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Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.
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?
Age
18 - 120 years
Sex
ALL
Healthy Volunteers
No
Hi Tech Hospital
Gandhinagar, Gujarat, India
Dr. B.R. Ambedkar Medical College Hospital
Bangalore, Karnataka, India
MOSC Medical College
Kochi, Kerala, India
Kolhapur Institute of Orthopedics and Trauma
Kolhāpur, Maharashtra, India
Dr. Balabhai Nanavati Hospital
Mumbai, Maharashtra, India
Dr. R. N. Cooper Hospital
Mumbai, Maharashtra, India
Jai Hospital Pvt. Ltd.
Nashik, Maharashtra, India
Sancheti Hospital
Pune, Maharashtra, India
Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan
Sangli, Maharashtra, India
Post Graduate Institute of Medical Education and Research
Chandigarh, Punjab, India
Start Date
August 1, 2012
Primary Completion Date
June 1, 2015
Completion Date
June 1, 2015
Last Updated
July 22, 2021
800
ACTUAL participants
Lead Sponsor
AO Clinical Investigation and Publishing Documentation
NCT05668182
NCT07193524
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