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

Clean Laceration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899781
• Other study ID #: EMC-003812-CTIL
• Status: Completed
• Phase: Phase 4
• Start date: August 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2020
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hand laceration

• Tendon involeved

• Clean laceration

• No bone involved

Exclusion Criteria:

• Pregnant

• Children

• Immunocompremised patients

• "Dirty" lacerations

Related Conditions & MeSH terms

• Clean Laceration
• Hand Laceration
• Lacerations
• No Bone Involved
• Tendon Involved

Intervention

Drug:
• Antibiotic-Cefamezin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of wound infections	signs of wound/tissue infection, levels of WBC, ESR, CRP	2 years