Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India
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:
- What is the infection rate within one year of surgery for open and closed tibia fracture subjects in India treated with internal fixation?
- 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?
- How are infections managed in open and closed tibia fracture subjects in India treated with internal fixation?
- What is the treatment outcome for open and closed tibia fracture subjects in India treated with internal fixation?
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?
- Hospital standard hygienic and antibiotic protocol for infection prevention
- Subject demographics
- Time between injury and surgery and between admission and surgery
- Fracture type (AO Müller classification)
- Soft tissue damage (according to the Tscherne classification for closed fractures or Gustilo classification for open fractures)
- Fracture management and implant type
- Surgical details such as duration of surgery
- 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?
- 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?
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.|
- Occurrence of infection [ Time Frame: From surgery until the date of first documented infection assessed up to 1 year ] [ Designated as safety issue: No ]LAB (CRP + ESR level, Leukocyte count / diff.) and bacteriology of wound swabs / aspirated liquids and sensitivity testing, if the patient is suspected for a surgical site infection (SSI)
- Change in Quality of life measurement (EQ-5D) [ Time Frame: Baseline and up to 5 day postoperative and 3months and 6months and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
Patients with open and closed tibia fracture treated with internal fixation in India
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691599
|Hi Tech Hospital|
|Gandhinagar, Gujarat, India, 382006|
|Dr. B.R. Ambedkar Medical College Hospital|
|Bangalore, Karnataka, India, 560 045|
|MOSC Medical College|
|Ernakulam District, Kerala, India, 625 007|
|Kolhapur Institute of Orthopedics and Trauma|
|Kolhapur, Maharashtra, India, 416 001|
|Dr. Balabhai Nanavati Hospital|
|Mumbai, Maharashtra, India, 400 056|
|Dr. R. N. Cooper Hospital|
|Mumbai, Maharashtra, India, 400 056|
|Jai Hospital Pvt. Ltd.|
|Nashik, Maharashtra, India, 422 002|
|Pune, Maharashtra, India, 411005|
|Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan|
|Sangli, Maharashtra, India, 416 416|
|Post Graduate Institute of Medical Education and Research|
|Chandigarh, Punjab, India, 160 012|
|Mukhopadhaya Orthopaedic Clinic and Research Centre|
|Bihar, India, 800 004|
|Principal Investigator:||Prakash J Doshi, MD||Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India|