Evidence map›Paper›PMID 38696527›Full record

Trial reportPLoS neglected tropical diseases2024

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

Indra B Napit, Dilip Shrestha, Sopna Choudhury, Eleni Gkini, Onaedo Ilozumba, Paramjit Gill, Jon Bishop, Karuna Neupane, Anju Adhikari, Jo Sartori and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Indra B NapitAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.ORCID 0000-0003-0622-880X
Dilip ShresthaAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.
Sopna ChoudhuryInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
Eleni GkiniBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
Onaedo IlozumbaInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
Paramjit GillDivision of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom.
Jon BishopBirmingham Clinical Trials Unit, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
Karuna NeupaneAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.
Anju AdhikariAnandaban Hospital, The Leprosy Mission Nepal, Kathmandu, Nepal.
Jo SartoriInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
Samuel I WatsonInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.
Richard LilfordInstitute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, United Kingdom.

Funding

NIHR ARC West MidlandsNIHR Senior InvestigatorUK Department of Health and Social Care
6 · The paper itself

Abstract

introductionAutologous 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.

methodsWe 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.

resultsThe 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.

conclusionAny benefit from L-PRF appears insufficient to justify routine use in care of neuropathic ulcers in leprosy.

trial registrationISRCTN14933421. Date of trial registration: 16 June 2020.

Indexed as

LeprosyPlatelet-Rich FibrinWound HealingAdolescentAdultAgedFemaleHumansLeukocytesMaleMiddle AgedNepalPlatelet-Rich PlasmaSkin UlcerTreatment OutcomeYoung Adult

Identifiers

PMID38696527
PMCPMC11093377

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.