Prophylactic Antibiotic Treatment for Hand Lacerations Involving Flexor and/or Extensor Tendon
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2013 by HaEmek Medical Center, Israel.
Recruitment status was Not yet recruiting
Recruitment status was Not yet recruiting
Sponsor:
HaEmek Medical Center, Israel
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
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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:
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:
|
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 (Child, Adult, Senior) |
| 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
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More Information
| 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 |
ClinicalTrials.gov processed this record on September 27, 2016