Cutibacterium Acnes: Triple Prevention in Shoulder Operations (C3PO)

February 6, 2024 updated by: Clinique Générale dAnnecy

Triple Prevention Against Cutibacterium Acnes Using Benzoyl Peroxide Preparation in Addition to Pre-operative Cutaneous and Subcutaneous Iodine in Shoulder Surgery; a Single-blinded, Randomized, Controlled Trial.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients will be contacted for participation (see Eligibility Criteria). If subjects meet the inclusion criteria, patients will receive information regarding the study outline, associated risks, and subject rights. Informed consent must be freely given, specific, unambiguous, and may be withdrawn at any time. Subjects must be legally capable of providing consent. Consent will be and recorded in writing and stored for the duration of the study. The target for inclusion was set at 52 patients in each group, of each group 26 will be arthroscopic and 26 open surgery.

Patients will be divided into three groups of equal size:

  • Triple-prevention: Benzoyl peroxide at home, subcutaneous iodine, and cutaneous iodine.
  • Double-prevention: Cutaneous and subcutaneous iodine.
  • Single-prevention (control group): cutaneous iodine.

Simple block randomisation will be used to prevent chronological bias and ensure equal group size. Treatments will be allocated with a 1:1:1 ratio using a block size of 12. Randomisation will be stratified by open or arthroscopic surgery to ensure an equal number in all three groups (3x2x26 patients) Random treatment allocation numbers will be generated and blinded, to be revealed after inclusion.

Benzoyl peroxide:

Patients will be instructed to apply and rub in a 5-cm strip of 5% benzoyl peroxide gel to the shoulder on dry skin in the morning and evening 2 days prior to surgery, 1 day before surgery, and a fifth time in the morning on the day of surgery.

Cutaneous iodine:

Standard pre-operative preparation including cutaneous disinfection with alcoholic iodine, sterile drapes.

Subcutaneous iodine:

Open surgery: after incision down to the fascia of the muscle layer, preparation of the whole subcutaneous layer with povidone-iodine solution will be performed and left acting during 60 seconds before full aspiration and lavage in order to not have swabs drained in povidone-iode (as it could continue to act as antiseptic during culture).

For arthroscopic procedures the disinfection and swab collection protocol will be performed when creating the first portal.

Bacterial culture swabs (n=9) will be taken during surgery from the patients' skin (before disinfection with iodine), subcutaneous tissue (after disinfection if randomised for subcutaneous disinfection), muscular layer, intra-articular/layer of the intervention (for example in case of clavicle surgery from the clavicle), surgeon's glove, outside scalpel, inside scalpel, and the retractors. For the swabs in the operative field, the applicable field is to be swabbed fully for 3 seconds. Each surgeon will follow the clear swab instructions from the microbiologist in order to obtain reliable cultures. Cultures will be analysed by the hospital's medical microbiological laboratory following standard protocol including a standard incubation time of 14 days. Treatment arm will be blinded for the laboratory employees.

Culture positivity between the groups will be analysed using chi-square tests for each culture location. In addition, a two-way ANOVA test will be performed to assess total number of positive cultures per patient. Furthermore, logistic regression models will be used to adjust for several potential confounding factors depending on the number of positive tests in the sample.

Study Type

Interventional

Enrollment (Estimated)

156

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Indication for all types of surgery at the shoulder joint, acromioclavicular joint, or clavicle, including arthroscopic and open surgery.

Exclusion Criteria:

  • Previous shoulder surgery;
  • History of shoulder infection;
  • Antibiotic treatment in the last 6 weeks;
  • Allergy or hypersensitivity to one of the disinfecting agents;
  • Patients with laboratory values consistent with a current infection (C-reactive protein, erythrocyte sedimentation rate, leukocyte count).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control/Single prevention
Standard pre-operative cutaneous disinfection using iodine.
Experimental: Double prevention
Pre-operative cutaneous and subcutaneous disinfection using iodine.
Procedure: Subcutaneous disinfection
After incision, the subcutaneous tissue will be disinfected for 60 seconds using iodine before continuing the surgical approach.
Experimental: Triple prevention
Pre-operative cutaneous and subcutaneous disinfection using iodine and preparation of the skin with benzoyl peroxide in the days prior to surgery.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cutibacterium Acnes positivity
Time Frame: 14 days
Rate of culture positivity for Cutibacterium Acnes of swabs taken during surgery
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Culture positivity with other bacteria
Time Frame: 14 days
Rate of culture positivity for other types of bacteria of swabs taken during surgery
14 days
Adherence to pre-operative protocol
Time Frame: 1 day
Completeness percentage of the pre-operative skin preparation protocol as reported by participants the morning of the intervention
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse reaction to Benzoyl Peroxide
Time Frame: 1 day
Number and type of adverse reactions of any type to Benzoyl Peroxide reported by participants
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Générale dAnnecy

Collaborators

Centre Hospitalier Annecy Genevois

Investigators

  • Principal Investigator: Geert A Buijze, MD, PhD, Clinique Générale d'Annecy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

November 1, 2024

Study Registration Dates

First Submitted

January 18, 2023

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023C3PO-trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Surgical Site Infection

Clinical Trials on Subcutaneous disinfection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe