NCT02077400

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
8.2 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 10, 2015

Status Verified

July 1, 2015

Enrollment Period

9.1 years

First QC Date

March 2, 2014

Last Update Submit

July 9, 2015

Conditions

Infection Rate After Fingertip Amputation

Outcome Measures

Primary Outcomes (1)

  • infection rate

    1 month

Study Arms (2)

no antibiotic

NO INTERVENTION

Cephazolin

ACTIVE COMPARATOR

cefazoline

Drug: Cephazolin

Interventions

CephazolinDRUG

Cephazolin

Also known as: Cefamezine
Cephazolin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • fingertip amputation with bone exposed

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HaEmek medical center

Afula, 18101, Israel

Location

MeSH Terms

Interventions

Cefazolin

Intervention Hierarchy (Ancestors)

Cephalosporinsbeta-LactamsLactamsAmidesOrganic ChemicalsThiazinesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

March 2, 2014

First Posted

March 4, 2014

Study Start

January 1, 2006

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 10, 2015

Record last verified: 2015-07

Locations

IL(1)