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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02077400
Other study ID # 0115-09-EMC
Secondary ID
Status Completed
Phase N/A
First received March 2, 2014
Last updated July 9, 2015
Start date January 2006
Est. completion date February 2015

Study information

Verified date July 2015
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority Israel: HaEmek medical center, helsinki board
Study type Interventional

Clinical Trial Summary

Fingertip amputation is a common injury. Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury. The investigators goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment. The study hypothesis was that infection rates were similar in the two groups.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- fingertip amputation with bone exposed

Exclusion Criteria:

- under the age of 18 years

- if the patient had diabetes

- oncological disorder

- immune deficiency

- bleeding disorder

- used steroids regularly

- presented with a grossly contaminated wound or other injury requiring antibiotic treatment

- were currently taking antibiotics, or had a previous allergic reaction to cephalosporins.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Infection Rate After Fingertip Amputation

Intervention

Drug:
Cephazolin
Cephazolin

Locations

Country Name City State
Israel HaEmek medical center Afula

Sponsors (1)

Lead Sponsor Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary infection rate 1 month No