In short
There is currently 1 ongoing clinical trial investigating ways to reduce Cutibacterium acnes infection in patients undergoing shoulder replacement surgery. This trial focuses on a preventive approach using topical treatments applied to the skin before surgery to lower the risk of bacterial infection during and after the procedure.
Clinical trial locations
Study on Reducing Cutibacterium acnes in Shoulder Surgery for Men Using Benzoyl Peroxide and Ethanol-Povidone Iodine Combination
This trial is investigating whether a combination of skin treatments can reduce the presence of Cutibacterium acnes bacteria in men undergoing shoulder replacement surgery. The bacterium is commonly found on the skin and can enter the body during surgical procedures, potentially causing infections that may affect the success of the implant.
Who can participate:
- Male patients aged 18 years or older
- Men scheduled for shoulder joint replacement due to conditions such as primary osteoarthritis, bone death, large rotator cuff tears, or old fractures
- Patients who have not had any previous surgery on the shoulder being operated on
- Those with health insurance or social security coverage
- Patients who can provide informed written consent
Who cannot participate:
- Female patients
- Patients outside the specified age range
- Individuals who are part of vulnerable populations requiring special protection
What the trial involves:
The main focus of this study is to determine whether applying a benzoyl peroxide gel (5% concentration) to the skin for five days before surgery can effectively reduce bacterial levels. The gel is applied daily to the area where the surgical incision will be made. On the day of surgery, an additional antiseptic solution called Betadine, which contains ethanol and povidone-iodine, is applied to further reduce bacteria.
Participants will be divided into two groups: one receiving the benzoyl peroxide treatment and another serving as a control group. During and after surgery, samples will be taken from the skin and deeper tissues to measure bacterial levels and assess whether the treatment successfully reduced the amount of Cutibacterium acnes present. The study will also monitor the skin for any signs of irritation, redness, or peeling caused by the treatment.
Investigational treatment:
The trial uses benzoyl peroxide, a topical antibacterial agent that works by releasing oxygen, which kills bacteria on the skin. By applying this treatment before surgery, researchers hope to minimize the risk of infection during and after the shoulder replacement procedure.
Follow-up:
Participants will be monitored for up to two years after their surgery to check for any infections related to Cutibacterium acnes and to evaluate the long-term success of the preventive treatment approach.
Summary
Currently, there is one active clinical trial addressing Cutibacterium acnes infection in the context of shoulder surgery, taking place in France. This trial is exclusively for male patients and focuses on prevention rather than treatment of existing infections. The approach involves using benzoyl peroxide gel as a pre-surgical preparation to reduce bacterial load on the skin, combined with standard antiseptic procedures on the day of surgery. The study reflects growing interest in preventing surgical site infections caused by this common skin bacterium, particularly in orthopedic procedures where infections can have serious consequences for implant success. The two-year follow-up period demonstrates a commitment to understanding long-term outcomes and the effectiveness of this preventive strategy.
