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Modelling Interface Pressure Applied by Superimposed Compression Bandages

Primary Purpose

Risk of Venous Thrombosis

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Compression bandages application and interface pressure measurements

About this trial

This is an interventional basic science trial for Risk of Venous Thrombosis focused on measuring Compression bandages

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female between 18 and 80 years old
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:

Compression bandages contraindications
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

Sites / Locations

Service de Médecine Physique et de Réadaptation, CHU Bellevue

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patient at risk of venous thrombosis

Arm Description

Outcomes

Primary Outcome Measures

Consistency between interface pressure [mmHg] given by the patient-specific simulation and the experimental pressure measurements for different positions (supine, sitting, standing) and the different bandage combinations.

Secondary Outcome Measures

Evaluation of the impact of soft tissue mechanical propreties on interface pressure

Patient's leg soft tissue mechanical properties are characterized for both patient's legs before bandage application. The impact of this parameter on the measured interface pressure will be evaluated.

Full Information

NCT ID

NCT02803398

First Posted

June 8, 2016

Last Updated

December 28, 2016

Sponsor

Thuasne

1. Study Identification

Unique Protocol Identification Number

NCT02803398

Brief Title

Modelling Interface Pressure Applied by Superimposed Compression Bandages

Official Title

Modelling Interface Pressure Applied by Superimposed Compression Bandages

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

February 2016 (undefined)

Primary Completion Date

December 2016 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thuasne

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Risk of Venous Thrombosis

Keywords

Compression bandages

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patient at risk of venous thrombosis

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Compression bandages application and interface pressure measurements

Intervention Description

Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher).

Primary Outcome Measure Information:

Title

Time Frame

Through study completion (one year)

Secondary Outcome Measure Information:

Title

Evaluation of the impact of soft tissue mechanical propreties on interface pressure

Description

Time Frame

Through study completion (one year)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female between 18 and 80 years old 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: Compression bandages contraindications 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pascal Giraux, MD, PhD

Organizational Affiliation

Service de Médecine Physique et de Réadaptation, CHU Saint-Etienne, France

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Médecine Physique et de Réadaptation, CHU Bellevue

City

Saint-Etienne

ZIP/Postal Code

42000

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

29037358

Citation

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.

Results Reference

derived

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Modelling Interface Pressure Applied by Superimposed Compression Bandages

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