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

This study is currently recruiting participants.
Verified September 2012 by AO Clinical Investigation and Documentation
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01691599
First received: September 17, 2012
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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?

Condition
Tibia Fracture

Study Type: Observational
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.

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
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)
Groups/Cohorts
Tibia fractures
Patients with open and closed tibia fracture treated with internal fixation in India

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with open or closed tibia fractures

Criteria

Inclusion Criteria:

  1. Men and women who are 18 years of age or older.
  2. Open or closed tibia fracture treated by internal fixation (plate or nail).
  3. Ability to understand the content of the subject information / informed consent form and to be willing to participate in the clinical investigation.
  4. 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:

  1. Subjects with fractures older than 14 days at the time of enrollment.
  2. Previous wound infection or osteomyelitis at the same limb (according to subject history).
  3. External fixation (before internal fixation or as main intervention).
  4. Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
  5. Immunological deficiency disease.
  6. Tumor related fractures.
  7. Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).
  8. Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
  9. Subject is a prisoner.
  10. Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691599

Contacts
Contact: Patrick Hiltpold, M.Sc +41 79 572 59 14 patrick.hiltpold@aofoundation.org

Locations
India
Hi Tech Hospital Recruiting
Gandhinagar, Gujarat, India, 382006
Contact: Mahipatsinh Parmar, MD     +91 9825686088     hitech.hospital2008@gmail.com    
Principal Investigator: Vijay H. Upadhyay, MD            
Dr. B.R. Ambedkar Medical College Hospital Not yet recruiting
Bangalore, Karnataka, India, 560 045
Contact: Pradeep Kumar Shetty, MD     +91 9886737956     pradeepkumarkshetty@gmail.com    
Principal Investigator: Rajeev Naik, Prof. MD            
MOSC Medical College Not yet recruiting
Ernakulam District, Kerala, India, 625 007
Contact: Hitesh Gopalan, MD     +91 9995397750     hiteshq@gmail.com    
Principal Investigator: Hitesh Gopalan, MD            
Kolhapur Institute of Orthopedics and Trauma Recruiting
Kolhapur, Maharashtra, India, 416 001
Contact: Suryakart Bharamganda, MD     +91 9822276412     dr.slb@rediffmail.com    
Principal Investigator: Kiran Doshi, MD            
Dr. Balabhai Nanavati Hospital Recruiting
Mumbai, Maharashtra, India, 400 056
Contact: Sachin Bhat, MD     +91 9821633236     drsachinbhat@gmail.com    
Principal Investigator: Prakash Doshi, MD            
Dr. R. N. Cooper Hospital Not yet recruiting
Mumbai, Maharashtra, India, 400 056
Contact: Sushant Ghate, MD     +91 9833055526     ssushantghate@gmail.com    
Principal Investigator: Sunil M. Shahane, MD            
Jai Hospital Pvt. Ltd. Not yet recruiting
Nashik, Maharashtra, India, 422 002
Contact: Yogesh Dhole, MD     +91 9970172872     dryogeshdhole@gmail.com    
Principal Investigator: Vijay Kakatkar, MD            
Sancheti Hospital Recruiting
Pune, Maharashtra, India, 411005
Contact: Archana Pansare     +91 8551053003     archanapansare17@gmail.com    
Principal Investigator: Chetan Pradhan, MD            
Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan Recruiting
Sangli, Maharashtra, India, 416 416
Contact: Sangita Kharade, MD     +91 9970534007     sangeeta_kharade@yahoo.co.in    
Principal Investigator: Sunil Kulkarni, MD            
Post Graduate Institute of Medical Education and Research Not yet recruiting
Chandigarh, Punjab, India, 160 012
Contact: Sarvdeep Dhatt, MD     +91 9815126600     sdhatt@yahoo.com    
Principal Investigator: Mandeep Dhillon, Prof. MD            
Mukhopadhaya Orthopaedic Clinic and Research Centre Recruiting
Bihar, India, 800 004
Contact: Swastik Shivapuri, MD     +91 9431078631     drswastik@gmail.com    
Principal Investigator: John Mukhopadhaya, MD            
Sponsors and Collaborators
AO Clinical Investigation and Documentation
Investigators
Principal Investigator: Prakash J Doshi, MD Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India
  More Information

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT01691599     History of Changes
Other Study ID Numbers: INFINITI
Study First Received: September 17, 2012
Last Updated: September 20, 2012
Health Authority: India: Health Ministry's Screening Committee (HMSC)

Keywords provided by AO Clinical Investigation and Documentation:
Infection
Open tibia fractures
Closed tibia fractures
Wound infection

Additional relevant MeSH terms:
Fractures, Bone
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 23, 2013