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Acne crème to Reduce Propionibacterium Acnes Load in Primary Shoulder Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949751
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Balgrist University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Shoulder Infections Drug: Acne Crème Plus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Investigator)
Masking Description: The institution has a standardized procedure for recruiting participants as participant studies are common. They will be preselected, based on the in- and exclusion criteria as mentioned above. If the match the inclusion criteria and do not meet the exclusion criteria, they will be informed, during the preoperative consultation by one of the study investigators, about the study, its nature, purpose, procedures involved, expected duration, participating investigators, potential risks and benefits and any potential discomfort the study could entail. The first 30 patients that can be selected through this procedure for the participation in the study will not get any therapy and therefore they will form the control group. The next 30 patients will get the therapy and so form the treatment group.
Primary Purpose: Treatment
Official Title: Can Propionibacterium Acnes Load in Primary Shoulder Surgery be Reduced With Preoperative Application of a Benzoylperoxid/Miconazolnitrat crème Additional to Standard Antibiotic Prophylaxis
Actual Study Start Date : November 1, 2018
Actual Primary Completion Date : April 27, 2020
Actual Study Completion Date : May 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
No Intervention: Control group
The participants of the control group will not get the local therapy in the investigator's preoperative consultation but they will need to give written consent for taking swabs for culture samples pre- and intraoperative.
Experimental: Therapy group
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.
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.
Other Name: Widmer Acne Crème Plus, 47033 (Swissmedic)




Primary Outcome Measures :
  1. Positive Propionibacterium acnes sample therapy group before therapy [ Time Frame: 1 day ]
    Number of positive culture samples for Propionibacterium acnes in patients undergoing first time open shoulder surgery in the therapy group at the time point before application of therapy.

  2. Positive Propionibacterium acnes sample control group before surgery [ Time Frame: 1 day ]
    Number of positive culture samples for Propionibacterium acnes in patients undergoing first time open shoulder surgery in the control group at the time point before application of therapy in the therapy Group.

  3. Change of positive Propionibacterium acnes sample therapy group after therapy [ Time Frame: Around 7 days ]
    Number of positive culture samples for Propionibacterium acnes in patients undergoing first time open shoulder surgery in the therapy group after application of therapy.

  4. Change of positive Propionibacterium acnes sample control group intraoperative [ Time Frame: Around 7 days ]
    Number of positive culture samples for Propionibacterium acnes in patients undergoing first time open shoulder surgery in the control group after application of therapy in the therapy group.


Secondary Outcome Measures :
  1. Change of positive Propionibacterium acnes in different layers [ Time Frame: Around 7 days ]
    Rate of positive cultures for Propionibacterium acnes in different layers (superficial, subcutaneous, deep layer)

  2. Change of positive Propionibacterium acnes gender-related [ Time Frame: Around 7 days ]
    Rate of positive cultures for Propionibacterium acnes in male versus female

  3. Change of positive Propionibacterium acnes age-related [ Time Frame: Around 7 days ]
    Rate of positive cultures for Propionibacterium acnes in younger versus older patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03949751


Locations
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Switzerland
University Hospital Balgrist
Zurich, Switzerland, 8008
Sponsors and Collaborators
Balgrist University Hospital
Investigators
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Principal Investigator: Samy Bouaicha, PD Dr.med. Balgrist University Hospital
Publications:
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Responsible Party: Balgrist University Hospital
ClinicalTrials.gov Identifier: NCT03949751    
Other Study ID Numbers: W728
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Balgrist University Hospital:
gram positive bacteria
Benzoylperoxid and Miconazolnitrat