Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery
Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study
1 other identifier
interventional
200
0 countries
N/A
Brief Summary
Obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. Patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
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
April 26, 2022
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedFirst Posted
Study publicly available on registry
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedMay 2, 2022
April 1, 2022
1 year
April 26, 2022
April 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cutibacterium acnes
isolation of Cutibacterium acnes in the deep tissues
2 weeks
Study Arms (2)
Patients without Benzoyl peroxide
SHAM COMPARATORPatients with Benzoyl peroxide
EXPERIMENTALInterventions
Benzoyl peroxide application in the incision area before surgery
Eligibility Criteria
You may qualify if:
- patients \> 18 yrs.
- Primary prosthetic shoulder surgery.
- Instrumented primary surgery of the spine.
You may not qualify if:
- active infection.
- previous surgeries.
- interventionism prior to surgery in the last 6 months (infiltrations, arthro-CT, arthro-MRI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital del Marlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
April 26, 2022
First Posted
May 2, 2022
Study Start
May 1, 2022
Primary Completion
May 1, 2023
Study Completion
November 1, 2023
Last Updated
May 2, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share