Acne crème to Reduce Propionibacterium Acnes Load in Primary Shoulder Surgery

• Status: Completed
• Trial end date: 2020-05-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Balgrist University Hospital

Criteria

Inclusion Criteria:

• Patients undergoing first time open shoulder surgery (Latarjet, prosthesis)

• Male and female patients

• Age > 18 years

• Competent German language skills

• Written informed consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

• Previous enrollment into the current study,

• known or suspected non-compliance, drug or alcohol abuse,

• participation in another study with investigational drug within the 30 days preceding and during the present study,

• pregnancy or breast feeding (see chapter 3.7),

• preliminary shoulder surgeries,

• patients planned for an arthroscopic shoulder surgery,

• hypersensitivity to Benzoylperoxid or Miconazol,

• use of other acne preparations