Comparison of Two Types of Bandages in the Treatment of Lymphoedema

The Effectiveness of the Elastic Component of the Multilayer Bandage in the Treatment of Patients With Lymphedema at the University Hospital of Montpellier : a Randomised Clinical Study

The study is a cohort study of patients at the University Hospital during the first two days of intensive treatment. The patients are randomly divided into two groups (N=10).

Throughout the study, group A is treated with the multilayer elastic bandage while group B is bandaged with contention only. The bandages were applied on the first and second day and were maintained in place. The bandages were applied on the first and second day and were maintained for 24 hours. All patients performed 30 minutes of physical activity in the bandage on both days.

The evaluation is based on the volumetric difference, skin quality and quality of life of these patients

Study Overview

• Status: Completed
• Conditions: Lymphoedema

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • UHMontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population corresponds to patients with primary or secondary lymphedema receiving intensive decongestant treatment at the Montpellier University Hospital. Patients must be of legal age and have unilateral stage 2 or 3 lymphedema.

Description

Inclusion criteria:

• Adult with unilateral lower limb lymphoedema
• Stage 2 or 3 lymphoedema
• 1st intensive decongestant treatment
• Ability to sit on a cycloergometer

Exclusion criteria:

• Severe cardiac disease
• Infectious dermoepidermitis
• Bandage unbearable for the patient

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perimetry of the affected limb	The physiotherapist measures the perimeter of the limb with a tape measure	day 1
Perimetry of the affected limb	The physiotherapist measures the perimeter of the limb with a tape measure	Day 2
Volumetry of the affected limb	the volume is calculated using computer software.	day 1
Volumetry of the affected limb	the volume is calculated using computer software.	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life questionnaire	The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later	day 1
Quality of life questionnaire	The patient completes the Lymphoedema Quality of Life Questionnaire (LYMQUOL leg) on admission to the ward and by email one month later	one month later

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: nicolas Erdocio, student, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 20, 2022

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Chronic disease; Lymphology; reduction bandages
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: RECHMPL21_0620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No