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Use of antibiotic beads to prevent infection after facial fracture surgery

Efficacy of Local Antibiotic Beads versus Standard Care in Preventing Implant-Site Infection in Craniomaxillofacial Trauma Surgery: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/108706
Enrollment
122
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: - Health Condition 2: V20-V29- Motorcycle rider injured in transport accident

Interventions

Intervention1: Antibiotic beads: Open reduction and internal fixation will be performed using standard surgical techniques. Preoperative systemic antibiotic prophylaxis will be administered as intrave

Sponsors

AIIMS Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: CMF fractures requiring ORIF Surgery within 14 days Clean/clean-contaminated wound Consent + follow-up willingness

Exclusion criteria

Exclusion criteria: Active infection at fracture site Pathological fractures Previous hardware same site Immunocompromised / systemic disease Antibiotic allergy Pregnancy Refusal of consent

Design outcomes

Primary

MeasureTime frame
Proportion of implant-site infectionTimepoint: Day 7, Day 30, and Day 90 post-operatively, and at any unscheduled visit if symptoms of infection occur up to 90 days

Secondary

MeasureTime frame
Time to infectionTimepoint: Up to 90 days post-operatively;Proportion of patients requiring debridement, implant removal, or revision surgery due to infectionTimepoint: Within 90 days post-operatively;Patient-reported pain scores using Visual Analog Scale (VAS 0 10)Timepoint: Day 7, Day 30, and Day 90 post-operatively;Functional recovery assessed by occlusion and mouth openingTimepoint: Day 30 and Day 90 post-operatively;Incidence of adverse events related to antibiotic beads (e.g., wound complications, allergic reactions)Timepoint: Up to 90 days post-operatively

Countries

India

Contacts

Public ContactVyakhya Akhileshkumar Gupta

AIIMS patna

vyakhya31@gmail.com07984272225

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026