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NCT05355844 Clinical Trial

Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery

Rotator Cuff Tear Arthropathy Clinical Trial

Official title:
Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05355844
Other study ID # 2022/10272
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 2022
Est. completion date November 2023

Study information
Verified date April 2022
Source Hospital del Mar
Contact Carlos Torrens, MD
Phone 003493674100
Email CTorrens@psmar.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

Shoulder prosthetic surgery as well as interventional surgery on the spine are commonly contaminated by Cutibacterium Acnes. Although the significance of this contamination is unknown, it represents a cause for concern since in some patients, contaminating Cutibacterium Acnes from surgery may develop long-term infection of the implant. Unlike knee and hip surgeries, where the most common infection-causing germs are Staphylococcus aureus, in shoulder and spine surgery, Cutibacterium Acnes represents one of the germs most frequently associated with infections. peri implant. Skin preparation with chlorhexidine as well as antibiotic prophylaxis with cefazolin have been shown to be ineffective in eradicating Cutibacterium Acnes. Recently, different studies support the use of benzoyl peroxide in topical application, to reduce the load of Cutibacterium acnes on the skin. Despite this, it has not been shown to reduce the rate of infection, nor to reduce the phylotypes of Cutibacterium acnes associated with peri-implant infections (IA, IB and II). 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 200
Est. completion date November 2023
Est. primary completion date May 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - patients > 18 yrs. - Primary prosthetic shoulder surgery. - Instrumented primary surgery of the spine. Exclusion Criteria: - active infection. - previous surgeries. - interventionism prior to surgery in the last 6 months (infiltrations, arthro-CT, arthro-MRI)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Benzoyl peroxide
Benzoyl peroxide application in the incision area before surgery

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital del Mar

Outcome
Type Measure Description Time frame Safety issue
Primary Cutibacterium acnes isolation of Cutibacterium acnes in the deep tissues 2 weeks
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