Adjustable Compression Wraps (ACW) in Lymphedema

NCT ID: NCT07109674

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2025-03-30

Brief Summary

Compression therapy based on multilayer compression bandaging and com pression garment use remains the most efficient component of complex physical therapy (CPT) in lymphedema treatment. The proper self-application of compression bandages is generally considered as problematic. Adjustable compression wraps (ACW) have been proposed as an alternative to the commonly used short-stretch bandages for lymphedema. These systems allow easy application and removal for patients. They have been tested in patients with vascular disorders of the lower limbs and can be considered in breast cancer survivors with upper-limb lymphedema.

The objective of this study was to compare the effectiveness, physical functioning and comfort of 2 types inelastic compression: adjustable compression wrap (reduction) and multi-layer compression bandaging at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors.

Detailed Description

55 women after breast cancer treatment admitted to the Lymphedema Clinic and patients fulfilled the admission criteria - stage-II (according to ISL) lymphedema, ≥20% excess limb volumes, positive pitting skin sign, and absent signs of active cancer, venous thrombosis or previous compression were assigned into the experimental group with the adjustable compression wrap redcution kit, ACW - Group or the control with compression bandaging, CB-Group.

In the ACW reduction group, adjustable compression garments (typ circaid® reduction kit, Medi-Bayreuth) was also fitted based on individual limb measurements with ability to reduce size of garment as the limb volume decreases. The kit included a card with a color scale that allowed users to achieve the appropriate pressure of 20-30 mmHg. The next day, in order to refresh and moisturize the skin, these products were removed for a short period prior to the next therapeutic session. They were used for 24 hours.

In the CB group, multi-layer bandaging of the limb was performed using short stretch bandages with pads (Rosidal K, Lohmann & Raucher). At the beginning of bandaging, a cotton tube stockinet was placed on the arm, a layer of gauze was applied to the fingers and hand. A layer of foam padding (Lymphset: Lohmann & Raucher) was placed on the hand and wrapped around the arm. Three bandages of different sizes (8, 10, 12 cm in width) were placed around the limb with the first starting at the hand, the second at the wrist and the third beginning below the elbow. Sub-bandage pressure was measured via the Kikushime device (Kikgel, Ujazd Poland) on the dorsal part of the forearm, as well as on the arm, to ensure a pressure value within the range of 20-30 mmHg, comparable to pressure used in the compression system among the ACW Group. Bandages were removed for a short time before the therapeutic session the next day, as in the ACW-Group, and put on the next day. The exercise program including aerobic exercises of the upper limbs combined with deep breathing was performed in adjustable compression wraps or bandaging for 15 minutes in 1 session per day.

Measurements, including physical functioning, limb volumes and disease-related symptoms, were performed before the intervention and after treatment in both groups. Circumferential upper limb measurements were taken with the arm abducted at 30°, starting at the level of the ulnar styloid, every 4 cm proximal to this point along both limbs. Calculation of limb segment volumes was carried out using a simplified frustum formula (summed truncated cone). The excess volume was the difference between the affected and unaffected limbs expressed in litres. The percentage reduction of the excess volume was obtained as follows: (excess volume before treatment - excess volume after treatment) x 100/excess volume before treatment.

Patients rated their physical functioning, disease-related symptoms, compression comfort and complications of compression on a numerical rating scale (NRS) based on the International Compression Club (ICC) Questionnaire - Part for Patients. Firstly, the patients assessed their physical functioning (sum of ability to move wrist, elbow, shoulder; use a spoon; carry out work; complete household chores; practice sports' carry out leisure activities; social activities, on the Number Rating Scale (NRS; 0 = not able at all, 10 = completely able) and disease-related symptoms (sum of pain; loss of muscle strength; heaviness; swelling; tight skin; tingling; leakage; NRS: 0 = no complaints, 10 = the highest intensity), first without the tested compression and continued after 1 and 2 weeks using the compression device. Complications of compression related to skin irritation; tender spots; skin damage; itching; warmth; throbbing; cramps; cutting in; slippage; local swelling; bulky feeling; too tight feeling (NRS: 0 = not present at all, 10 = very obviously present, sum of points) were assessed after 1 and 2 weeks in both groups. Compression comfort including: easy donning; easy doffing; feeling immediately after donning; feeling during daytime; putting on clothes on compression; feeling at night; the appearance of the garment (NRS: 0 = not able at all, 10 = completely able, sum of points) was evaluated after the first and second weeks in both groups.

Treatment in both groups lasted 10 days (2 weeks, Monday to Friday). In the first week, all patients were treated by 2 experienced physiotherapists and educated in applying adjustable compression wraps (ACW reduction group) or self-bandaging (CB group). During the 2nd week, the use of ACW and CB was continued by the patients themselves at home. Patients were asked to maintain the adjustable compression wraps or compression bandaging even during the weekend (Saturday and Sunday).

Conditions

Lymphedema; Lymphedema Arm; Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Adjustable compression wrap-reduction kit

The objective of this study was to compare the effectiveness on volume reduction, physical functioning and comfort of inelastic compression: adjustable compression wrap (reduction) at the intensive phase of treatment in advanced upper limb lymphedema among breast cancer survivors

Group Type: EXPERIMENTAL

adjustable compression device (type circaid® reduction kit, Medi-Bayreuth)

Intervention Type: DEVICE

inelastic compression during intensive phase of physical therapy

Compression bandaging

text

Group Type: ACTIVE_COMPARATOR

Comparison of inelastic compression efficiency

Intervention Type: DEVICE

The effect of compression on volume reduction, physical functioning, disease-related symptoms and comfort

Interventions

adjustable compression device (type circaid® reduction kit, Medi-Bayreuth)

inelastic compression during intensive phase of physical therapy

Intervention Type: DEVICE

Comparison of inelastic compression efficiency

The effect of compression on volume reduction, physical functioning, disease-related symptoms and comfort

Intervention Type: DEVICE

Other Intervention Names

compression therapy

Eligibility Criteria

Inclusion Criteria

• stage-II of lymphedema (according to ISL)
• ≥20% excess limb volumes
• positive pitting skin sign
• absent signs of active cancer
• absent of venous thrombosis

Exclusion Criteria

• active cancer during oncological treatment
• using compression
• stage-I of lymphedema (according to ISL)
• < 20 % excess limb volumes

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University School of Physical Education, Krakow, Poland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University School of Physical Education

Krakow, Małopolska, Poland

Countries

Poland

References

Ochalek K, Kurpiewska J, Gradalski T. Adjustable Compression Wraps (ACW) vs. Compression Bandaging (CB) in the Acute Phase of Breast Cancer-Related Arm Lymphedema Management-A Prospective Randomized Study. Biology (Basel). 2023 Mar 31;12(4):534. doi: 10.3390/biology12040534.

Reference Type: BACKGROUND

PMID: 37106735 (View on PubMed)

Pujol-Blaya V, Salinas-Huertas S, Catasus ML, Pascual T, Belmonte R. Effectiveness of a precast adjustable compression system compared to multilayered compression bandages in the treatment of breast cancer-related lymphoedema: a randomized, single-blind clinical trial. Clin Rehabil. 2019 Apr;33(4):631-641. doi: 10.1177/0269215518821785. Epub 2019 Jan 4.

Reference Type: BACKGROUND

PMID: 30607986 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/37106735/

Effectiveness of a precast adjustable compression system compared to multilayerd compression bandaging in the treatment of breast cancer-related lymphedema

Other Identifiers

345/BS/IRK/2024

Identifier Type: -

Identifier Source: org_study_id