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Study on Reducing Cutibacterium acnes in Shoulder Surgery for Men Using Benzoyl Peroxide and Ethanol-Povidone Iodine Combination

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What is this study about?

This clinical trial is focused on reducing the presence of a type of bacteria called Cutibacterium acnes, which can cause infections during shoulder replacement surgery. The study involves male patients undergoing shoulder arthroplasty, a procedure to replace or repair the shoulder joint. The trial aims to evaluate the effectiveness of a topical treatment using a gel containing benzoyl peroxide at a concentration of 5%. This gel is applied to the skin in the area where the surgical incision will be made, for five days before the surgery.

In addition to the benzoyl peroxide gel, the study also uses a solution called Betadine, which contains ethanol and povidone-iodine. This solution is applied to the skin as an antiseptic to further reduce bacterial presence. The purpose of the study is to determine if these treatments can effectively lower the amount of Cutibacterium acnes on the skin and in deeper tissues, potentially reducing the risk of infection during and after the surgery.

Participants in the study will be divided into two groups: one group will receive the benzoyl peroxide treatment, and the other will serve as a control group. The study will monitor the number of positive bacterial samples from the skin and deeper tissues before and after the application of the antiseptic solution. The trial will also assess the skin’s tolerance to the treatments, looking for any signs of irritation or other reactions. The study will continue to follow participants for up to two years after their shoulder surgery to monitor for any infections related to Cutibacterium acnes.

1 joining the study

Upon joining the study, ensure that all eligibility criteria are met. These include being a male adult patient, having no history of surgical intervention on the operated shoulder, and being managed for specific types of shoulder arthroplasty. Consent must be informed and written.

2 preparation phase

During the 5 days before the shoulder surgery, apply a topical treatment containing 5% benzoyl peroxide to the surgical skin incision area. This is a gel applied to the skin to help reduce the bacterial load of Cutibacterium acnes.

3 surgery day

On the day of the surgery, the skin will be prepared using an antiseptic solution containing 5% alcoholic iodine povidone. This solution is applied to the skin to further reduce bacteria before the surgical incision.

4 post-surgery monitoring

After the surgery, samples will be taken to evaluate the presence of Cutibacterium acnes bacteria. This helps in assessing the effectiveness of the skin preparation methods used.

5 follow-up

Follow-up will continue to monitor for any signs of infection and to evaluate the skin’s tolerance to the topical treatment. This includes checking for irritation, redness, and peeling of the skin.

Who Can Join the Study?

  • Male patients only.
  • Adult patients are eligible. This means you must be 18 years or older.
  • You must not have had any previous surgery on the shoulder that will be operated on.
  • You are being treated for shoulder joint replacement surgery due to conditions like primary osteoarthritis, bone death (necrosis), a large tear in the shoulder’s rotator cuff, or an old fracture.
  • You must be part of a social security system, which means you have health insurance or similar coverage.
  • You must have given your informed and written consent, meaning you understand the study and agree to participate in writing.

Who Cannot Join the Study?

  • Patients who are female cannot participate in the study.
  • Patients who are not male cannot participate in the study.
  • Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
  • Patients who are part of a vulnerable population cannot participate. This means groups that might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Rennes Rennes France
Cshvvr Huefmfyryrg Ep Uozoacutvuutz Dv Ljempdg Limoges France
Colrzh Htiaiqvolkj Ryxaxsot Ukxrfawiprxcy Db Tzhwz Tours France
Ccrekh Hhifiikgwgh Rqrtlqas Dqkktxovnktbjb Angers France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
19.06.2020

Trial locations

Investigated drugs:

Benzoyl Peroxide is a topical treatment used in this clinical trial. It is applied directly to the skin in the area where surgery will take place. The main purpose of using benzoyl peroxide is to reduce the number of bacteria, specifically Cutibacterium acnes, on the skin. This is important because having fewer bacteria on the skin can help lower the risk of infection during and after surgery. In this trial, patients apply the treatment daily for five days before their shoulder surgery to see if it effectively reduces the bacteria in the skin. This helps ensure a safer surgical procedure by minimizing potential complications from bacterial infections.

Investigated diseases:

Cutibacterium acnes infection in shoulder arthroplasty – This condition involves the presence of the bacterium Cutibacterium acnes in the area of a shoulder joint replacement. The bacterium is commonly found on the skin and can enter the body during surgical procedures. Once inside, it can cause an infection that may lead to inflammation and discomfort in the affected area. The infection can progress slowly, often making it difficult to detect immediately. Over time, it may result in complications related to the shoulder prosthesis, such as loosening or failure of the implant. The progression of the infection can vary, with some cases remaining mild while others become more severe.

Trial ID:
2024-515584-56-00
Protocol code:
RC19_0042
NCT ID:
NCT04028401
Trial Phase:
Therapeutic confirmatory (Phase III)

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