Negative Pressure Vs. Compression in Venous Ulcers

Bridged Vacuum Assisted Closure (VAC) With Compression vs. Compression Therapy in the Management of Venous Leg Ulcers: A Prospective Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Varicose Ulcer
• Intervention / Treatment: Device: Bridged V.A.C.® with compression therapy; Device: Conventional Compression Therapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland
    • Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bridged V.A.C.® with compression therapy; A vacuum assisted closure device will be placed on the ulcer. A compression dressing will be placed over the V.A.C.® device	Device: Bridged V.A.C.® with compression therapy; Patients randomised to receive Bridge VAC with compression dressings will be managed using ActiV.A.C. Therapy unit, with a continuous pressure of 125mmHg. A V.A.C.® Granufoam™ Bridge Dressing will be used instead of the tube connector. A Coban™ Lite compression dressing will be placed over the VAC dressing. The Bridge connector of the VAC will be used to tunnel underneath the Coban™ Lite till the upper edge of the dressing.
Active Comparator: Conventional compression therapy; 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).	Device: Conventional Compression Therapy; Patients randomised to receive compression dressings will be managed using Coban™ Lite compression dressings with underlying non-adherent wound contact layer (WCL) dressings. Under the supervision of the investigating clinician, the dressings will be applied by a wound care specialist nurse and changed once to three times per week (depending on amount of exudate), until full ulcer healing or up to 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to healing	The time taken for complete closure of the index ulcer or till the wound is judged suitable for skin grafting	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of ulcers healed	The proportion of index ulcers fully healed	12 weeks
Ulcer recurrence	Wound recurrence rates at six weeks, and three, six and 12 months of follow-up	12 months

Collaborators and Investigators

• Sponsor: Western Vascular Institute, Ireland
• Investigators: Principal Investigator: Sherif Sultan, MD, Western Vascular Institute, Ireland; Principal Investigator: Wael Tawfick, MD, Western Vascular Institute, Ireland

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2016
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: September 26, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): August 4, 2021
• Last Update Submitted That Met QC Criteria: August 3, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Varicose ulcer; Vacuum Assisted Closure; Compression Therapy; Negative Pressure
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Varicose Ulcer
• Other Study ID Numbers: BVACC-CCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD of primary and secondary outcomes, could be made available to other researchers by request, while maintaining participant confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No