Acne crème to Reduce Propionibacterium Acnes Load in Primary Shoulder Surgery
Status:
Completed
Trial end date:
2020-05-23
Target enrollment:
Participant gender:
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.