A randomised Trial of Autologous Blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in LEprosy: The TABLE trial.

Autor: Napit IB; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.; Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom., Shrestha D; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal., Choudhury S; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom., Gkini E; Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom., Ilozumba O; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom., Gill P; Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom., Bishop J; Birmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom., Neupane K; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal., Adhikari A; Anandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal., Sartori J; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom., Watson SI; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom., Lilford R; Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
Jazyk: angličtina
Zdroj: PLoS neglected tropical diseases [PLoS Negl Trop Dis] 2024 May 02; Vol. 18 (5), pp. e0012088. Date of Electronic Publication: 2024 May 02 (Print Publication: 2024).
DOI: 10.1371/journal.pntd.0012088
Abstrakt: Introduction: Autologous blood products like Platelet Rich Plasma (PRP) and Leukocyte and Platelets Rich Fibrin (L-PRF) have been used for many years across many types of skin ulcers. However, the effectiveness of autologous blood products on wound healing is not well established.
Methods: We evaluated the 'second generation' autologous product- Leukocyte and Platelet- Rich Fibrin (L-PRF). Our trial was undertaken on patients suffering from neuropathic leprosy ulcers at the Anandaban hospital which serves the entire country of Nepal. We conducted a 1:1 (n = 130) individually randomised trial of L-PRF (intervention) vs. normal saline dressing (control) to compare rate of healing and time to complete healing. Rate of healing was estimated using blind assessments of ulcer areas based on three different measurement methods. Time to complete healing was measured by the local unblinded clinicians and by blind assessment of ulcer images.
Results: The point estimates for both outcomes were favourable to L-PRF but the effect sizes were small. Unadjusted mean differences (intervention vs control) in mean daily healing rates (cm2) were respectively 0.012 (95% confidence interval 0.001 to 0.023, p = 0.027); 0.016 (0.004 to 0.027, p = 0.008) and 0.005 (-0.005 to 0.016, p = 0.313) across the three measurement methods. Time to complete healing at 42 days yielded Hazard Ratios (unadjusted) of 1.3 (0.8 to 2.1, p = 0.300) assessed by unblinded local clinicians and 1.2 (0.7 to 2.0, p = 0.462) on blind assessment.
Conclusion: Any benefit from L-PRF appears insufficient to justify routine use in care of neuropathic ulcers in leprosy.
Trial Registration: ISRCTN14933421. Date of trial registration: 16 June 2020.
Competing Interests: The authors have declared that no competing interests exist.
(Copyright: © 2024 Napit et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje