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

Tibia Fracture Clinical Trial

Official title:

Infection Rates Following Internal Fixation of Open and Closed Tibia Fractures in India (INFINITI): a Prospective Multi-center Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01691599
• Other study ID #: INFINITI
• Status: Completed
• Start date: August 2012
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: AO Innovation Translation Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fractures, Bone
• Infection
• Tibia Fracture
• Tibial Fractures

Locations

Country	Name	City	State
India	Dr. B.R. Ambedkar Medical College Hospital	Bangalore	Karnataka
India	Mukhopadhaya Orthopaedic Clinic and Research Centre	Bihar
India	Post Graduate Institute of Medical Education and Research	Chandigarh	Punjab
India	Hi Tech Hospital	Gandhinagar	Gujarat
India	MOSC Medical College	Kochi	Kerala
India	Kolhapur Institute of Orthopedics and Trauma	Kolhapur	Maharashtra
India	Dr. Balabhai Nanavati Hospital	Mumbai	Maharashtra
India	Dr. R. N. Cooper Hospital	Mumbai	Maharashtra
India	Jai Hospital Pvt. Ltd.	Nashik	Maharashtra
India	Sancheti Hospital	Pune	Maharashtra
India	Orthopedic Hospital and Post Graduate Institute of Swasthiyog Pratishthan	Sangli	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
AO Clinical Investigation and Publishing Documentation

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of infection	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)	From surgery until the date of first documented infection assessed up to 1 year
Secondary	Change in Quality of life measurement (EQ-5D)		Baseline and up to 5 day postoperative and 3months and 6months and 12 months