Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India
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|ClinicalTrials.gov Identifier: NCT01691599|
Recruitment Status : Completed
First Posted : September 25, 2012
Last Update Posted : July 22, 2021
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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?
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||800 participants|
|Official Title:||Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Patients with open and closed tibia fracture treated with internal fixation in India
- Occurrence of infection [ Time Frame: From surgery until the date of first documented infection assessed up to 1 year ]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 ]
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|Ages Eligible for Study:||18 Years to 120 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Men and women who are 18 years of age or older.
- Open or closed tibia fracture treated by internal fixation (plate or nail), or by external fixation with planned conversion to plate or nail.
- Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.
- Written informed consent. Subjects with bilateral fractures will be included. In these subjects, the most severe fracture will be the one included in the study.
- Previous wound infection or osteomyelitis at the same limb (according to subject history).
- Subjects who plan to undergo conversion surgery at a different hospital.
- Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
- Immunological deficiency disease.
- Tumor related fractures.
- Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).
- Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
- Subject is a prisoner.
- Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691599
|Hi Tech Hospital|
|Gandhinagar, Gujarat, India, 382006|
|Dr. B.R. Ambedkar Medical College Hospital|
|Bangalore, Karnataka, India, 560 045|
|MOSC Medical College|
|Kochi, 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|
|Responsible Party:||AO Clinical Investigation and Publishing Documentation|
|Other Study ID Numbers:||
|First Posted:||September 25, 2012 Key Record Dates|
|Last Update Posted:||July 22, 2021|
|Last Verified:||June 2015|
Open tibia fractures
Closed tibia fractures
Wounds and Injuries