Negative Pressure Vs. Compression in Venous Ulcers

Varicose Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03688841
• Other study ID #: BVACC-CCD
• Status: Completed
• Phase: N/A
• Start date: January 19, 2016
• Est. completion date: December 1, 2020

Study information

• Verified date: August 2021
• Source: Western Vascular Institute, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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)

Related Conditions & MeSH terms

• Ulcer
• Varicose Ulcer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ireland	Department of Vascular Surgery, Western Vascular Institute, Galway University Hospital	Galway

Sponsors (1)

Lead Sponsor	Collaborator
Western Vascular Institute, Ireland

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of ulcers healed	The proportion of index ulcers fully healed	12 weeks
Secondary	Ulcer recurrence	Wound recurrence rates at six weeks, and three, six and 12 months of follow-up	12 months