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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified July 2013 by HaEmek Medical Center, Israel.
Recruitment status was: Not yet recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT01899781

First Posted: July 15, 2013

Last Update Posted: July 15, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

HaEmek Medical Center, Israel

Purpose

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

Condition	Intervention	Phase
Hand Laceration Tendon Involved Clean Laceration No Bone Involved	Drug: Antibiotic-Cefamezin	Phase 4


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Tears

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

rate of wound infections [ Time Frame: 2 years ]
signs of wound/tissue infection, levels of WBC, ESR, CRP


Estimated Enrollment:	60
Study Start Date:	August 2013
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: with antibiotic and without antibiotic	Drug: Antibiotic-Cefamezin Other Names: Ceforal Keflex

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.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	13 Years to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Hand laceration
Tendon involeved
Clean laceration
No bone involved

Exclusion Criteria:

Pregnant
Children
Immunocompremised patients
"Dirty" lacerations

Contacts and Locations

No Contacts or Locations Provided

More Information


Responsible Party:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT01899781 History of Changes
Other Study ID Numbers:	EMC-003812-CTIL
First Submitted:	July 11, 2013
First Posted:	July 15, 2013
Last Update Posted:	July 15, 2013
Last Verified:	July 2013

Keywords provided by HaEmek Medical Center, Israel:


Lacerations Tendons Antobiotic

Additional relevant MeSH terms:


Lacerations Wounds and Injuries Anti-Bacterial Agents	Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents

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