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

This study is not yet open for participant recruitment. (see Contacts and Locations)

Verified July 2013 by HaEmek Medical Center, Israel

Sponsor:

Information provided by (Responsible Party):

HaEmek Medical Center, Israel

ClinicalTrials.gov Identifier:

NCT01899781

First received: July 11, 2013

Last updated: July 12, 2013

Last verified: July 2013

History of Changes

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:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 ] [ Designated as safety issue: No ]
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


Ages Eligible for Study:	13 Years to 75 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT01899781 History of Changes
Other Study ID Numbers:	EMC-003812-CTIL
Study First Received:	July 11, 2013
Last Updated:	July 12, 2013
Health Authority:	Israel: Ethics Commission

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 Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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