Evidence map›Paper›PMID 32864435›Full record

ArticleLaryngoscope investigative otolaryngology2020

Topical fibroblast growth factor-2 for treatment of chronic tympanic membrane perforations.

Felipe Santos, Edina Shu, Daniel J Lee, David H Jung, Alicia M Quesnel, Konstantina M Stankovic, Dunia E Abdul-Aziz, Camden P Bay, Amy Quinkert, D Bradley Welling

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Laryngoscope investigative otolaryngology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06448039 (In-office Repair of Chronic Tympanic Membrane Perforations), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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.

NCT06448039 phase1 / phase2active not recruitingnot on this mapstarted 2024, after this paper: background citation

In-office Repair of Chronic Tympanic Membrane Perforations

TypeinterventionalSponsorD. Bradley Welling, MD, PhDRan2024 to 2026Enrolled20ConditionsChronic Tympanic Membrane PerforationArmsFibroblast Growth Factor 2, Saline control
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.

  1. The effectiveness and safety of growth factors in the treatment of tympanic membrane perforations: a systematic review and meta-analysis of randomized controlled trials.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2022
    Pooled it
  2. Article
  3. Adjunctive Serum Drops to Paper Patch for Tympanic Membrane Perforation.The Annals of otology, rhinology, and laryngology · 2026
    Article
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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

10 authors at 2 institutions in 1 country.

Felipe SantosDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.ORCID https://orcid.org/0000-0002-3523-665X
Edina ShuDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.ORCID https://orcid.org/0000-0002-4288-2983
Daniel J LeeDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.
David H JungDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.
Alicia M QuesnelDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.ORCID https://orcid.org/0000-0002-4075-0960
Konstantina M StankovicDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.
Dunia E Abdul-AzizDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.ORCID https://orcid.org/0000-0001-8323-5443
Camden P BayDepartment of Infectious Disease, Center for Clinical Investigation (CCI) Brigham and Women's Hospital Boston Massachusetts USA.
Amy QuinkertDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.
D Bradley WellingDepartment of Otolaryngology Head and Neck Surgery Harvard Medical School Boston Massachusetts USA.ORCID https://orcid.org/0000-0002-9963-469X
Massachusetts Eye and Ear Infirmary · USBrigham and Women's Hospital · US

Funding

The Harvard Clinical and Translational Science CenterUL1TR002541 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2018 to 2022
$93.0M
NCATS NIH HHS UL1 TR002541
6 · The paper itself

Abstract

objectiveTo determine the efficacy of fibroblast growth factor-2 (FGF-2) in treating chronic nonhealing tympanic membrane (TM) perforations.

methodDouble-blinded, randomized placebo controlled phase 2 clinical trial for patients with chronic TM perforations of more than 3 months duration with a cross-over arm. Patients received either FGF-2 or placebo (sterile water) saturated gelatin sponge in the perforation after rimming the perforation under topical anesthesia. The perforation was then covered with Tisseel fibrin glue. The primary endpoint was complete closure of the TM perforation. Secondary end points included change in hearing and partial TM closure rates. The TM was examined every 3 weeks with otoendoscopy for closure. The treatment was repeated if there was incomplete closure every 3 weeks up to a total of three treatments per arm.

resultsSeventy four patients were recruited for the study. Fifty seven met eligibility criteria and fifty four completed the study. Ten of 14 perforations closed completely in the placebo group (71.4%) and 23 of 40 perforations closed completely in the FGF-2 treatment group (57.5%),

conclusionNo statistically significant difference in tympanic membrane perforation closure rate was found between the FGF-2 and placebo groups. There were no differences in hearing outcomes between the groups. LEVEL OF EVIDENCE: 1b.

Indexed as

basic FGFbFGFchronic tympanic membrane perforationFGF2fibroblast growth factorgrowth factortympanic membranetympanic membrane perforation

Identifiers

PMID32864435
PMCPMC7444771
OpenAlexW3024733276

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.