Randomized clinical trial of antibiotic prophylaxis versus no intervention in muscle biopsy

Not Applicable

• Conditions: Patients with planning muscle biopsy

• Registration Number: JPRN-UMIN000034535
• Lead Sponsor: Kumamoto university

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-18
• Study Completion: 2023-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients who are not hospitalized in neurology 2) Less than 20 years old patients 3) Over 80 years old patients 4) Patients who are pregnant or might be pregnant 5) Immunocompromised patients 6) Patients with anamnesis of diabetes 7) Patients with over body mass index (BMI) of 25 kg/m2 8) Patients with experience of allergia for Cephalosporin antibiotic 9) Patients with anamnesis of anaphylactic shock for Cephalosporin 10) Patients with experience of hypersensitivity for local anesthetic such as anilide 11) Patients with over serum creatinine level 1.5 mg/dl 12) Patients with an infectious disease 13) Patient with treatment plan of immunosuppressive therapy immediately after muscle biopsy 14) Patients who have skin lesion at muscle biopsy planed region 15) Patients who are judged inappropriate for this trial by the attending physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The incidence and proportion of wound infection after muscle biopsy

Secondary Outcome Measures

Name	Time	Method
1) Background characteristics of patients 2) Adverse event of antibiotic 3) Wound score at the muscle biopsy performed region 4) characteristics of patients with wound infection 5) The relationship between days until the suture removal and the treatment with or without antibiotic 6) The relationship between body temperature and the treatment with or without antibiotic 7) The relationship between longitudinal changes of blood test (RBC, WBC, the subsets, PLT, Hb, BUN, Crea, TP, Alb, CK, AST, ALT, CRP) and the treatment with or without antibiotic 8) The relationship between longitudinal changes of blood test (RBC, WBC, the subsets, PLT, Hb, BUN, Crea, TP, Alb, CK, AST, ALT, CRP) and disease type, muscle biopsy performed region, operative duration of muscle biopsy and the value of manual muscle testing 9) The relationship between operative duration of muscle biopsy and disease type, muscle biopsy performed region, the value of manual muscle testing