Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon

February 12, 2020 updated by: HaEmek Medical Center, Israel
The investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hand lacerations are divided to "complicated" which involves tendons, nerves, bones, and joints, and "simple" which involves only cutaneous and subcutaneous tissue.

prophylactic antibiotic should not be given in a clean simple lacerations, and should be given when a bone is involve (open fracture). But there is not enough data, weather prophylactic antibiotic treatment should be given when only tendons are involved. The investigators will examine 2 groups of 30 patients each with clean hand lacerations involving tendons. One group will be treated with prophylactic antibiotic and the other wont be treated, randomly. The investigators assume that the rate of wound infection wont be different between the 2 groups.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Hand laceration
  • Tendon involeved
  • Clean laceration
  • No bone involved

Exclusion Criteria:

  • Pregnant
  • Children
  • Immunocompremised patients
  • "Dirty" lacerations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: with antibiotic and without antibiotic
Drug: Antibiotic-Cefamezin
Other Names:
  • Keflex
  • Ceforal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of wound infections
Time Frame: 2 years
signs of wound/tissue infection, levels of WBC, ESR, CRP
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

July 11, 2013

First Submitted That Met QC Criteria

July 12, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMC-003812-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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