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Cutibacterium Acnes: Triple Prevention in Shoulder Operations

NCT05701475 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2025-12-04

No results posted yet for this study

Summary

Patients planned for shoulder surgery will be identified and contacted for participation. After informed consent is provided, patients will be randomised into one of three groups: pre-operative cutaneous disinfection with iodine (control group), pre-operative cutaneous and subcutaneous disinfection with iodine (double prevention), and pre-operative cutaneous and subcutaneous disinfection with iodine combined with a skin preparation protocol with benzoyl peroxide gel in the days prior to surgery (triple prevention). Bacterial cultures will be collected during surgery of the surgical field and tissue layers. Culture positivity for Cutibacterium Acnes will be compared between the groups as a primary outcome.

Conditions

  • Post-Operative Wound Infection
  • Surgical Site Infection

Interventions

PROCEDURE

Subcutaneous disinfection

After incision, the subcutaneous tissue will be disinfected for 60 seconds using iodine before continuing the surgical approach.

PROCEDURE

Benzoyl peroxide preparation

In the days prior to surgery, the skin will be prepared using Benzoyl Peroxide gel according to a standardised protocol.

Sponsors & Collaborators

  • Centre Hospitalier Annecy Genevois

    collaborator OTHER

  • Clinique Générale dAnnecy

    lead OTHER

Principal Investigators

  • Geert A Buijze, MD, PhD · Clinique Générale d'Annecy

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-18
Primary Completion
2024-12-28
Completion
2024-12-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701475 on ClinicalTrials.gov