Overview

This trial is active, not recruiting.

Condition lymphedema
Treatments precast adjustable compression wrap (circaid), multilayer compression bandages
Phase phase 4
Sponsor Parc de Salut Mar
Collaborator Hospital Universitari de Bellvitge
Start date February 2015
End date January 2016
Trial size 47 participants
Trial identifier NCT02369679, 2014/5584/I

Summary

Treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately.The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system.

The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
Precast Adjustable Compression Wrap will be adjusted by the physiotherapist each visit
precast adjustable compression wrap (circaid)
A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the precast adjustable compression wrap to the patient. The patient would maintain the precast adjustable compression wrap until the next session of treatment. The first 10 sessions will be daily from Monday to Friday. After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days).
(Active Comparator)
Multilayer Compression Bandages will be adjusted by the physiotherapist each visit
multilayer compression bandages
A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the multilayer bandage to the patient. The patient would maintain the multilayer compression bandage until the next session of treatment. The first 10 sessions will be daily from Monday to Friday. After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days).

Primary Outcomes

Measure
Change in the excess of volume of upper limb
time frame: Baseline to 3 months (10 sessions of treatment)

Secondary Outcomes

Measure
Changes in pain, heaviness, tightness and hardness
time frame: Baseline to 3 months (10 sessions of treatment)
Changes in skin and lymphedema condition
time frame: Baseline to 3 months (10 sessions of treatment)
Number of Participants with Serious and Non-Serious Adverse Events
time frame: Baseline to 3 months (10 sessions of treatment)

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Upper limb lymphedema after axillary lymph node dissection for breast cancer. - Lymphedema must affect at least the arm or the forearm. - The lymphedema volume excess must be at least 10% - The lymphedema must have not been previously treated or have been at least 1 year without treatment. Exclusion Criteria: - Bilateral upper limb lymphedema - Cognitive or sensorial impairments which could interfere collaboration - Plexopathy post radiotherapy - Breast cancer in progression Pregnancy or Lactation

Additional Information

Official title Comparison of the Effectiveness of a Precast Adjustable Compression Wrap With the Multilayer Compression Bandage in Upper Limb Lymphedema
Principal investigator Roser Belmonte, MD, PhD
Description The gold standard of the treatment of lymphedema is based on a combined program called complex decongestive therapy. The components of the complex decongestive therapy are skin care, kinesiotherapy, manual lymphatic drainage and compression. The compression with multilayer bandage has proved to be the most effective of these therapies when analyzed separately. With the multilayer compression bandage the upper limb lymphedema volume decreased a 37.2%. The multilayer bandage produces a gradient compression on the limb where distal pressure is higher than proximal pressure. Several materials are needed for the multilayer bandage, including tubular bandage lining, digit bandages, foam under-cast padding and multiple layers of short-stretch bandages to cover the entire limb. The Precast Adjustable Compression Wrap fits each patient through a Velcro system. Decreasing compression is achieved by controlling the tension applied to each Velcro through a visual color guide. The Precast Adjustable Compression Wrap has proved to be safe and effective to treat lower limb lymphedema, but there is little information about its effectiveness in the treatment of the upper limb lymphedema. The aim is to compare the effectiveness of a precast adjustable compression wrap (Circaid) with the multilayer compression bandages in the treatment of the upper limb lymphedema.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Parc de Salut Mar.