Evidence map›Paper›PMID 31615556›Full record

Trial reportJournal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale2019

Prospective pilot study of Floseal® for the treatment of anterior epistaxis in patients with hereditary hemorrhagic telangiectasia (HHT).

John M Lee, Vincent Wu, Marie E Faughnan, Andrea Lasso, Andrea Figol, Shaun J Kilty

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02638012 (Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.4field-weighted citation impact, top 17% of its field
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.

NCT02638012 nacompletednot on this map

Prospective Pilot Study of Floseal for the Treatment of Anterior Epistaxis in Patients With Hereditary Hemorrhagic Telangiectasia (HHT)

TypeinterventionalSponsorUnity Health TorontoRan2015 to 2019Enrolled8ConditionsHereditary Hemorrhagic Telangiectasia (HHT), EpistaxisArmsFloseal, Packing
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Hereditary haemorrhagic telangiectasia.Nature reviews. Disease primers · 2025
    Review
  3. Review
  4. Article
  5. Endoscopic surgical treatment of epistaxis in hereditary haemorrhagic telangiectasia: our experience.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2021
    Article
  6. 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

6 authors at 3 institutions in 1 country.

John M LeeDivision of Rhinology, Department of Otolaryngology - Head and Neck Surgery, St. Michael's Hospital, University of Toronto, 190 Elizabeth Street, Rm 3S-438, TGH RFE Building, Toronto, Canada.
Vincent WuDivision of Rhinology, Department of Otolaryngology - Head and Neck Surgery, St. Michael's Hospital, University of Toronto, 190 Elizabeth Street, Rm 3S-438, TGH RFE Building, Toronto, Canada. Vince.wu@mail.utoronto.ca.
Marie E FaughnanToronto HHT Centre, Division of Respirology, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, Canada.
Andrea LassoDepartment of Otolaryngology - Head and Neck Surgery, Ottawa Hospitals, University of Ottawa, Ottawa, Canada.
Andrea FigolDivision of Rhinology, Department of Otolaryngology - Head and Neck Surgery, St. Michael's Hospital, University of Toronto, 190 Elizabeth Street, Rm 3S-438, TGH RFE Building, Toronto, Canada.
Shaun J KiltyDepartment of Otolaryngology - Head and Neck Surgery, Ottawa Hospitals, University of Ottawa, Ottawa, Canada.
Ottawa Hospital · CASt. Michael's Hospital · CAUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEpistaxis is the most common symptom of hereditary hemorrhagic telangiectasia (HHT), affecting more than 98% of adults with HHT, with significant impact on quality of life. Floseal® has been shown to be effective for the management of anterior epistaxis, but has yet to be thoroughly evaluated in this population. Our goal was to evaluate the efficacy of Floseal® for managing acute anterior epistaxis in patients with HHT.

methodsA pilot prospective clinical trial was conducted at two tertiary referral centres, St. Michael's Hospital, Toronto, Canada and The Ottawa Hospital, Ottawa, Canada. All patients with HHT presenting with acute anterior epistaxis to the two study centres, who enrolled in the study, received Floseal® treatment. The primary outcome measures were achievement of hemostasis and changes in the Epistaxis Severity Score (ESS) between baseline and one-month follow up. Secondary outcome measure included clinical assessment of the nasal cavity.

resultsSeven patients were included in the final analysis. All patients underwent treatment of anterior epistaxis with Floseal® and achieved control of epistaxis within 15-min post-application. Application of Floseal® was well tolerated, with patients reporting a pain score of 3 ± 3.13 out of 10. There was no statistically significant difference noted in ESS scores pre-treatment and one-month follow up, 6.27 ± 2.42 vs. 4.50 ± 2.44, p = 0.179. There was a significant improvement clinically on exam of the nasal cavity between baseline and at one-month follow up, indicated by a decrease in the clinical assessment score, 17.29 ± 7.70 vs. 9.57 ± 7.81 (p = 0.0088).

conclusionsPatients with HHT presenting with acute epistaxis were able to achieve hemostasis with one application of Floseal®, with the procedure being very well tolerated with minimal pain. Although there was no significant change in ESS scores, clinical assessment of the nasal cavity revealed significant improvement at one-month follow up post treatment with Floseal®.

trial registrationThis multi-centered prospective clinical trial was registered with ClinicalTrials.gov ( NCT02638012 ). Registered on December 22, 2015.

Indexed as

EpistaxisFemaleGelatin Sponge, AbsorbableHemostatic TechniquesHumansMaleMiddle AgedPilot ProjectsProspective StudiesSelf ReportTelangiectasia, Hereditary HemorrhagicFloSeal MatrixEpistaxisFloseal®Hereditary hemorrhagic telangiectasiaHHT

Identifiers

PMID31615556
PMCPMC6794791
OpenAlexW2981067039

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

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.