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Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration:DAVE trial
- Source :
- Onida, S, Heatley, F, Peerbux, S, Bolton, L, Lane, T, Epstein, D, Gohel, M, Poskitt, K, Cullum, N, Norrie, J, Lee, R J, Bradbury, A, Dhillon, K, Chandrasekar, A, Lomas, R & Davies, A H 2021, ' Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration : DAVE trial ', BMJ Open, vol. 11, no. 4, e041748 . https://doi.org/10.1136/bmjopen-2020-041748, Digibug: Repositorio Institucional de la Universidad de Granada, Universidad de Granada (UGR), BMJ Open, Vol 11, Iss 4 (2021), BMJ Open, Digibug. Repositorio Institucional de la Universidad de Granada, instname
- Publication Year :
- 2021
-
Abstract
- This study is supported by the J P Moulton Charitable Foundation (grant number: N/A). The DCD allograft is provided free of charge by NHSBT.<br />The authors wish to thank the principal investigators, research nurses and their teams at the recruiting sites. The authors also wish to thank the NHS Blood and Transplant (NHSBT) for providing the DCD allograft free of charge and for their support in training clinical staff, and the NIHR Clinical Research Networks (CRNs) for their support in identifying sites. Finally, the authors wish to thank all individuals who participated in the PPI focus groups and extend a special thank you to PPI representative Emanuel Ezeife, whose useful feedback helped to inform the design of the study.<br />Introduction Venous leg ulceration (VLU), the most common type of chronic ulcer, can be difficult to heal and is a major cause of morbidity and reduced quality of life. Although compression bandaging is the principal treatment, it is time-consuming and bandage application requires specific training. There is evidence that intervention on superficial venous incompetence can help ulcer healing and recurrence, but this is not accessible to all patients. Hence, new treatments are required to address these chronic wounds. One possible adjuvant treatment for VLU is human decellularised dermis (DCD), a type of skin graft derived from skin from deceased tissue donors. Although DCD has the potential to promote ulcer healing, there is a paucity of data for its use in patients with VLU. Methods and analysis This is a multicentre, parallel group, pragmatic randomised controlled trial. One hundred and ninety-six patients with VLU will be randomly assigned to receive either the DCD allograft in addition to standard care or standard care alone. The primary outcome is the proportion of participants with a healed index ulcer at 12 weeks post-randomisation in each treatment arm. Secondary outcomes include the time to index ulcer healing and the proportion of participants with a healed index ulcer at 12 months. Changes in quality of life scores and cost-effectiveness will also be assessed. All analyses will be carried out on an intention-to-treat (ITT) basis. A mixed-effects, logistic regression on the outcome of the proportion of those with the index ulcer healed at 12 weeks will be performed. Secondary outcomes will be assessed using various statistical models appropriate to the distribution and nature of these outcomes. Ethics and dissemination Ethical approval was granted by the Bloomsbury Research Ethics Committee (19/LO/1271). Findings will be published in a peer-reviewed journal and presented at national and international conferences.<br />J P Moulton Charitable Foundation
- Subjects :
- medicine.medical_specialty
Cardiovascular Medicine
Logistic regression
vascular surgery
law.invention
1117 Public Health and Health Services
030207 dermatology & venereal diseases
03 medical and health sciences
0302 clinical medicine
Medicine, General & Internal
Quality of life
Randomized controlled trial
Standard care
law
Internal medicine
General & Internal Medicine
Medicine
Humans
Multicenter Studies as Topic
030212 general & internal medicine
wound management
Randomized Controlled Trials as Topic
Protocol (science)
Leg
Science & Technology
business.industry
1103 Clinical Sciences
General Medicine
vascular medicine
Dermis
Vascular surgery
Allografts
Quality of Life
Dermis Allograft
Neoplasm Recurrence, Local
business
Life Sciences & Biomedicine
Bandage
1199 Other Medical and Health Sciences
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Onida, S, Heatley, F, Peerbux, S, Bolton, L, Lane, T, Epstein, D, Gohel, M, Poskitt, K, Cullum, N, Norrie, J, Lee, R J, Bradbury, A, Dhillon, K, Chandrasekar, A, Lomas, R & Davies, A H 2021, ' Study protocol for a multicentre, randomised controlled trial to compare the use of the decellularised dermis allograft in addition to standard care versus standard care alone for the treatment of venous leg ulceration : DAVE trial ', BMJ Open, vol. 11, no. 4, e041748 . https://doi.org/10.1136/bmjopen-2020-041748, Digibug: Repositorio Institucional de la Universidad de Granada, Universidad de Granada (UGR), BMJ Open, Vol 11, Iss 4 (2021), BMJ Open, Digibug. Repositorio Institucional de la Universidad de Granada, instname
- Accession number :
- edsair.doi.dedup.....a9f592ac54a257818f40aaf338e3a95c