TerminatedNot Applicable

Preoperative Jumpstart for Decolonization of P. Acnes

Stopped: Unexpected culture contamination potentially due to a testing error

United States17 participantsStarted 2018-11-01

Plain-language summary

The objective of the study is to evaluate the efficacy of preoperative treatment with a novel, wireless, low-level microcurrent-generating antimicrobial device (brand name: JumpStart) in preventing the spread of Propionibacterium acnes in patients receiving open or arthroscopic shoulder surgery.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 years old or older * Scheduled to receive open or arthroscopic shoulder surgery Exclusion Criteria: * 17 years old or younger * Pregnant women * Prisoners * Non-English speaking or unable to understand consent * History of any prior shoulder surgery * History of previous shoulder infection or clinical signs of preoperative infection * History of taking any antibiotic(s) within 4 weeks prior to the scheduled shoulder surgery * Active acne or skin inflammatory disorders (psoriasis, eczema, etc) in the shoulder

What they're measuring

Presence of Propionibacterium Acnes in Skin Biopsies During Surgery

Timeframe: 7 days post-biopsy

Trial details

NCT IDNCT03466658

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-01

Results submitted2019-11-22

View on ClinicalTrials.gov More Shoulder Arthropathy Associated With Other Conditions trials