- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
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?
Secondary objectives
- 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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Bihar, India, 800 004
- Mukhopadhaya Orthopaedic Clinic and Research Centre
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Gujarat
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Gandhinagar, Gujarat, India, 382006
- Hi Tech Hospital
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Karnataka
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Bangalore, Karnataka, India, 560 045
- Dr. B.R. Ambedkar Medical College Hospital
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Kerala
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Kochi, Kerala, India, 625 007
- MOSC Medical College
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Maharashtra
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Kolhapur, Maharashtra, India, 416 001
- Kolhapur Institute of Orthopedics and Trauma
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Mumbai, Maharashtra, India, 400 056
- Dr. Balabhai Nanavati Hospital
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Mumbai, Maharashtra, India, 400 056
- Dr. R. N. Cooper Hospital
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Nashik, Maharashtra, India, 422 002
- Jai Hospital Pvt. Ltd.
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Pune, Maharashtra, India, 411005
- Sancheti Hospital
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Sangli, Maharashtra, India, 416 416
- Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan
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Punjab
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Chandigarh, Punjab, India, 160 012
- Post Graduate Institute of Medical Education and Research
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Tibia fractures
Patients with open and closed tibia fracture treated with internal fixation in India
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of infection
Time Frame: From surgery until the date of first documented infection assessed up to 1 year
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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)
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From surgery until the date of first documented infection assessed up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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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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Baseline and up to 5 day postoperative and 3months and 6months and 12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Prakash J Doshi, MD, Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- INFINITI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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