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Towards the right antibiotic for infection in external fixation

Formulation and Prospective Comparitive Evaluation of Two Empirical Antibiotic Protocols in Pin Site Infections in Ilizarov - Retroprospective Randomised Double Blind Superiority Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031382
Enrollment
70
Registered
2021-02-17
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: L088- Other specified local infections of the skin and subcutaneous tissue

Interventions

Intervention1: Cotrimoxazole group: Empirical treatment of pin site infection with Co-trimoxazole (800/160 mg) orally twice daily for7 days Control Intervention1: Clindamycin group: Empirical treatmen

Sponsors

Sri Sathya Sai Institute of Higher Medical Sciences Prasanthigram Puttaparthi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Ilizarov fixator applied for any indication other than bone infection or open fractures

Exclusion criteria

Exclusion criteria: 1. Past history of osteomyelitis 2. Soft tissue infection in the segment where Ilizarov fixator is applied 3. Not willing for pin site follow-up protocol

Design outcomes

Primary

MeasureTime frame
Comparison of success rate of cure of infection in either groupsTimepoint: At weekly intervals till removal of fixator

Secondary

MeasureTime frame
1. Comparison of mean duration of infection� 2. Comparison of incidence of deep infection and complications 3. Correlation of microbiological sensitivity versus clinical response in both groups 4. Compare incidence of drug specific adverse events between both groups 5. Risk factor analysis for the cases that did not respond to either empirical antibiotic protocol. Timepoint: At weekly intervals till removal of fixator

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