Negative Pressure Vs. Compression in Venous Ulcers

NCT03688841 | Completed DMC

• 1 other identifier: BVACC-CCD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicose Ulcer

Keywords

Varicose ulcer; Compression Therapy; Negative Pressure; Vacuum Assisted Closure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Proportion of ulcers healed

  12 weeks

• Ulcer recurrence

  12 months

Study Arms (2)

Bridged V.A.C.® with compression therapy

EXPERIMENTAL

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

Conventional compression therapy

ACTIVE COMPARATOR

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

Interventions

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

Bridged V.A.C.® with compression therapy

Conventional Compression Therapy 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.

Conventional compression therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Western Vascular Institute, Ireland: lead

Study Sites (1)

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

Galway, Ireland

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sherif Sultan, MD

  Western Vascular Institute, Ireland

  PRINCIPAL INVESTIGATOR

• Wael Tawfick, MD

  Western Vascular Institute, Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the obvious differences between the intervention and comparator, it is impossible to blind the participants or the care providers. However, the investigator, the outcomes assessor and statistician are blinded to treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomised, parallel group, active-control trial, with patients randomised in a 1:1 ratio to one of two treatment arms.

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 28, 2018
• Study Start: January 19, 2016
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 4, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)