NCT01691599

Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India

Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 800 (actual)
• Sponsor: AO Clinical Investigation and Publishing Documentation · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

The objectives of this study are to investigate infection rates and management for open and closed tibia fracture subjects in India treated with internal fixation. These objectives will be carried out by answering the following questions: 1. What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation? 2. What is the distribution of infection per type of infection, stratified by time (early, delayed, late) and location (superficial or deep) in open and closed tibia fracture subjects in India treated with internal fixation? Secondary objectives 1. How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation? 2. What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation? 3. What is the influence of the following clinic and subject factors on the occurrence of infection within one year for open and closed tibia fracture subjects in India treated with internal fixation? 1. Hospital standard hygienic and antibiotic protocol for infection prevention 2. Subject demographics 3. Time between injury and surgery and between admission and surgery 4. Fracture type (AO Müller classification) 5. Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures) 6. Fracture management and implant type 7. Surgical details such as duration of surgery 4. Is there a difference in health-related quality of life as measured by the EuroQol-5 Dimensions (EQ-5D) between subjects with and without infections? 5. Is there a difference in the number of complications not related to infection (adverse events and serious adverse events) between subjects with and without infections?

Conditions

• Tibia Fracture

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-09-25
• Last updated: 2021-07-22

Locations

11 sites across 1 country: India