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| Name | Class |
|---|---|
| Hospital Universitari de Bellvitge | OTHER |
| Germans Trias i Pujol Hospital | OTHER |
| Hospital Vall d'Hebron | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precast Adjustable Compression Wrap | Experimental | Precast Adjustable Compression Wrap will be adjusted by the physiotherapist each visit |
|
| Multilayer Compression Bandages | Active Comparator | Multilayer Compression Bandages will be adjusted by the physiotherapist each visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precast Adjustable Compression Wrap (Circaid) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the excess of volume of upper limb | Change in the excess of volume of the affected upper limb. The excess of volume is the difference in volume between the affected and the unaffected upper limb. The upper limb volumes will be obtained from the perimeters of the upper limbs and applying the truncate cone formula. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months | Baseline to 3 months (10 sessions of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain, heaviness, tightness and hardness | Changes in pain, heaviness, tightness and hardness will be measured by visual analogical scales. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months | Baseline to 3 months (10 sessions of treatment) |
| Changes in skin and lymphedema condition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roser Belmonte, MD, PhD | Parc de Salut Mar | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Germans Trias i Pujol Hospital | Badalona | Barcelona | 08916 | Spain | ||
| Hospital Vall Hebron |
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| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Multilayer Compression Bandages | Device | 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). |
|
The skin and lymphedema condition will be evaluated every day along the treatment phase and at 3 months of follow up. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months |
| Baseline to 3 months (10 sessions of treatment) |
| Number of Participants with Serious and Non-Serious Adverse Events | Collection of adverse effects spontaneously reported by the participants and/or observed by the investigators. In order to evaluate tolerability patients will be asked every day about any discomfort or troubles they could feel. On the other hand, it will be daily recorded how many hours the patient had used the precast adjustable compression wrap or the multilayer compression bandages. Baseline to 2 weeks (10 sessions of treatment). A follow up at 3 months | Baseline to 3 months (10 sessions of treatment) |
| Barcelona |
| Barcelona |
| 08035 |
| Spain |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |