Negative Pressure Vs. Compression in Venous Ulcers

NCT ID: NCT03688841

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-19
• Study Completion Date: 2020-12-01

Brief Summary

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.

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.

Conditions

Varicose Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Bridged V.A.C.® with compression therapy

Intervention Type: DEVICE

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.

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).

Group Type: ACTIVE_COMPARATOR

Conventional Compression Therapy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

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

Sponsors

Western Vascular Institute, Ireland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sherif Sultan, MD

Role: PRINCIPAL_INVESTIGATOR

Western Vascular Institute, Ireland

Wael Tawfick, MD

Role: PRINCIPAL_INVESTIGATOR

Western Vascular Institute, Ireland

Locations

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

Galway, , Ireland

Countries

Ireland

Other Identifiers

BVACC-CCD

Identifier Type: -

Identifier Source: org_study_id