COMPARATIVE PROSPECTIVE STUDY OF COMPLICATIONS FOUND IN THE PINS OF EXTERNAL FIXERS COMPARING STEEL PINS AND PINS COATED WITH HYDROXIAPATITA
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|ClinicalTrials.gov Identifier: NCT03649425|
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 28, 2018
|Condition or disease|
|External Fixation Pin Site Infection|
We will use as a guide to define the degree of infection and the conduct to be taken in the classification of Mas Oxford Nuffield (Table 3), therefore the presence of infection occurring in patients classified as Grade 2 - erythema of the skin, serous or purulent secretion, pain and sensitivity in soft tissues capable of mobilizing with analgesia. We will also send to the culture the tip of two pins removed from each patient to evaluate possible colonization and to compare with the degree of classification presented in the pin in question, we will do this with a pin without signal of infection and with the pin with the highest degree of classification presented in each patient at the time of the external fixator removal.
We will use as a method of insertion of the pin the pre-perforation irrigated before the insertion of the pins, to decrease the chances of thermal necrosis and consequent release or infection. We will use steel Shanz pins coated with hydroxyapatite or not in size between 5-6mm. Comorbidities and risk factors such as diabetes mellitus, smoking, immunodepression, among others, will be computed for later comparison with the data collected. The degree of classification of the fractures, as well as the pathologies that were treated with the fixators, as well as the residence time with the external fixator will also be computed for later comparison with the data collected.
For the elaboration of this study, the patients will be prospectively observed, which will be submitted to the treatment of several pathologies with external fixators, of any type. The occurrence of infection and / or loosening of the pins, as well as the influence of risk factors and the cultural examination results of the pins removed at the end of the treatment will be recorded. The objectives of the study are to comparatively evaluate the differences in complications of infection, pin loosening and microbiological results of cultural examinations, between patients submitted to external fixators with uncoated steel pins and steel pins coated with hydroxyapatite. The influence of risk factors on outcomes will also be observed.
|Study Type :||Observational|
|Estimated Enrollment :||119 participants|
|Official Title:||COMPARATIVE PROSPECTIVE STUDY OF SURFACE AND DEEP COMPLICATIONS FOUND IN THE PINS OF EXTERNAL FIXERS COMPARING STEEL PINS AND PINS COATED WITH HYDROXIAPATITA|
|Actual Study Start Date :||May 14, 2018|
|Estimated Primary Completion Date :||November 25, 2019|
|Estimated Study Completion Date :||May 15, 2020|
hydroxyapatite coated pins
Patients submitted to surgical treatment with external fixators using pins coated with hydroxyapatite.
uncoated steel pins
Patients submitted to surgical treatment with external fixators using uncoated steel pins.
- compare infectious complications [ Time Frame: April 2018 and December 2019 ]To compare superficial and deep infectious complications associated with the presence of external fixation pins. To evaluate the incidence and degree of infection at pin insertion sites, osteomyelitis and wound infection, comparatively between hydroxyapatite and uncoated pins.
- Evaluate the incidence of loosening of the pins [ Time Frame: April 2018 and December 2019 ]To evaluate the incidence of pin loosening, comparatively between pins coated with hydroxyapatite and uncoated pins, in the external fixators.
- risk factors and comorbities associated [ Time Frame: April 2018 and December 2019 ]To evaluate the risk factors and comorbidities associated with infectious complications and pin loosening in the patients participating in the study
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649425
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