Clinical trial NCT01691599: Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India
Official title: Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tibia Fracture
Keywords: Infection
Open tibia fractures
Closed tibia fractures
Wound infection
Lead sponsor: AO Innovation Translation Center
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with open or closed tibia fractures

Brief summary: 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?


Eligibility 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.

Primary outcomes:
measure: Occurrence of infection
timeFrame: From surgery until the date of first documented infection assessed up to 1 year
Secondary outcomes:
measure: Change in Quality of life measurement (EQ-5D)
timeFrame: Baseline and up to 5 day postoperative and 3months and 6months and 12 months
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: Hi Tech Hospital
state: Gujarat
city: Bangalore
country: India
facility: Dr. B.R. Ambedkar Medical College Hospital
state: Karnataka
city: Kochi
country: India
facility: MOSC Medical College
state: Kerala
city: Kolhapur
country: India
facility: Kolhapur Institute of Orthopedics and Trauma
state: Maharashtra
city: Mumbai
country: India
facility: Dr. Balabhai Nanavati Hospital
state: Maharashtra
city: Mumbai
country: India
facility: Dr. R. N. Cooper Hospital
state: Maharashtra
city: Nashik
country: India
facility: Jai Hospital Pvt. Ltd.
state: Maharashtra
city: Pune
country: India
facility: Sancheti Hospital
state: Maharashtra
city: Sangli
country: India
facility: Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan
state: Maharashtra
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
state: Punjab
city: Bihar
country: India
facility: Mukhopadhaya Orthopaedic Clinic and Research Centre
Study officials:
affiliation: Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India
name: Prakash J Doshi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doshi P, Gopalan H, Sprague S, Pradhan C, Kulkarni S, Bhandari M. Incidence of infection following internal fixation of open and closed tibia fractures in India (INFINITI): a multi-centre observational cohort study. BMC Musculoskelet Disord. 2017 Apr 14;18(1):156. doi: 10.1186/s12891-017-1506-4.