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Acne crème to Reduce Propionibacterium Acnes Load in Primary Shoulder Surgery

NCT03949751 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-06-09

No results posted yet for this study

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.

Conditions

  • Shoulder Infections

Interventions

DRUG

Acne Crème Plus

The study specific intervention product is a combination of Benzoylperoxid and Miconazolnitrat (Widmer Acne Crème Plus, 47033 Swissmedic) to apply daily in the evening on 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. The application should be done regularly for 7 days before shoulder surgery. The study specific intervention product is authorized by Swissmedic for use in the treatment of acne and is used standardly in clinical practice.

Sponsors & Collaborators

  • Balgrist University Hospital

    lead OTHER

Principal Investigators

  • Samy Bouaicha, PD Dr.med. · Balgrist University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-04-27
Completion
2020-05-23

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03949751 on ClinicalTrials.gov