CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 260 enrolled
Drug / intervention
Blood drawsother
Likely dose
Not stated in record
Key inclusion· 2
  • Prior fracture fixation with implant (intramedullary nail, plate, or screws), joint revision, periprosthetic fracture, or known orthopaedic infection
  • English-speaking
Key exclusion· 2
  • Planned follow-up at another medical center
  • Lives outside hospital catchment area

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03132246
NCT03132246N/ACompleted

Early Determination of Biofilm Formation on Orthopaedic Devices

University of Maryland, Baltimore·observational·Posted Apr 27, 2017·Updated May 15, 2020

In Brief

An observational study evaluating Blood draws for Open Reduction and Internal Fixation of Extremity Fractures. Completed, enrolled 260 participants across 1 site.

Detailed Summary

A prospective trial conducted at Shock Trauma of patients between 18 years of age and older who have sustained a fracture with metal implanted. The investigators will be collecting between 1-3 routine blood draws for the purpose of laboratory analysis to assess biofilm growth. Patients may be infected or non-infected at the time of blood draw; they will be selected at random for purposes of this study. All patients will be followed as standard of care by their treating physician for all their follow up visits.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedApr 27, 2017
Enrollment StartApr 1, 2014
Primary CompletionJun 30, 2018
Study CompletionJul 31, 2018
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.2 years ago

Interventions

Blood drawsother

The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.