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Trial record 11 of 288 for:    Lymphedema

Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01096589
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : November 27, 2012
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
3M

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphedema
Interventions Device: 3M Coban 2 (Compression System)
Device: Comprilan
Enrollment 82
Recruitment Details

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.

Pre-assignment Details  
Arm/Group Title Arm 1 - 3M Oedema Reduction System Arm 2 - 3M Oedema Reduction System Arm 3 - 3M Oedema Reduction System Arm 4 - Commercial Compression System 5 Apps/wk
Hide Arm/Group Description

3M Oedema Reduction System - 2 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 3 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 5 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

Commercial Compression System 5 apps/wk

Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

Period Title: Overall Study
Started 22 20 22 18
Completed 18 18 18 15
Not Completed 4 2 4 3
Reason Not Completed
Adverse Event             2             1             2             1
Withdrawal by Subject             2             1             1             1
Compliance with protocol             0             0             1             0
found treatment exhausting             0             0             0             1
Arm/Group Title Arm 1 - 3M Oedema Reduction System Arm 2 - 3M Oedema Reduction System Arm 3 - 3M Oedema Reduction System Arm 4 - Commercial Compression System 5 Apps/wk Total
Hide Arm/Group Description

3M Oedema Reduction System - 2 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 3 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 5 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

Commercial Compression System 5 apps/wk

Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

Total of all reporting groups
Overall Number of Baseline Participants 22 20 22 18 82
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 22 participants 18 participants 82 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  68.2%
9
  45.0%
11
  50.0%
14
  77.8%
49
  59.8%
>=65 years
7
  31.8%
11
  55.0%
11
  50.0%
4
  22.2%
33
  40.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 20 participants 22 participants 18 participants 82 participants
59.73  (13.29) 61.85  (14.49) 62.27  (13.25) 56.22  (14.78) 60.16  (13.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 22 participants 18 participants 82 participants
Female
20
  90.9%
20
 100.0%
20
  90.9%
17
  94.4%
77
  93.9%
Male
2
   9.1%
0
   0.0%
2
   9.1%
1
   5.6%
5
   6.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 22 participants 20 participants 22 participants 18 participants 82 participants
United States 5 3 2 2 12
United Kingdom 17 17 20 16 70
1.Primary Outcome
Title Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
Hide Description [Not Specified]
Time Frame baseline and after 3 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Patients must have completed the first week.
Arm/Group Title Arm 1 - 3M Oedema Reduction System Arm 2 - 3M Oedema Reduction System Arm 3 - 3M Oedema Reduction System Arm 4 - Commercial Compression System 5 Apps/wk
Hide Arm/Group Description:

3M Oedema Reduction System - 2 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 3 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 5 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

Commercial Compression System 5 apps/wk

Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

Overall Number of Participants Analyzed 18 20 22 16
Mean (Standard Deviation)
Unit of Measure: % volume change measured in mL.
-14.56  (12.22) -7.09  (7.30) -10.24  (8.65) -9.84  (4.34)
2.Secondary Outcome
Title Assessment of Safety by Incidence of Adverse Events.
Hide Description [Not Specified]
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - 3M Coban 2 Arm 2 - 3M Coban 2 Arm 3 - 3M Coban 2 Arm 4 - Comprilan
Hide Arm/Group Description:

3M Coban 2 - 2 apps/wk

3M Coban 2 (Compression System): Nonwoven cohesive backing and foam.

3M Coban 2 - 3 apps/wk

3M Coban 2 (Compression System): Nonwoven cohesive backing and foam.

Arm 3 - 3M Coban 2 - 5 apps/wk

3M Coban 2 (Compression System): Nonwoven cohesive backing and foam.

Comprilan short-stretch bandage 5 apps/wk

Comprilan: Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

Overall Number of Participants Analyzed 22 20 22 18
Measure Type: Number
Unit of Measure: No. of treatment-emergent adverse events
13 11 14 10
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1 - 3M Oedema Reduction System Arm 2 - 3M Oedema Reduction System Arm 3 - 3M Oedema Reduction System Arm 4 - Commercial Compression System 5 Apps/wk
Hide Arm/Group Description

3M Oedema Reduction System - 2 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 3 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

3M Oedema Reduction System - 5 apps/wk

3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam.

Commercial Compression System 5 apps/wk

Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).

All-Cause Mortality
Arm 1 - 3M Oedema Reduction System Arm 2 - 3M Oedema Reduction System Arm 3 - 3M Oedema Reduction System Arm 4 - Commercial Compression System 5 Apps/wk
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1 - 3M Oedema Reduction System Arm 2 - 3M Oedema Reduction System Arm 3 - 3M Oedema Reduction System Arm 4 - Commercial Compression System 5 Apps/wk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/20 (0.00%)      0/22 (0.00%)      0/18 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 - 3M Oedema Reduction System Arm 2 - 3M Oedema Reduction System Arm 3 - 3M Oedema Reduction System Arm 4 - Commercial Compression System 5 Apps/wk
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/22 (59.09%)      11/20 (55.00%)      14/22 (63.64%)      10/18 (55.56%)    
Gastrointestinal disorders         
Food poisoning *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Nausea *  0/22 (0.00%)  0 0/20 (0.00%)  0 1/22 (4.55%)  1 0/18 (0.00%)  0
Gastric disorder *  0/22 (0.00%)  0 0/20 (0.00%)  0 1/22 (4.55%)  1 0/18 (0.00%)  0
General disorders         
Medical device discomfort *  2/22 (9.09%)  2 3/20 (15.00%)  5 2/22 (9.09%)  4 3/18 (16.67%)  6
Application site discomfort *  0/22 (0.00%)  0 1/20 (5.00%)  1 4/22 (18.18%)  5 2/18 (11.11%)  3
Application site irritation *  0/22 (0.00%)  0 2/20 (10.00%)  2 0/22 (0.00%)  0 0/18 (0.00%)  0
Application site reaction *  1/22 (4.55%)  1 1/20 (5.00%)  1 1/22 (4.55%)  1 1/18 (5.56%)  1
Application site erythema *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Application site paraethesia *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Application site swelling *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Discomfort *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Fibrosis *  0/22 (0.00%)  0 1/20 (5.00%)  1 0/22 (0.00%)  0 0/18 (0.00%)  0
Generalised oedema *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
oedema peripheral *  0/22 (0.00%)  0 0/20 (0.00%)  0 1/22 (4.55%)  1 0/18 (0.00%)  0
Application site vesicles *  1/22 (4.55%)  1 0/20 (0.00%)  0 1/22 (4.55%)  1 0/18 (0.00%)  0
Malaise *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Infections and infestations         
Folliculitis *  1/22 (4.55%)  2 0/20 (0.00%)  0 1/22 (4.55%)  1 0/18 (0.00%)  0
Gastroenteritis *  0/22 (0.00%)  0 1/20 (5.00%)  1 0/22 (0.00%)  0 0/18 (0.00%)  0
Clellulitis *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Injury, poisoning and procedural complications         
Joint sprain *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Open wound *  0/22 (0.00%)  0 1/20 (5.00%)  1 0/22 (0.00%)  0 0/18 (0.00%)  0
Excoriation *  1/22 (4.55%)  1 0/20 (0.00%)  0 1/22 (4.55%)  1 1/18 (5.56%)  1
Musculoskeletal and connective tissue disorders         
Pain in extremity *  2/22 (9.09%)  2 2/20 (10.00%)  4 0/22 (0.00%)  0 1/18 (5.56%)  1
Limb discomfort *  1/22 (4.55%)  1 0/20 (0.00%)  0 1/22 (4.55%)  1 0/18 (0.00%)  0
Musculoskeletal discomfort *  0/22 (0.00%)  0 1/20 (5.00%)  1 0/22 (0.00%)  0 0/18 (0.00%)  0
Musculoskeletal pain *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Musculoskeletal stiffness *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Osteoarthritis *  0/22 (0.00%)  0 1/20 (5.00%)  1 0/22 (0.00%)  0 0/18 (0.00%)  0
Rheumatoid arthritis *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Joint swelling *  0/22 (0.00%)  0 1/20 (5.00%)  1 1/22 (4.55%)  1 0/18 (0.00%)  0
Arthralgia *  0/22 (0.00%)  0 1/20 (5.00%)  1 0/22 (0.00%)  0 0/18 (0.00%)  0
Back pain *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Nervous system disorders         
Hypoaesthesia *  0/22 (0.00%)  0 1/20 (5.00%)  2 0/22 (0.00%)  0 0/18 (0.00%)  0
Neuralgia *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Psychiatric disorders         
Anxiety *  0/22 (0.00%)  0 0/20 (0.00%)  0 1/22 (4.55%)  1 0/18 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Dyspnoea *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Skin and subcutaneous tissue disorders         
Skin irritation *  3/22 (13.64%)  4 1/20 (5.00%)  3 0/22 (0.00%)  0 1/18 (5.56%)  1
Erythema *  1/22 (4.55%)  1 2/20 (10.00%)  4 0/22 (0.00%)  0 0/18 (0.00%)  0
Rash *  1/22 (4.55%)  1 1/20 (5.00%)  1 1/22 (4.55%)  1 0/18 (0.00%)  0
Rash macular *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Heat rash *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
Skin chapped *  1/22 (4.55%)  1 0/20 (0.00%)  0 0/22 (0.00%)  0 0/18 (0.00%)  0
Vascular disorders         
Peripheral coldness *  0/22 (0.00%)  0 1/20 (5.00%)  1 0/22 (0.00%)  0 0/18 (0.00%)  0
Peripheral vascular disorders *  0/22 (0.00%)  0 0/20 (0.00%)  0 0/22 (0.00%)  0 1/18 (5.56%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Prof. Christine Moffatt, Principal Investigator
Organization: Centre for Reasearch and Implementation of Clinical Practice (CRICP)
Phone: +44 20 73 51 14 11
Responsible Party: 3M
ClinicalTrials.gov Identifier: NCT01096589     History of Changes
Other Study ID Numbers: EU Study-05-000012
First Submitted: March 22, 2010
First Posted: March 31, 2010
Results First Submitted: July 20, 2012
Results First Posted: November 27, 2012
Last Update Posted: November 7, 2018