Health Condition 1: M864- Chronic osteomyelitis with draining sinus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients presenting with symptoms of osteomyelitis of duration more than six months 2. Intraoperative isolation of an organism from bone culture that is susceptible to antibiotics (intravenous and oral) along with any one of the following (Diagnostic criteria) A. Evidence of local inflammatory response, manifested as local pain, edema, erythema, warmth, or drainage. B. Evidence of systemic inflammatory response, manifested as fever, elevated C---reactive protein (CRP) level, or white blood cell count. C. Osteomyelitis-compatible findings on plain radiograph, computed tomography or magnetic resonance imaging (if indicated for surgical planning)
Exclusion criteria
Exclusion criteria: 1. Children and adolescents 2. Recurrent chronic osteomyelitis (history of previous treatment) 3. Not willing follow up as per study protocol 4. Pregnancy 5. History of intake of steriods or immunosuppressive medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of recurrence rate in either groupTimepoint: 6 weeks, 3 months, 6 months, 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of antibiotic related adverse events 2. Comparison of cost of treatment in either groups 3. Risk factor analysis for recurrence in both groups 4. Correlation of preoperative, intraoperative and recurrence isolates Timepoint: Any time within 1 year from surgical debridement | — |
Countries
India
Contacts
Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram, Puttaparthi.