Infection Rates Following Internal Fixation of Open and C... | NCT01691599

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

NCT01691599

Sponsor

AO Clinical Investigation and Publishing Documentation

Status

Completed

Last Update Posted

Jul 22, 2021Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Tibia Fracture

Interventions

Not provided

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Sep 17, 2012

First Submission Date that Met QC Criteria

Sep 20, 2012

First Posted Date

Sep 25, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 21, 2021

Last Update Posted Date

Jul 22, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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?
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
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?

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Label	Type	Description	Intervention Names
Tibia fractures		Patients with open and closed tibia fracture treated with internal fixation in India

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
Change in Quality of life measurement (EQ-5D)		Baseline and up to 5 day postoperative and 3months and 6months and 12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with open or closed tibia fractures

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prakash J Doshi, MD	Chief of Orthopaedics and Traumatology, Dr. Balabhai Nanavati Hospital, India	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hi Tech Hospital		Gandhinagar	Gujarat	382006	India
Dr. B.R. Ambedkar Medical College Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28410572	Derived	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.

ID	Term
D013978	Tibial Fractures
D007239	Infections
D014946	Wound Infection

ID	Term
D050723	Fractures, Bone
D014947	Wounds and Injuries
D007869	Leg Injuries