Negative Pressure Vs. Compression in Venous Ulcers

Western Vascular Institute, Ireland

Status: Completed

Conditions: Varicose Ulcer

Treatments: Device: Bridged V.A.C.® with compression therapy; Device: Conventional Compression Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03688841

BVACC-CCD

Details and patient eligibility

About

This study randomises patients with venous leg ulcers, to be managed either using conventional compression bandages or a bridged vacuum assisted closure system under compression.

Full description

Venous ulcers are characterised by a cyclical pattern of healing and recurrence, with recurrence rates between 45 and 70% at one year. Venous leg ulceration has been identified as a common source of morbidity and reduced quality of life, especially in the elderly population. Non-healing ulcers place the patient at a much higher risk for lower extremity amputation.

Compression therapy is currently recognised as the main treatment for venous leg ulcers. External compression is applied as a therapy for venous leg ulcers, in an attempt to reverse the increased hydrostatic pressure in the veins.

The application of negative pressure to successfully treat and aid in the healing of open wounds has been studied extensively for decades, demonstrating favourable clinical results. However, there is a lack of evidence in the literature regarding the use of VAC in venous ulcers.

The combination of negative pressure therapy and compression therapy is theorized to provide the benefits of both individual therapies. As such, the utilization of the Bridge VAC under a compression dressing is expected to expedite the healing of venous ulcers.

The investigators aim to randomise patients with venous ulcers to either be managed using conventional compression dressings or combined bridge vacuum assisted closure with compression dressings.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years or more
• Provide written informed consent
• Venous ulcer present, greater than 10cm2 in surface area
• A C6 grading in the CEAP classification

Exclusion criteria

Pregnant (confirmed by β-HCG analysis). Female patients of childbearing potential are advised to adhere to an appropriate form of contraception, and those unwilling to follow contraceptive advice are excluded from the study

• Involvement in another clinical trial in the previous six months
• Legal incapacity
• Patient is bed-ridden or immobile
• Ulcer smaller than 10cm2 in surface area
• Ischaemic ulcer/s present
• Diabetic ulcer/s present
• Malignant ulceration/s present
• Ulcer exposing bone or tendon
• Osteomyelitis
• Pseudomonas infection
• Presence of gangrene
• Deep venous thrombosis (DVT) present
• Connective tissue disease present
• Presence of any illness that could limit long-term compliance (e.g. epilepsy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Bridged V.A.C.® with compression therapy

Experimental group

Description:

A vacuum assisted closure device will be placed on the ulcer. A compression dressing will be placed over the V.A.C.® device

Treatment:

Device: Bridged V.A.C.® with compression therapy

Conventional compression therapy

Active Comparator group

Description:

A Coban™ Lite compression dressings with underlying non-adherent wound contact layer (WCL) dressings will be applied and changed once to three times per week (dependant on exudate).

Treatment:

Device: Conventional Compression Therapy