Venous leg ulcers, topical negative pressure and compression study

INTERVENTION: 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. CONDITION: Venous leg ulcers PRIMARY OUTCOME: Time to healing ie complete epithelialisation of the wound bed. This is assessed visually by the treating nurse and confirmed using the SIlhouette (Trademark) wound imaging device,where a wound area = 0 will indicate complete healing. SECONDARY OUTCOME: Differences in mean percentage healing between groups. Percentage healing is calculated for each wound by the Silhouette (Trademark) wound imaging device. The mean for each group will be calculated and t‐tests used to identify difference in mean between each group. Economic analysis of treatment outcomes and quality adjusted life years (QALYs). Data colletion will be undertaken using EQ‐5D‐5L and Charing Cross Venous Leg Ulcer Tool. Incidence of wound infection. ; Wound infection will be identified using criteria for identifying infection in chronic wounds publicised by the World Union of Wound Healing Societies (2008). These criteria are reproduced below. ; Localised infection ; New, increased or altered pain ; Delayed (or stalled) healing ; Periwound oedema ; Bleeding or friable (easily damaged) granulation tissue ; Distinctive malodour or change in odour ; Wound bed discoloration ; Increased or altered/purulent exudate ; Induration ; Pocketing ; Bridging ; Spreading infection: As for localised infection PLUS: ; Wound breakdown ; Erythema extending from wound edge ; Crepitus, warmth, induration or discoloration spreading into periwound area ; Lymphangitis ; Malaise or other non‐specific deterioration ; ; ; Wound infection will be confirmed by collection of wound swab and pathology report.. ; Quality of life (QoL) impacts. The EQ‐5D‐5L quality of life assessment tool and the Charing Cross Venous Leg Ulcer Tool will be used to assess quality of life. 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. ; (World Union of Wound Healing Societies. (2008). Principles of best practice: wound infection in clinical practice. an international consensus. Lomdon: MEP Ltd., p3. Retrieved 12 April 2016 from http://www.woundsinternational.com/media/issues/71/files/content_31.pdf.) 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.