Skip to content

Optimum duration of antibiotics after surgery for bone infection

Conventional Versus Short Course Post-operative Antibiotic Therapy in Chronic Osteomyelitis ââ?¬â?? A Prospective Randomised Single Blinded Non-inferiority Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031537
Enrollment
78
Registered
2021-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M864- Chronic osteomyelitis with draining sinus

Interventions

Intervention1: One week post-operative antibiotic group: Drug - as per culture sensitivity. Route - intravenous. Dose and Frequency - depending on the drug used as per sensitivity. Duration - 1 week.

Sponsors

Sri Sathya Sai Institute of Higher Medical Sciences Prasanthigram
Lead Sponsor

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

MeasureTime frame
Comparison of recurrence rate in either groupTimepoint: 6 weeks, 3 months, 6 months, 1 year

Secondary

MeasureTime 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

Public ContactKoushik Narayan Subramanyam

Sri Sathya Sai Institute of Higher Medical Sciences - Prasanthigram, Puttaparthi.

drkoushik@hotmail.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026