A Randomized Phase 2 Trial of Antibiotic Prophylaxis Versus No Intervention for Muscle Biopsy in A Neurology Department

Nakahara, Keiichi Department of Neurology, Graduate School of Medical Sciences, Kumamoto University

Ikeda, Tokunori Department of Clinical Investigation, Kumamoto University Hospital

Takamatsu, Koutaro Department of Neurology, Graduate School of Medical Sciences, Kumamoto University

Tawara, Nozomu Department of Neurology, Graduate School of Medical Sciences, Kumamoto University

Hara, Kentaro Department of Neurology, Graduate School of Medical Sciences, Kumamoto University

Enokida, Yuki Department of Pharmacy, Kumamoto University Hospital

Tanoue, Naomi Department of Pharmacy, Kumamoto University Hospital

Narita, Sawana Department of Clinical Investigation, Kumamoto University Hospital

Fujii, Akiko Department of Clinical Investigation, Kumamoto University Hospital

Yamanouchi, Yoshinori Department of Clinical Investigation, Kumamoto University Hospital

Morinaga, Jun Department of Clinical Investigation, Kumamoto University Hospital

Yamashita, Satoshi Department of Neurology, Graduate School of Medical Sciences, Kumamoto University

Publication Date

2020-06

Abstract

Muscle biopsy can be used to confirm the diagnosis of neuromuscular diseases. However, it is unclear whether antibiotic prophylaxis prior to muscle biopsy is needed to prevent surgical site infection (SSI). We are conducting a phase 2, single-center, open-labeled, prospective randomized trial to clarify the need for antibiotic prophylaxis in patients at low risk for SSI undergoing muscle biopsy. Patients will be randomized to an antibiotic prophylaxis group or a control group, and the incidence of SSI will be compared between the groups. Our findings will clarify the need for antibiotic prophylaxis in this patient population.

Document Type

Clinical Study Protocol

Keywords

muscle biopsy

antibiotic prophylaxis

Link to PubMed

32577026

ISSN

0386-300X

NCID

AA00508441

NAID