02691nas a2200301 4500000000100000008004100001260001200042653001600054653001800070100001200088700001500100700001600115700001200131700001500143700001100158700001300169700001400182700001500196700001400211700001300225700001400238245015100252856009900403300000900502490000700511520185700518022001402375 2024 d c05/202410aTABLE trial10aulcer healing1 aNapit I1 aShrestha D1 aChoudhury S1 aGkini E1 aIlozumba O1 aGill P1 aBishop J1 aNeupane K1 aAdhikari A1 aSartori J1 aWatson S1 aLilford R00aA randomised Trial of Autologous Blood products, leukocyte and platelet-rich fibrin (L-PRF), to promote ulcer healing in LEprosy: The TABLE trial. uhttps://journals.plos.org/plosntds/article/file?id=10.1371/journal.pntd.0012088&type=printable a1-190 v183 a

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.

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