{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T14:51:30Z","timestamp":1776264690638,"version":"3.50.1"},"reference-count":12,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2020,5,14]],"date-time":"2020-05-14T00:00:00Z","timestamp":1589414400000},"content-version":"am","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2020,5,14]],"date-time":"2020-05-14T00:00:00Z","timestamp":1589414400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000005","name":"U.S. Department of Defense","doi-asserted-by":"publisher","award":["W81XWH\u201012\u20102\u20100125"],"award-info":[{"award-number":["W81XWH\u201012\u20102\u20100125"]}],"id":[{"id":"10.13039\/100000005","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007229","name":"Harvard University","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007229","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1TR002541"],"award-info":[{"award-number":["1TR002541"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100006108","name":"National Center for Advancing Translational Sciences","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006108","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007299","name":"Harvard Catalyst","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007299","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100007299","name":"Harvard Catalyst","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007299","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Laryngoscope Investig Oto"],"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>To determine the efficacy of fibroblast growth factor\u20102 (FGF\u20102) in treating chronic nonhealing tympanic membrane (TM) perforations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>Double\u2010blinded, randomized placebo controlled phase 2 clinical trial for patients with chronic TM perforations of more than 3\u2009months duration with a cross\u2010over arm. Patients received either FGF\u20102 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\u2009weeks with otoendoscopy for closure. The treatment was repeated if there was incomplete closure every 3\u2009weeks up to a total of three treatments per arm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seventy 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\u20102 treatment group (57.5%), <jats:italic>P<\/jats:italic> value = .36. Pure tone averages and word recognition scores were not statistically significantly different between study groups post\u2010treatment. After initial complete closure, re\u2010perforation occurred in seven FGF\u20102 treated patients and two placebo patients making the effective final closure rate 40% for FGF and 57% for placebo, respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>No statistically significant difference in tympanic membrane perforation closure rate was found between the FGF\u20102 and placebo groups. There were no differences in hearing outcomes between the groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Level of evidence<\/jats:title><jats:p>1b.<\/jats:p><\/jats:sec>","DOI":"10.1002\/lio2.395","type":"journal-article","created":{"date-parts":[[2020,5,14]],"date-time":"2020-05-14T09:41:43Z","timestamp":1589449303000},"page":"657-664","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["Topical fibroblast growth factor\u20102 for treatment of chronic tympanic membrane perforations"],"prefix":"10.1002","volume":"5","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3523-665X","authenticated-orcid":false,"given":"Felipe","family":"Santos","sequence":"first","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4288-2983","authenticated-orcid":false,"given":"Edina","family":"Shu","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel J.","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David H.","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4075-0960","authenticated-orcid":false,"given":"Alicia M.","family":"Quesnel","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Konstantina M.","family":"Stankovic","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8323-5443","authenticated-orcid":false,"given":"Dunia E.","family":"Abdul\u2010Aziz","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Camden P.","family":"Bay","sequence":"additional","affiliation":[{"name":"Department of Infectious Disease, Center for Clinical Investigation (CCI) Brigham and Women's Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amy","family":"Quinkert","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9963-469X","authenticated-orcid":false,"given":"D. Bradley","family":"Welling","sequence":"additional","affiliation":[{"name":"Department of Otolaryngology Head and Neck Surgery Harvard Medical School  Boston Massachusetts USA"},{"name":"Department of Infectious Disease Massachusetts Eye and Ear and Massachusetts General Hospital  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,5,14]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0000000000000616"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1093\/occmed\/41.2.86"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0194-5998(96)70008-6"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1288\/00005537-199512000-00007"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0b013e3181c34f01"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1097\/MAO.0b013e31822e0e53"},{"key":"e_1_2_9_8_1","unstructured":"Urbaniak G. C.; &PlousS.2013. Research Randomizer (Version 4.0) [Computer software]. Res Randomizer.https:\/\/www.randomizer.org\/. Accessed December 14 2016."},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.14639\/0392-100X-1480"},{"issue":"1","key":"e_1_2_9_10_1","first-page":"67","article-title":"Expression of fibroblast growth factor receptors 1\u20134 in human chronic tympanic membrane perforation","volume":"71","author":"Kakigi A","year":"2010","journal-title":"J Otorhinolaryngol Rel Spec"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1159\/000320612"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.3109\/00016489109137397"},{"key":"e_1_2_9_13_1","doi-asserted-by":"crossref","unstructured":"HakubaN HatoN OmoteharaY OkadaM GyoK.Epithelial pearl formation following tympanic membrane regeneration therapy using an atelocollagen\/silicone membrane and basic fibroblast growth factor: our experience from a retrospective study of one hundred sixteen patients.2013;38(5):394\u2010397.","DOI":"10.1111\/coa.12164"}],"container-title":["Laryngoscope Investigative Otolaryngology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Flio2.395","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lio2.395","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/lio2.395","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/am-pdf\/10.1002%2Flio2.395","content-type":"application\/pdf","content-version":"am","intended-application":"syndication"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lio2.395","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/lio2.395","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,2]],"date-time":"2023-09-02T08:49:05Z","timestamp":1693644545000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/lio2.395"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,5,14]]},"references-count":12,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2020,8]]}},"alternative-id":["10.1002\/lio2.395"],"URL":"https:\/\/doi.org\/10.1002\/lio2.395","archive":["Portico"],"relation":{},"ISSN":["2378-8038","2378-8038"],"issn-type":[{"value":"2378-8038","type":"print"},{"value":"2378-8038","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,5,14]]},"assertion":[{"value":"2020-03-26","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-04-28","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-05-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}