Modelling Interface Pressure Applied by Superimposed Compression Bandages
NCT ID: NCT02803398
Last Updated: 2016-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2016-02-29
Brief Summary
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Detailed Description
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Pressure measurements, applied by the different bandages, will be taken at the height of measurement points B1 and C on the lateral and medial sides of the leg in supine, sitting and standing positions, on both legs.
2 single bandages (Biflex 16 (Thuasne) and Rosidal K (Lohmann \& Rauscher)) and their different combinations will be applied on the patient's legs.
The order of bandage application for each patient is randomized, but is the same for both legs. The order of the leg (right or left) on which the bandages are applied is randomized.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Patient at risk of venous thrombosis
Compression bandages application and interface pressure measurements
Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher).
Interventions
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Compression bandages application and interface pressure measurements
Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher).
Eligibility Criteria
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Inclusion Criteria
* at risk of venous thrombosis, who need to wear compression (socks, stockings or bandage)
* Hospitalized in the Service of Physical Medicine and Rehabilitation, in Saint-Etienne, France
* BMI between 20 and 35
* Able to stand for at least 10 minutes in a standing frame
* Signed informed consent to take part in the study
* Covered by a health insurance system
* Not taking part in another study which interfere with the results of the present study
Exclusion Criteria
* Allergy to one of the different bandages components
* History of deep or superficial vein thrombosis
* Venous or arterial ulcer
* Cutaneous wound on the lower leg
* Cognitive, behavior or physical disorder preventing the communication and the active participation to a rehabilitation program, or a clinical study
* Patient under any legal protection (except curatorship)
* Not covered by a health insurance system
18 Years
80 Years
ALL
No
Sponsors
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Thuasne
INDUSTRY
Responsible Party
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Principal Investigators
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Pascal Giraux, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Service de Médecine Physique et de Réadaptation, CHU Saint-Etienne, France
Locations
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Service de Médecine Physique et de Réadaptation, CHU Bellevue
Saint-Etienne, , France
Countries
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References
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Chassagne F, Helouin-Desenne C, Molimard J, Convert R, Badel P, Giraux P. Superimposition of elastic and nonelastic compression bandages. J Vasc Surg Venous Lymphat Disord. 2017 Nov;5(6):851-858. doi: 10.1016/j.jvsv.2017.07.006.
Other Identifiers
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2015-A01219-40
Identifier Type: -
Identifier Source: org_study_id