NCT02803398

Modelling Interface Pressure Applied by Superimposed Compression Bandages

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to measure and model interface pressure applied on the lower leg of patients at risk of veinous thrombosis, by different bandage combinations, composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann \& Rauscher). The patient specific model should better predict the interface pressure distribution than Laplace's Law.

Detailed description

The measurement of the patients' legs shapes will be performed thanks to an optical scanner. The patients' posterior part of the calf will be submitted to a localized compression test, in order to characterize the soft tissue mechanical properties of both legs. 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

• Risk of Venous Thrombosis

Interventions

Type	Name	Description
OTHER	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).

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-12-01
• First posted: 2016-06-17
• Last updated: 2016-12-29

Locations

1 site across 1 country: France