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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging.
Secondary objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - 3M Coban 2 | Experimental | 3M Coban 2 - 2 apps/wk |
|
| Arm 2 - 3M Coban 2 | Experimental | 3M Coban 2 - 3 apps/wk |
|
| Arm 3 - 3M Coban 2 | Experimental | Arm 3 - 3M Coban 2 - 5 apps/wk |
|
| Arm 4 - Comprilan | Active Comparator | Comprilan short-stretch bandage 5 apps/wk |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3M Coban 2 (Compression System) | Device | Nonwoven cohesive backing and foam. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. | baseline and after 3 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Safety by Incidence of Adverse Events. | 3 weeks |
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Inclusion Criteria (Arm):
Inclusion Criteria (Leg):
Exclusion Criteria (Arm):
Exclusion Criteria (Leg):
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| Name | Affiliation | Role |
|---|---|---|
| Christine Moffatt, Prof. | Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University Healthsystem | Evanston | Illinois | 60201 | United States | ||
| University of Missouri |
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Participants were randomly allocated to the 4 application frequencies for 19 days.
The randomisation was stratified according to limb location. Enroled participants were randomly assigned to one of the four treatment groups. Patients were treated in private lymphoedema clinics or in NHS centres (UK). US patients were treated in hospitals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - 3M Oedema Reduction System | 3M Oedema Reduction System - 2 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. |
| FG001 | Arm 2 - 3M Oedema Reduction System |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 3M Coban 2 (Compression System) |
| Device |
Nonwoven cohesive backing and foam. |
|
| 3M Coban 2 (Compression System) | Device | Nonwoven cohesive backing and foam. |
|
| Comprilan | Device | Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K). |
|
| Columbia |
| Missouri |
| 65203 |
| United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Memorial Hermann Hyperbaric Center | Houston | Texas | 77030 | United States |
| 56 London Road Clinic | Milborne Port | Dorset | DT9 5DW | United Kingdom |
| Kendal Lymphology Centre | Kendal | LA9 4BD | United Kingdom |
| LOROS Hospice | Leicester | LE3 9QE | United Kingdom |
| St Giles Hospice Lymphoedema Service | Lichfield | WS14 9LH | United Kingdom |
| Enfield Macmillan Lymphoedema Service | London | N9 7HD | United Kingdom |
| St Oswalds Hospice Lymphoedema Clinic | Newcastle upon Tyne | NE3 1EE | United Kingdom |
| Swansea Lymphoedema Service Singleton Hospital | Swansea | SA2 8QA | United Kingdom |
3M Oedema Reduction System - 3 apps/wk
3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.
| FG002 | Arm 3 - 3M Oedema Reduction System | 3M Oedema Reduction System - 5 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. |
| FG003 | Arm 4 - Commercial Compression System 5 Apps/wk | Commercial Compression System 5 apps/wk Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - 3M Oedema Reduction System | 3M Oedema Reduction System - 2 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. |
| BG001 | Arm 2 - 3M Oedema Reduction System | 3M Oedema Reduction System - 3 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. |
| BG002 | Arm 3 - 3M Oedema Reduction System | 3M Oedema Reduction System - 5 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. |
| BG003 | Arm 4 - Commercial Compression System 5 Apps/wk | Commercial Compression System 5 apps/wk Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. | Patients must have completed the first week. | Posted | Mean | Standard Deviation | % volume change measured in mL. | baseline and after 3 weeks of treatment |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Assessment of Safety by Incidence of Adverse Events. | Posted | Number | No. of treatment-emergent adverse events | 3 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - 3M Oedema Reduction System | 3M Oedema Reduction System - 2 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. | 0 | 22 | 13 | 22 | ||
| EG001 | Arm 2 - 3M Oedema Reduction System | 3M Oedema Reduction System - 3 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. | 0 | 20 | 11 | 20 | ||
| EG002 | Arm 3 - 3M Oedema Reduction System | 3M Oedema Reduction System - 5 apps/wk 3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam. | 0 | 22 | 14 | 22 | ||
| EG003 | Arm 4 - Commercial Compression System 5 Apps/wk | Commercial Compression System 5 apps/wk Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K). | 0 | 18 | 10 | 18 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medical device discomfort | General disorders | Non-systematic Assessment |
| ||
| Application site discomfort | General disorders | Non-systematic Assessment |
| ||
| Application site irritation | General disorders | Non-systematic Assessment |
| ||
| Application site reaction | General disorders | Non-systematic Assessment |
| ||
| Application site erythema | General disorders | Non-systematic Assessment |
| ||
| Application site paraethesia | General disorders | Non-systematic Assessment |
| ||
| Application site swelling | General disorders | Non-systematic Assessment |
| ||
| Discomfort | General disorders | Non-systematic Assessment |
| ||
| Fibrosis | General disorders | Non-systematic Assessment |
| ||
| Generalised oedema | General disorders | Non-systematic Assessment |
| ||
| oedema peripheral | General disorders | Non-systematic Assessment |
| ||
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Rash macular | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Limb discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Osteoarthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Joint sprain | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Open wound | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Food poisoning | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Folliculitis | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Non-systematic Assessment |
| ||
| Neuralgia | Nervous system disorders | Non-systematic Assessment |
| ||
| Peripheral coldness | Vascular disorders | Non-systematic Assessment |
| ||
| Peripheral vascular disorders | Vascular disorders | Non-systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Application site vesicles | General disorders | Non-systematic Assessment |
| ||
| Malaise | General disorders | Non-systematic Assessment |
| ||
| Heat rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Skin chapped | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
| ||
| Joint swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Excoriation | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Gastric disorder | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Clellulitis | Infections and infestations | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Christine Moffatt, Principal Investigator | Centre for Reasearch and Implementation of Clinical Practice (CRICP) | +44 20 73 51 14 11 | christine.moffatt@cricp.org.uk |
| ID | Term |
|---|---|
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| United Kingdom |
|
|
|