Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery

Not Applicable

• Conditions: Rotator Cuff Tear Arthropathy; Spine Degeneration
• Interventions: Drug: Benzoyl peroxide

• Registration Number: NCT05355844
• Lead Sponsor: Hospital del Mar

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.

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-26
• Study First Submitted QC: 2022-04-26
• Last Update Submitted: 2022-04-26
• Study Start: 2022-05
• Study First Posted: 2022-05-02
• Last Update Posted: 2022-05-02
• Primary Completion: 2023-05
• Study Completion: 2023-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients without Benzoyl peroxide	Benzoyl peroxide	-
Patients with Benzoyl peroxide	Benzoyl peroxide	-

Primary Outcome Measures

Name	Time	Method
Cutibacterium acnes	2 weeks	isolation of Cutibacterium acnes in the deep tissues