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

Randomized clinical trial of antibiotic prophylaxis versus no intervention in muscle biopsy - pros and cons antibiotic prophylaxis in muscle biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000034535
Enrollment
24
Registered
2018-10-18
Start date
2018-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with planning muscle biopsy

Interventions

The group with single-dose antibiotic prophylaxis of cefazolin (1g) at muscle biopsy. The group without antibiotic prophylaxis at muscle biopsy

Sponsors

Kumamoto university
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Over 20 years old and less than 80 years old 2) Patient or proxy who can provide a informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The incidence and proportion of wound infection after muscle biopsy

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactKoutaro Takamatsu

Graduate School of Medical Sciences, Kumamoto University Department of Neurology

takamakt@gmail.com096-373-5893

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026