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Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery

Primary Purpose

Rotator Cuff Tear Arthropathy, Spine Degeneration

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Benzoyl peroxide
Sponsored by
Hospital del Mar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rotator Cuff Tear Arthropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Experimental

    Arm Label

    Patients without Benzoyl peroxide

    Patients with Benzoyl peroxide

    Arm Description

    Outcomes

    Primary Outcome Measures

    Cutibacterium acnes
    isolation of Cutibacterium acnes in the deep tissues

    Secondary Outcome Measures

    Full Information

    First Posted
    April 26, 2022
    Last Updated
    April 26, 2022
    Sponsor
    Hospital del Mar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05355844
    Brief Title
    Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery
    Official Title
    Can Benzoyl Peroxide Decrease the Burden of Cutibacterium Acnes in Primary Spine and Shoulder Surgery? Prospective Randomized Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    November 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital del Mar

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Tear Arthropathy, Spine Degeneration

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients without Benzoyl peroxide
    Arm Type
    Sham Comparator
    Arm Title
    Patients with Benzoyl peroxide
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Benzoyl peroxide
    Intervention Description
    Benzoyl peroxide application in the incision area before surgery
    Primary Outcome Measure Information:
    Title
    Cutibacterium acnes
    Description
    isolation of Cutibacterium acnes in the deep tissues
    Time Frame
    2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carlos Torrens, MD
    Phone
    003493674100
    Ext
    4201
    Email
    CTorrens@psmar.cat

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Cutibacterium Acnes in Deep Tissues in Primary Spine and Shoulder Surgery

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