A multicenter study of localized antibiotic released hydroxyapatite beads for bone infection treatment in Thailand
- Conditions
- The ability of new antibiotics impregnated hydroxyapatite beads in treatment of chronic osteomyelitis will be evaluated together with the bone fusion properties.Antibiotics beadsOsteomyelitisHydroxyapatite
- Registration Number
- TCTR20170123002
- Lead Sponsor
- Health System Research Institute
- Brief Summary
Satisfactory outcomes were observed in term of success rate, quality of life and adverse effect. Systemic exposure to vancomycin and gentamicin after beads implantation was limited and high local antibiotics concentrations were found in wound drainage fluid at 24, 48 and 72 h. Blood chemistry measurements did not show any nephrotoxic or hepatotoxic effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 53
Patients who are diagnosed as chronic osteomyelitis by having bone infection for more than 6 weeks, having dead bone and bone reparative reaction.
-Cierny & Mader anatomical staging class A and B.
-Patients who are allergy to vancomycin, gentamicin and fosfomycin antibiotics
-Patient who need ongoing antibiotics treatment i.e melioidosis.
-Patients who have renal insufficiency or renal failure (eGFR < 30 ml/min/m2 by Cockcroft-Gault equation (CG))
-HIV patients and/or CD4 < 350 cell/ mm3
-Patients who are pregnant and lactation
-DM patients or having HbA1C > 8% at 3 months prior to enrollment.
-Patients
-Patients who have multiple active injuries or head injuries
-Immunocompromided patient or having history of using immunosuppressive drug or corticosteroid equivalent to Prednisolone > 10 mg per day for longer than 2 wks
-Patients having history of using folk medicine containing steroids
-Patients who have malignancy at site of infection
-Patients who use or having history of using narcotic drugs or using syringe with others.
-Patient who were infected with antibiotic-resistant gram-negative bacteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of antibiotics impregnated hydroxyapatite beads 12 wks Clinical evaluation, Blood chemistry, X-ray,Reinfection rate of antibiotics impregnated hydroxyapatite beads 24 wks Clinical evaluation, Blood chemistry, X-ray
- Secondary Outcome Measures
Name Time Method Quality of life Immediate Postop, 6 wks, 12 wks, 24 wks Questionaire,Time to discharge 2 wks, 4 wks, 6 wks Chart review