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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05355844
Enrollment
200
Registered
2022-05-02
Start date
2022-05-31
Completion date
2023-11-30
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Tear Arthropathy, Spine Degeneration

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.

Detailed 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.

Interventions

Benzoyl peroxide application in the incision area before surgery

Sponsors

Hospital del Mar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Cutibacterium acnes2 weeksisolation of Cutibacterium acnes in the deep tissues

Contacts

Primary ContactCarlos Torrens, MD
CTorrens@psmar.cat003493674100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026