A pilot randomised controlled trial of topical negative pressure therapy for grade III/IV pressure ulcers

Not Applicable

Completed

• Conditions: Grade III/IV pressure ulcers; Skin and Connective Tissue Diseases; Decubitus ulcer

• Registration Number: ISRCTN69032034
• Lead Sponsor: niversity of York (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Participants must receive primary care via Leeds Primary Care Trust
2. Participants must have a pressure ulcer graded III or IV according to the European Pressure Ulcer Advisory Panel Grading System. The pressure ulcer should contain at least 80% viable tissue, or have a very thin layer of slough (non-viable tissue) requiring no further debridement prior to use of topical negative pressure therapy. Ulcers from any anatomical site are eligible for inclusion. The ulcer to be followed-up for the duration of the trial will be known as the reference ulcer. If more than one eligible ulcer is present, the reference ulcer will be defined as the deepest ulcer. All eligible ulcers can be treated with topical negative pressure therapy where required.
3. The patient should be receiving adequate nutrition, as assessed by the nurse providing care
4. Patient must be able to give informed consent
5. Adults (aged 18 years or over), either male or female

Exclusion Criteria

1. Patients who are unable to give informed consent
2. Patients with very limited life expectancy, e.g. undergoing end stage palliative care
3. Patients with active systemic infection at baseline, defined by clinical and/or laboratory assessment
4. Patients being treated with the V.A.C.® Instill™ machine
5. Patients with any of the following pressure ulcer characteristics:
5.1. Presence of undermining in the pressure ulcer cavity, precluding the use of topical negative pressure therapy (i.e. the deepest point of ulcer cannot be measured)
5.2. Necrotic tissue, eschar or necrotic bone present
5.3. Malignant tissue in the wound
5.4. Pressure ulcers close to exposed blood vessels and/or organs, anastomotic sites and/or nerves
5.5. Pressure ulcers located where, in the opinion of the treating clinician, a vacuum seal cannot be obtained. e.g. the anus

Study & Design

• Study Type: Interventional
• Study Design: Not specified