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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT01691599
First received: September 17, 2012
Last updated: March 18, 2014
Last verified: September 2012
  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:


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), or by external fixation with planned conversion to 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. Previous wound infection or osteomyelitis at the same limb (according to subject history).
  2. Subjects who plan to undergo conversion surgery at a different hospital.
  3. Previous fracture with retained hardware in injured extremity that will interfere with implant fixation.
  4. Immunological deficiency disease.
  5. Tumor related fractures.
  6. Any severe systemic disease: class V-VI of the American Society of Anesthesiologists (ASA) physical status classification (Appendix 5).
  7. Recent history of substance abuse (i.e. recreational drugs, alcohol) that would preclude reliable assessment.
  8. Subject is a prisoner.
  9. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691599

Locations
India
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
Sancheti Hospital
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
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: March 18, 2014
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
Infection
Communicable Diseases
Tibial Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on September 22, 2014