Community RCT of the Effectiveness of Two Compression Bandaging Technologies

Summary

Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed primarily through community home care services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is consensus in recent international, evidence-based practice guidelines that graduated, multi-layer compression is the most effective treatment, and greatly reduces healing time. High compression is more effective than low compression. However, there is no clear evidence as to which high compression technology is the most effective in promoting healing, the most acceptable to patients, or the most cost-effective to the health care system. This study is designed to answer these questions through a randomized trial conducted in the community, where most leg ulcer care currently takes place. Issues such as effectiveness in healing, quality of life, physical discomfort, personal preference, cost to the system and to the individual will be taken into consideration in evaluating two most commonly used types of compression bandaging.

Conditions

• Venous Ulcer

Interventions

DEVICE

Four-layer Bandage (Elastomeric)

Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week.

DEVICE

Short-stretch Bandage (Non-elastomeric)

These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Queen's University

  lead OTHER

Principal Investigators

• Margaret B Harrison, PhD · Queen's University

• Ian D Graham, PhD · University of Ottawa (co-investigator)

• Elizabeth A Nelson, PhD · University of Leeds, UK (co-investigator)

• Karen Lorimer, MNSc · Victorian Order of Nurses (co-investigator)

• Connie Harris, MNSc · ET NOW (co-investigator)

• Elizabeth VanDenKerkhof, PhD · School of Nursing, Queen's University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2004-01-31

Primary Completion

2008-03-31

Completion

2008-12-31

Countries

• Canada

Study Locations