A randomized controlled trial assessing the effectiveness of additional local gentamicin injection on reduction of infection rates in patients with open tibial fracture
Not Applicable
Recruiting
- Conditions
- open tibial fracture
- Registration Number
- TCTR20170625002
- Lead Sponsor
- Hatyai hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 142
Inclusion Criteria
Patients with open tibial fracture type II and type IIIA, according to Gustilo-Anderson classification.
Exclusion Criteria
-Patients who have preexisting infection at the operative site.
-Patients who are known to have major systemic infection at the time of injury.
-Patients who have pathologic open fracture.
-Patients who have a history of gentamicin allergy or a contraindication to gentamicin use, or eGFR<60 ml/min/1.73 m^2.
-Patients who have moderate or severe head injury. (Glasgow coma score less than 13).
-Patients who are uncooperative.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Infection and nonunion rates 6 years percents of Infection and nonunion rates
- Secondary Outcome Measures
Name Time Method gentamicin concentration from the wound 6 years mcg/ml