Antibiotic loaded ceramic nanobeads for bone infection

Phase 1

Completed

• Conditions: Osteomyelitis and infected fractures and non-unions

• Registration Number: CTRI/2012/12/003179
• Lead Sponsor: Shri Chitra Tirunal Institute of Medical Sciences

Brief Summary

Chronic osteomyelitisis treated by surgical debridement and antibiotics. Historically bone cementbeads loaded with antibiotics were used in treatment as they allowed a highlocal concentration of antibiotics with minimal systemic levels. Thedisadvantages were the need for a second surgery to remove the cement beads andsince the bone cement sets by an exothermic process releasing heat, only heatstable antiobiotics could be used. We propose to use ceramic (hydroxyapatite)nanobeads developed by the Sri Chitra Thirunal Institute in chronicosteomyelitis in children. The theoretical advantages are the fact that anyantibiotic can be added as no heat is released, the nanobeads are biodegradableand so no second surgery is needed. Moreover these beads can be used to fillbone defects when they co-exist. These beads have been used anecdotally before.We propose to do a pilot study to check the safety and feasibility of thesebeads in chronic osteomyelitis in children so as to plan a future clinicaltrial on the same.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-09
• Last Update Posted: 2015-04-07

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Children with pyogenic bone infections and infected non-unions.

Exclusion Criteria

Children who cannot be followed up for one year on a regular basis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse effect such as – Allergic reactions	Major adverse effect such as – Allergic reactions

Secondary Outcome Measures

Name	Time	Method
Eradication of infection and improvement in bone healing

Trial Locations

Locations (1)

Paediatric orthopaedic unit; 🇮🇳 Vellore, TAMIL NADU, India

Paediatric orthopaedic unit

🇮🇳Vellore, TAMIL NADU, India

DR VRISHA MADHURI

Principal investigator

madhuriwalter@cmcvellore.ac.in