Grade III/IV pressure ulcers Skin and Connective Tissue Diseases Decubitus ulcer
Conditions
Interventions
Participants will be randomised to receive TNP therapy or the comparator treatment (spun hydrocolloid, alginate or foam dressings). TNP therapy consists of a computer-controlled vacuum pump, into whic
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete healing of the pressure ulcer, to be assessed weekly. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Number of patients eligible (i.e. number meeting trial inclusion criteria) 2. Number of patients providing informed consent 3. Recruitment rates in primary and secondary care 4. Co-morbidities in recruited participants, assessed at baseline 5. Anatomical location of pressure ulcer and ulcer history, assessed at baseline 6. Incidence of wound infection at baseline 7. Pain 8. Frequency of dressing change and products used (resource use data) 9. Rates of hospital admission and discharge for study participants and discharge destination 10. Attrition rates 11. How are 12-item Short Form Health Survey (SF-12)/European Quality of Life Instrument (EQ-5D) data best collected from participants? Measured at baseline, 2 weeks, 1 month, 3 months and 6 months. 12. Amount of nurse training required in use of topical negative pressure therapy to support a trial 13. Adverse events 14. Nurses' opinions on documentation design 15. Training sessions required 16. Nurses' views of wound response impact on treatment choices All other outcomes to be assessed in an ongoing fashion throughout the trial. | — |
Countries
United Kingdom
Outcome results
None listed