2017
DOI: 10.1186/s12901-017-0038-8
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Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen

Abstract: BackgroundThis open-label study evaluated the safety and efficacy of a novel product for the removal of impacted cerumen in adult patients.MethodsThis was a prospective, single-center, single-arm, self-controlled clinical trial conducted in a community general practice setting. The novel product contains glycolic acid in an otologically-acceptable buffer containing sodium bicarbonate and glycerin and other buffering agents. The product was instilled into the ear canal prior to irrigation with warm water. Sever… Show more

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Cited by 9 publications
(6 citation statements)
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References 29 publications
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“…It affects 10% children and 5% adults. This disease is frequently underdiagnosed and has not been treated, although it has a relatively high proportion (Fullington et al, 2017). Fuad et al in their study in Kalesija, Bosnia and Herzuegowina community found 328 children with cerumen impaction and without significant difference of boys and girls prevalence (Brkic, 2010).…”
Section: Resultsmentioning
confidence: 99%
See 1 more Smart Citation
“…It affects 10% children and 5% adults. This disease is frequently underdiagnosed and has not been treated, although it has a relatively high proportion (Fullington et al, 2017). Fuad et al in their study in Kalesija, Bosnia and Herzuegowina community found 328 children with cerumen impaction and without significant difference of boys and girls prevalence (Brkic, 2010).…”
Section: Resultsmentioning
confidence: 99%
“…Cerumen impaction affects about 10% of children and 5% of adults. The disease is frequently underdiagnosed and not treated, although it has a relatively high proportion (Fullington et al, 2017).…”
Section: Introductionmentioning
confidence: 99%
“…[4,6] Products include acetic acid, triethanolamine, almond oil, camphor oil, glycerol and propylene glycol preparations. [4,7] These products are instilled in the ear canal several times a day for a few days and then the patient is recalled for removal. There is no consensus on guidelines of the methods of cerumen removal, either as single intervention or combined interventions.…”
Section: Introductionmentioning
confidence: 99%
“…Commonly used cerumenolytics include triethanolamine oleate, sodium bicarbonate, docusate sodium, hydrogen peroxide, carbamide peroxide, glycerol, chlorobutanol and paradichlorobenzene. 8 A Cochrane review in 2018 evaluating the efficacy of various cerumenolytics was inconclusive. 9 This might be due to carrying out only direct comparison meta-analysis where the pooled estimates were limited only to head-to-head comparisons.…”
mentioning
confidence: 99%