None listed
Conditions
Brief summary
Chronic venous leg ulcers are a major health problem affecting approximately 1.1/1000 of the Western Australian population and previous community studies have shown that venous leg ulcers contribute to 50% of all wounds managed by community nurses. Although most leg ulcers will heal with compression bandages, approximately 20% fail to respond to this treatment possibly due to the presence of unhealthy tissue. Therefore this study is looking at two different types of debridement treatments used to breakdown the unhealthy tissue to encourage the dressings and compression bandaging to be more effective at healing the venous leg ulcers. Participants who have had a leg ulcer for more than 4 weeks but less than 5 years that have failed to respond to dressings and compression bandaging because of the presence of unhealthy tissue would be eligible to participate in the study. The participants after consent with be randomly assigned to either low frequency ultrasonic debridment or sharp debridement treatment on a weekly basis for a maximum of 12 weeks or less (if healing occurs before the 12 weeks) carried out by an experienced wound Nurse Practitoner and then have a silver dressing and compression bandaging applied. The wounds will be measured on a weekly basis using 3-dimensional laser digital planimetry system which is uploaded on a secured computer to allow automatic calculation of wound tissue volume including the percentage of reduction or increase. In addition the wound assessment and care plan will be completed using an electronic on-line secured platform (Comcare Wound Module) to analyse healing outcomes and costs for all treatments of all participants. Each participant will complete a quality of life assessment prior to commencement of treatment and on completion of the study. The study will analyse the healing rates for both debridement treatments, compare the healing rates of the two treatments to determine which treatment was more effective and analyse the cost of healing for the two treatments.
Interventions
Prior to any treatment, a Nurse Practitioner(NP) (with 5 years experience) will complete baseline wound assessment, vascular assessment (to determine ankle/brachial index and an absolute toe pressure to exclude arterial insufficiency) and the participant will complete a baseline quality of life questionnaire. Wound assessments will then be repeated weekly by the NP for 12 weeks or until the ulcer is healed at the Silver Chain wound clinic visit prior to treatment. Base-line and on-going wound
Prior to any treatment, a Nurse Practitioner(NP) (with 5 years experience) will complete baseline wound assessment, vascular assessment (to determine ankle/brachial index and an absolute toe pressure to exclude arterial insufficiency) and the participant will complete a baseline quality of life questionnaire. Wound assessments will then be repeated weekly by the NP for 12 weeks or until the ulcer is healed at the Silver Chain wound clinic visit prior to treatment. Base-line and on-going wound assessments will be recorded using a 3-dimensional laser digital planimetry system (Silhouette ARANZ) and Comcare Wound Module. The Silhouette planimetry system allows for accurate wound measurement. The NP will take a wound image using the 3-dimensional laser digital device which is uploaded on to a secured computer system. The outline of the image is then traced so as the program can then automatically calculate the wound tissue volume. Subsequent weekly wound volume calculations include the percentage of reduction or increase.and are automatically displayed on a wound healing graph to show the calculated variation in wound tissue volume. Comcare wound module is an electronic on-line wound assessment platform and is a secured database that facilitates assessment, care planning, analysis of healing outcomes and costs. Silhouette and Comcare assessment technologies will eliminate any data collection bias. Participants who are randomised to receive Low Frequency Ultrasonic Debridement (LFUD) will have topical lignocaine 4% applied to the wound bed for 20 minutes prior to debridement treatments. They will then receive LFUD which will be delivered at 30-50 kHz by a handheld Sonaca probe, using normal saline solution as the coupling medium. The LFU will then be applied to the wound bed via the probe for 20 seconds per mm square ulcer area. The LFUD will be performed weekly until necrosis, signs of critical colonisation or localised infected tissue are eliminated. An average of 4 to 6 treatments per participant is expected. After each LFUD treatment, a silver antimicrobial dressing will be applied with a secondary absorbent pad and compression bandaging as clinically indicated by vascular assessment and participant tolerance (30-40mmHg is the recommended pressure for venous leg ulcers). Although LFUD has been reported to be well tolerated when used in conjunction with topical anaesthetic, should a participant not tolerate the procedure the therapy will be discontinued and an intention to treat analysis will be conducted. If additional dressings are required between weekly NP treatments/reviews then this will be performed by the participants primary nurse who will adhere to the evidence based care plan established by the NP. All consumables used and nursing time taken to complete all wound care interventions for each participant will be recorded on their electronic Comcare Wound record. Participants will be followed up by the NP weekly for 12 weeks or until the ulcer has healed., if this occurs earlier. In addition to the clinical outcome measures, quality of life will be measured using the Charring Cross assessment questionnaire both at baseline and final week of treatment.
Sponsors
Wound Management Innovation CRC
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The inclusion criteria includes any participant who is currently receiving wound care by Silver Chain in the Perth Metropolitan area whose venous leg ulcer has been present for four weeks or longer and has failed to respond to autolytic debridement (hydration of necrotic tissue with dressings to facilitate spontaneous autolysis) or conservative sharp debridement and compression bandaging during the usual care period.. The ulcer measures 200mm x 200mm or less, confirmation of venous disease by an ankle brachial pressure index of 0.7-1.2 and/or an absolute toe pressure of 60mmHg or above, the ulcer presents with impaired healing, necrosis, signs and symptoms of critical colonisation or localised infection which is based on a set criteria established by the International Wound Infection Institute (Keast et al., 2014).
Exclusion criteria
Participants will be excluded if they are under 18 years of age, have symptoms of an overt infection including cellulitis, underlying osteomyelitis or atypical pathophysiology; their leg ulcer has been present for more than 5 years and is greater than 200 x 200mm in dimensions; they are currently receiving chemotherapy or radiation therapy or have an underlying bleeding disorder, end-stage co-morbidity, internal defibrillator or unstable International Normalised Ratio (INR); or the ulcer has undergone previous LFUD.
Outcome results
None listed