint Surgery-American VolumeJournal