Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery

NCT ID: NCT05355844

Last Updated: 2022-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2023-11-30

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.

Conditions

Rotator Cuff Tear Arthropathy; Spine Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patients without Benzoyl peroxide

Group Type: SHAM_COMPARATOR

Benzoyl peroxide

Intervention Type: DRUG

Benzoyl peroxide application in the incision area before surgery

Patients with Benzoyl peroxide

Group Type: EXPERIMENTAL

Benzoyl peroxide

Intervention Type: DRUG

Benzoyl peroxide application in the incision area before surgery

Interventions

Benzoyl peroxide

Benzoyl peroxide application in the incision area before surgery

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital del Mar

OTHER

Sponsor Role: lead

Responsible Party

Carlos Torrens

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Carlos Torrens, MD

Role: CONTACT

CTorrens@psmar.cat

003493674100 ext. 4201

Other Identifiers

2022/10272

Identifier Type: -

Identifier Source: org_study_id