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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
Sponsor:
Collaborators:
Instituto de Ortopedia e Traumatologia de Passo Fundo
Universidade de Passo Fundo
Information provided by (Responsible Party):
Faculdade de Ciências Médicas da Santa Casa de São Paulo

Brief Summary:
The present study is a prospective non-randomized and comparative study of patients undergoing surgical treatment with external fixators of any type, between May 2018 and May 2020, in the city of Passo Fundo, RS, Brazil, in the São Vicente de Paulo hospitals. A study in which we compared infection rates, pin loosening and complications found in external fixators made with hydroxyapatite coated pins and uncoated steel pins.

Condition or disease
External Fixation Pin Site Infection

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 119 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who underwent surgical treatment with external fixators for at least 2 weeks, regardless of age, gender and comorbidities.
Criteria

Inclusion Criteria:

  • We will select for the study patients who agree to participate, signing the commitment term for data use, and who underwent surgical treatment with external fixation of any type both for fracture treatment and correction of deformities, treatment of osteomyelitis and or pseudoarthrosis , for a minimum period of 2 weeks.

Exclusion Criteria:

  • We will exclude patients who do not agree to participate in the study, patients who have had external fixation for less than 2 weeks, and patients in whom we have lost follow-up.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649425


Contacts
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Contact: Cristhopher L Stoffel 5554981249707 cristoffel@outlook.com
Contact: Mauro Salles 5511985360055 salles.infecto@gmail.com

Locations
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Brazil
Hospital São Vicente de Paulo Recruiting
Passo Fundo, Rio Grande Do Sul, Brazil, 99010-080
Contact: Ivânio Tagliari    5554991173026    ivanio.tagliari@gmail.com   
Contact: Cristhopher L Stoffel    5554981249707    cristoffel@outlook.com   
Sponsors and Collaborators
Faculdade de Ciências Médicas da Santa Casa de São Paulo
Instituto de Ortopedia e Traumatologia de Passo Fundo
Universidade de Passo Fundo

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Responsible Party: Faculdade de Ciências Médicas da Santa Casa de São Paulo
ClinicalTrials.gov Identifier: NCT03649425    
Other Study ID Numbers: 84939418.6.0000.5342
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Faculdade de Ciências Médicas da Santa Casa de São Paulo:
infection
pin site
external fixator
hydroxyapatite coated
Additional relevant MeSH terms:
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Infection