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Shoulder Infections clinical trials

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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NCT ID: NCT03949751 Completed - Shoulder Infections Clinical Trials

Acne crème to Reduce Propionibacterium Acnes Load in Primary Shoulder Surgery

Start date: November 1, 2018
Phase: N/A
Study type: Interventional

60 patients undergoing first time open shoulder surgery (Latarjet, prosthesis) will be prospectively included in this study. The investigators will do a randomized controlled trial, choosing with a single-blinded protocol 30 patients for local therapy and other 30 patients as the control group without any treatment preoperative. In the preoperative consultation 30 patients will get Acne Crème Plus (Benzoylperoxid and Miconazolnitrat) to apply until operation (on average 7 days) after receiving written consent. The application should be done daily in the evening on the planned operative side covering the skin from the nipple-areola complex laterally to the medial margin of the scapula and from a horizontal line through the nipple-areola complex cranially over the shoulder and dorsally to the spina scapulae. 30 patients will be included in the control group. Those patients will not get the local therapy in the preoperative consultation but they will need to give written consent for taking swabs for culture samples pre- and intraoperative. In the operation room there will be done from each of the 60 patients a superficial skin swab before doing disinfection, a swab of the subcutaneous layer and a swab of the deep layer (joint capsule). All the three swabs from each of the 60 patients will be sent to Unilabs, Labor für Medizinische Analytik AG, Dübendorf, Switzerland to streak on agar plates to cultivate under anaerobic conditions for 14 days. Propionibacterium acnes will be identified by use of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry.