None listed
Conditions
Brief summary
Venous leg ulcers (VLU) account for 80% of all leg ulcers. They adversely affect quality of life and exact a financial burden on individuals and the health care sector. The use of graduated compression is considered ‘gold standard’ for the treatment of venous leg ulceration. Negative pressure wound therapy (NPWT), used in the management of wounds, has been found to reduce time to healing. However, no robust studies exist which compare the healing rates of VLU treated with compression bandaging and NPWT as compared to those treated with compression bandaging alone. Aim: To investigate the effectiveness of NPWT and four layer compression bandaging (4LCB) as compared to 4LCB and usual treatment, for healing venous leg ulcers. Objectives: 1. To investigate the efficacy of NPWT dressings and 4LCB as compared to usual treatment and 4LCB for healing VLUs. 2. To determine the impact of a VLU and its treatment on quality of life (QoL). 3. To conduct a prospective economic analysis to determine the costs associated with healing VLUs and the effect on quality adjusted life years (QALYs). Method: A single site two arm RCT with 150 patients, randomised to two groups of 75 will be undertaken. Patients will receive NPWT dressings and 4 LCB or usual treatment (tulle gras wound contact layer and absorbent pad) and 4 LCB for 12 weeks, or less if healed prior to 12 weeks. Ulcerated legs will be graded according to the CEAP classification. The Silhouette (Trademark) (ARANZ) device will be used to collect measurements. The EQ-5D-5L Tool and the Charing Cross Venous Leg Ulcer Tool (CXVLU) will be used to determine the impact of the VLU and treatments on quality of life and quality adjusted life years. Statistical analysis of healing times and QoL will be performed using t-test and regression analysis. A prospective economic analysis will be performed to determine the costs associated with healing VLUs and QALY.
Interventions
The intervention group will receive washing of the limb and wound in potable water, application of moisturiser to the lower leg, conservative sharp wound debridement if necessary, application of a silicone negative pressure wound therapy dressing with battery operated pump (which applies 80mmHg continuous negative pressure (PICO Trademark) )and four layer compression bandaging. Acquired wound infection will be treated with nanocrystalline silver dressings. If patients are unable to tolerate nano
The intervention group will receive washing of the limb and wound in potable water, application of moisturiser to the lower leg, conservative sharp wound debridement if necessary, application of a silicone negative pressure wound therapy dressing with battery operated pump (which applies 80mmHg continuous negative pressure (PICO Trademark) )and four layer compression bandaging. Acquired wound infection will be treated with nanocrystalline silver dressings. If patients are unable to tolerate nanocrystalline silver (5% estimated), cadexomer iodine will be used. Wound washing, moisturising, debridement and dressing application will be attended by a registered nurse. The decision to perform wound debridement will be made by the treating registered nurse based on the presence of loose avascular tissue in the wound bed and whether in her clinical opinion it can be safely removed. The Silhouette (Trademark) (ARANZ) device will used to collect accurate, reproducible, laser calibrated, three dimensional wound measurements at weekly intervals. Dressings will be attended twice weekly for twelve weeks or until the treating registered nurse decides that the wound no longer requires dressing. Adherence to the treatment regime will be evidenced by an intact dressing at time of next treatment. Variations from this treatment will be documented in the participant's record. The Charing Cross Venous Leg Ulcer Tool will be used to determine the quality of life impact of a venous leg ulcer and each of the study treatments. The EQ-5D-5L tool will be used to measure quality adjusted life years. These self assessment tools will be completed at first, thirteenth and final treatments.
Sponsors
Sir Charles Gairdner Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients referred to the vascular service at Sir Charles Gairdner Hospital (SCGH), Western Australia for treatment of a venous leg ulcer which Measures >2cm2 and <20cm2. Ankle-brachial pressure index (ABPI) between 0.8-1.2 No muscle, tendon or bone visible Able to attend twice weekly clinics English-speaking Over 18 years of age.
Exclusion criteria
Diabetic neuropathy or atypical ulcer diagnosis Dementia Anticoagulant use Infection at recruitment Uncontrolled immunosuppressive disorders Previous negative pressure wound therapy use for that ulcer.
Outcome results
None listed