Skin Prep to Reduce Postoperative Shoulder Infection
Adjusting Skin Prep to Decrease Risk of P. Acnes Related Shoulder Infection
1 other identifier
interventional
80
1 country
1
Brief Summary
Propionibacterium acnes is the most common pathogen identified from a surgical site infection in the shoulder. Standard skin preps do not prevent this type of infection. Patients will undergo either a chlorhexidine or benzoyl peroxide prep in days leading up to surgery. Bacterial burden will be determined at the time of surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2015
CompletedFirst Posted
Study publicly available on registry
July 29, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedResults Posted
Study results publicly available
January 29, 2020
CompletedFebruary 11, 2020
January 1, 2020
2.9 years
July 23, 2015
November 4, 2019
January 29, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Skin Swab and Culture With Colony Forming Units (CFUs)
Preoperative Cutibacterium acnes shoulder burden. Skin cultures of both shoulders were obtained via a detergent scrub technique the day of surgery at anterior, lateral, and posterior sites and the axilla.
At time of surgery
Secondary Outcomes (1)
Surgical Site Infection That Requires Antibiotics
At one year
Study Arms (2)
Chlorhexidine
ACTIVE COMPARATORA preoperative Chlorhexidine gluconate solution 4.0% (i.e Hibiclens)
Benzoyl Peroxide
EXPERIMENTALA preoperative 5% benzoyl peroxide wash prep (i.e. Brevoxyl-4 and Brevoxyl-8)
Interventions
Eligibility Criteria
You may qualify if:
- Age \>18
- Indicated for shoulder surgery
You may not qualify if:
- History of previous shoulder infection
- Allergy to Chlorhexidine or benzoyl peroxide
- Current use of anti-acne medicine around the shoulder
- Patient is pregnant or concerned about pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland Midtown Hospital
Baltimore, Maryland, 21201, United States
Results Point of Contact
- Title
- Dr. Mohit Gilotra
- Organization
- University of Maryland Baltimore
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Orthopaedics
Study Record Dates
First Submitted
July 23, 2015
First Posted
July 29, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
February 11, 2020
Results First Posted
January 29, 2020
Record last verified: 2020-01