Trial document





This trial has been registered retrospectively.
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  DRKS00000468

Trial Description

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Title

Routine pin tract care in external fixation

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Assesment of Pin site care after fixation of a fracture with a external fixation system.
Is there a difference between daily pin site care and no care at all.
On the same patient, half of the pins are treated with daily care, half of them not.

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Brief Summary in Scientific Language

Method: Consecutive patients series recruited in the National Referral Hospital in Honiara in the Solomon Islands.
Pin treatment was allocated into groups anatomically, proximal and distal.
Randomisation was intra-subject and intra-group: Rx0 pins had daily pin site care and Rx1 had no treatment at all.
Endpoints: soft-tissue interface, stability of the pins, torsional stability as determined with a torque meter, osteolysis and pain. Assessment of pin sites blinded. Statistical analisys using the paired t test for parametric data and the Wilcoxon rank test for non-parametric data (Stat View)

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Organizational Data

  •   DRKS00000468
  •   2010/07/16
  •   [---]*
  •   yes
  •   Approved
  •   [---]*, Health Comission National Referral Hospital Honiara Honiara, Solomon Islands
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Secondary IDs

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Health Condition or Problem studied

  •   infection postoperative
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Interventions/Observational Groups

  •   daily pin site care with - removal of crusts, cleaning of pins, desinfection with betadine, new dressing
  •   no pin site care at all
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Double or multiple blind
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  •   No treatment
  •   Prevention
  •   Parallel
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  •   [---]*
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Primary Outcome

assesment of soft-tissue interface, stability of the pins, torsional stability as determined with a torque meter, osteolysis and pain

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Secondary Outcome

[---]*

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Countries of Recruitment

  •   Solomon Islands
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2000/01/04
  •   56
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   6   Years
  •   56   Years
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Additional Inclusion Criteria

External fixateur fixation in our clinic

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Exclusion Criteria

Exclusion criteria were application of ExFix for less than two weeks or a non-standard ExFix.

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Addresses

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    • Universitäts Kinderspital beider Basel
    • Mr.  Dr.   Carlo  Camathias 
    • Postfach
    • 4005  Basel
    • Switzerland
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    • Universitäts Kinderspital beider Basel UKBB
    • Mr.  Dr.  Carlo  Camathias 
    • Postfach
    • 4005  Basel
    • Switzerland
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  • start of 1:1-Block address public-contact
    • Universitäts Kinderspital Beider Basel UKBB
    • Mr.  Dr.   Carlo  Camathias 
    • Postfach
    • 4005  Basel
    • Switzerland
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Sources of Monetary or Material Support

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    • Universitäts Kinderspital beider Basel
    • Mr.  Dr.  Carlo  Camathias 
    • Postfach
    • 4005  Basel
    • Switzerland
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Status

  •   Recruiting complete, follow-up complete
  •   2002/01/22
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Trial Publications, Results and other Documents

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  •   No reference yet.
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* This entry means the parameter is not applicable or has not been set.