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

NCT ID: NCT01899781

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-11-30

Brief Summary

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The investigators assume that simple hand lacerations involving flexors or extensors tendons, do not require prophylactic antibiotic treatment to prevent wound infection.

Detailed Description

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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.

Conditions

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Hand Laceration Tendon Involved Clean Laceration No Bone Involved

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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with antibiotic and without antibiotic

Group Type EXPERIMENTAL

Antibiotic-Cefamezin

Intervention Type DRUG

Interventions

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Antibiotic-Cefamezin

Intervention Type DRUG

Other Intervention Names

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Ceforal Keflex

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant
* Children
* Immunocompremised patients
* "Dirty" lacerations
Minimum Eligible Age

13 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EMC-003812-CTIL

Identifier Type: -

Identifier Source: org_study_id

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