A prospective cohort study of the silk fibroin patch in chronic tympanic membrane perforation

Lee, Jun Ho; Kim, Chang Woo; Park, Hae Sang; Jeong, Ju Yeon; Yeon, Yeung Kyu; Kim, Jaebong; Bae, Sung Hee; Lee, Jung Min; Moon, Bo Mi

doi:10.1002/lary.25980

Cited by 24 publications

(20 citation statements)

References 23 publications

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“…Thin silk films have also been used in prospective human clinical trials to repair acute and chornic tympanic membrane perforations . These silk patches (Tympasil, Daewoong‐Bio, Seoul, South Korea) were generated using reverse engineered Bombyx mori silk fibroin.…”

Section: Clinical Trials Using Silkmentioning

confidence: 99%

“…The first clinical trial involved 52 patients with acute traumatic tympanic membrane perforation who were treated with either a silk film or a paper‐based membrane. [115b] A number of conservative treatment modalities had been explored to support the (often spontaneous) healing of an acutely perforated tympanic membrane, including the placement of a “patch” on top of the damaged tympanic membrane. In this trial, the silk or paper patches were surgically placed and removed 7 days later, when the tympanic membrane appeared fully regenerated.…”

Section: Clinical Trials Using Silkmentioning

confidence: 99%

“…A follow‐up study of 40 patients with chronic traumatic tympanic membrane perforation showed that patients treated with a silk patch (Tympasil) had lower otorrhea, minor complication rates, and high patient satisfaction when compared with conventional perichondrium myringoplasty. [115a] The silk and autologous patches were removed one week after placement, and the postoperative hearing outcomes were not significantly different between the two treatment groups. However, the surgical time for the silk patch was very short (13.7 vs 29.5 min) and no sourcing of connective tissue was required for the graft.…”

Section: Clinical Trials Using Silkmentioning

confidence: 99%

See 2 more Smart Citations

The Biomedical Use of Silk: Past, Present, Future

Holland

Numata

Rnjak‐Kovacina

et al. 2018

Adv Healthcare Materials

613

509

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Humans have long appreciated silk for its lustrous appeal and remarkable physical properties, yet as the mysteries of silk are unraveled, it becomes clear that this outstanding biopolymer is more than a high‐tech fiber. This progress report provides a critical but detailed insight into the biomedical use of silk. This journey begins with a historical perspective of silk and its uses, including the long‐standing desire to reverse engineer silk. Selected silk structure–function relationships are then examined to appreciate past and current silk challenges. From this, biocompatibility and biodegradation are reviewed with a specific focus of silk performance in humans. The current clinical uses of silk (e.g., sutures, surgical meshes, and fabrics) are discussed, as well as clinical trials (e.g., wound healing, tissue engineering) and emerging biomedical applications of silk across selected formats, such as silk solution, films, scaffolds, electrospun materials, hydrogels, and particles. The journey finishes with a look at the roadmap of next‐generation recombinant silks, especially the development pipeline of this new industry for clinical use.

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Section: Clinical Trials Using Silkmentioning

confidence: 99%

Section: Clinical Trials Using Silkmentioning

confidence: 99%

Section: Clinical Trials Using Silkmentioning

confidence: 99%

See 1 more Smart Citation

The Biomedical Use of Silk: Past, Present, Future

Holland

Numata

Rnjak‐Kovacina

et al. 2018

Adv Healthcare Materials

613

509

View full text Add to dashboard Cite

show abstract

“…Because we assured the advantage of synthetic biocomportable patch in this study, silk patch was tried in the other prospective cohort study: comparative analysis between silk patch and conventional perichondrial myringoplasty in chronic tympanic membrane perforation [6]. With these two clinical reports [6,7], we carefully suggested that the silk patch has advantage effect on healing process of perforated tympanic membrane even though acute or chronic condition.…”

mentioning

confidence: 99%

“…With these two clinical reports [6,7], we carefully suggested that the silk patch has advantage effect on healing process of perforated tympanic membrane even though acute or chronic condition.…”

mentioning

confidence: 99%

In Reply: Treatment for Acute Tympanic Membrane Perforation

Lee

Kim

et al. 2016

Clin Exp Otorhinolaryngol

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A Systematic Review of Nonautologous Graft Materials Used in Human Tympanoplasty

et al. 2020

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Objectives Nonautologous graft materials may solve several dilemmas in tympanoplasty by obviating the need for graft harvest, facilitating consistent wound healing, and permitting graft placement in the clinical setting. Prior studies of nonautologous grafts in humans have shown variable outcomes. In this systematic review, we aim to 1) summarize clinical outcomes and 2) discuss limitations in the literature regarding nonautologous grafts for tympanoplasty in humans. Methods A literature review was performed using the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) recommendations. The study size, etiology and duration of perforation, type of nonautologous graft, and postoperative closure rate were assessed. Results The PRISMA approach yielded 61 articles, including 3,247 ears that met inclusion criteria. Studies evaluated nonautologous grafts including paper patch, gelatin sponge, growth factors, porcine small‐intestinal submucosa, among others. Traumatic perforations (62.3%) were most commonly studied, whereas postinfectious perforations (31.9%) and other etiologies (5.8%) comprised a minority of cases. Acute perforations of <8 weeks duration constituted just over half of all treated ears. Overall closure rate was 82.1%, with significantly higher closure rates in acute (89.9%) versus chronic perforations (64.9%, P < .01), regardless of material. A median postoperative air‐bone gap of 5.6 dB was found in the 23% of studies reporting this metric. Conclusions The majority of publications reviewing nonautologous materials in tympanoplasty evaluate acute or traumatic perforations, and few rigorously report hearing outcomes. Given available data, porcine submucosa and basic fibroblast growth factor may hold promise for chronic perforation closure. Future studies should report closure rates and hearing outcomes in perforations >8 weeks duration. Laryngoscope, 131:392–400, 2021

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A prospective cohort study of the silk fibroin patch in chronic tympanic membrane perforation

Abstract: 2b Laryngoscope, 126:2798-2803, 2016.

Cited by 24 publications

References 23 publications

The Biomedical Use of Silk: Past, Present, Future

The Biomedical Use of Silk: Past, Present, Future

In Reply: Treatment for Acute Tympanic Membrane Perforation

A Systematic Review of Nonautologous Graft Materials Used in Human Tympanoplasty

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