Emil Schmidt Wound Care specialist SDHB - Otago

Transcription

1 Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds Krysa J, Schmidt E, Thomson I, van Rij A Emil Schmidt Wound Care specialist SDHB - Otago

2 Background Regular debridement maintains a healthy wound bed (1-3) which is a vital part of wound bed preparation (4) A number of studies have compared different debridement methods (5-6) Increasing body of evidence show that LFUD can be as effective and sometimes more effective than sharp/surgical debridement (7-8) Reduction in healing time, hospital stay and operating theatre time are some of the potential benefits of LFUD (8-9) Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.

3 We need more Evidence BUT as so often the quality of studies was variable Conclusion: We need more evidence

4 How does LFUD work Uses adjustable saline flow through a hand piece creating highly charged bubbles Antibacterial Action - Harmonic Shock Tissue selectivity through localized Cavitation and Streaming Tissue response + improved blood flow Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds Krysa J, Schmidt E, Thomson I, van Rij A

5 A quick demonstration Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

6 The aim of the study The aim of this prospective randomized study is to assess the benefit of LFUD as an adjunct in the management of acute and chronic lower limb wounds Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds. Krysa J, Schmidt E, Thomson I, van Rij A

7 Inclusion and Exclusion Criteria Inclusion criteria: All wounds of lower limb requiring debridement Exclusion criteria: Patient not able/willing to enter the trial and attend the follow up Biopsy confirmed skin malignancy or vasculitis Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

8 Method All patients, presenting to Dunedin hospital including outpatient departments with a lower limb acute or chronic wound requiring debridement will be asked to take part in the study Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

9 Debridement Debridement refers to sharp/surgical debridement or debridement with an autolytic agent Sharp/surgical debridement will be done by vascular surgeon or wound specialist nurse (WCNS) LFUD will be carried out by a WCNS twice weekly for 3 weeks The treatment course can be repeated if clinically indicated Type of anaesthetic will depend on level of discomfort This would include topical anaesthetic, local infiltration, regional or general anaesthetic Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

10 Randomisation The randomisation schedule has been prepared by the study statistician who will not be involved in patient recruitment, screening, or examination The statistician will be blinded to treatment codes until all primary analyses are completed Randomisation will be performed using stratified randomisation (e.g.neuropathic, ischaemic, venous, other) Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds. Krysa J, Schmidt E, Thomson I, van Rij A

11 Entry into trial wound requiring debridement Randomisation LFUD NO LFUD Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds. Krysa J, Schmidt E, Thomson I, van Rij A

12 Data Collection Data will be entered into a prospective database by a research nurse. Data collection will include demographic data Aetiology and location of the wound Wound classification e.g. Wagner, chronicity, comorbidities and previous interventions Pain before, during and after procedure Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

13 Primary and Secondary Outcome Primary outcome Time to complete wound healing Photograph will be assessed by 2 independent observers to confirm complete epithelialisation of the wound Secondary outcome Relative rate of wound healing (12, 24 and 52 weeks); length of hospital stay; operating theatre time and number of treatments Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

14 Sample size 63 participants would be needed with complete data in each arm Recruitment time Just started and can take up to 3 years Completion date 4 years from first recruitment Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

15 Early Observations We finally there good things take time (35 signatures) We learn as we travel the journey We learn from each other You can t always get what you want 1 Patient randomized - Yeah control group Great to have Sue our vascular research nurse on board Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

16 Early Observations it s a matter of balance A balance between extreme excitement and frustrations Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

17 Practical Challenges There are a few Setting time aside for USS (30 minutes) Out patient clinics Mo and Fr Hospital rooms are dark surgical light Nurses are very, very busy applying pain relief Patients expectations CSSD equipment turnaround time Prioritizing normal work with research Keeping in touch with the team Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds.krysa J, Schmidt E, Thomson I, van Rij A

18 Keeping in touch Per This is quite deep and Felt like bone, periost? I will debride it again next Monday, NPWT in place, gauze, No compression Prospective randomised trial of low frequency ultrasound debridement (LFUD) in management of lower limb wounds E, Thomson I, van Rij A

19 Thank you for listening New Zealand wound Care Society 7th Annual Conference "Wound Care A Matter of Balance" 21 to 23 May 2015 Marlborough Convention Centre Blenheim

20 References 1a. Adv Skin Wound Care Nov;16(6): Prevalence of lower-limb ulceration: a systematic review of prevalence studies. Graham ID 1, Harrison MB, Nelson EA, Lorimer K, Fisher 1. J Wound Care Nov;15(10): Reviewing the evidence for wound bed preparation. Dowsett C, Claxton K. 2. Nurs Stand Feb 15-21;26(24):51-2, 54, 56 passim. Debridement of diabetic foot wounds. Haycocks S, Chadwick P. 3. Prac Nurs 2011;22: Reviewing best practice in wound debridement. Young T. 4. Adv Skin Wound Care Nov-Dec;19(9):506-17; quiz Debridement: a vital component of wound bed preparation. Kirshen C, Woo K, Ayello EA, Sibbald RG. 5. J Wound Care Feb;18(2):54-6. Regular debridement is the main tool for maintaining a healthy wound bed in most chronic wounds. Wolcott RD, Kennedy JP, Dowd SE. 6. J Am Coll Surg Jul;183(1):61-4. Effect of extensive debridement and treatment on the healing of diabetic foot ulcers. Diabetic Ulcer Study Group. Steed DL, Donohoe D, Webster MW, Lindsley L. 7. J Surg Res Aug;176(2): doi: /j.jss Epub 2011 Dec 24. Effective method to remove wound bacteria: comparison of various debridement modalities in an in vivo porcine model. Nusbaum AG, Gil J, Rippy MK, Warne B, Valdes J, Claro A, Davis SC 8. Voigt J, Wendelken M, Driver V, Alvarez OM (2011) Low-frequency ultrasound (20 40kHz) as an adjunctive therapy for chronic wound healing: a systematic review of the literature and meta-analysis of eight randomized controlled trials. Int J Low Extrem Wounds 10: