The latest progress of tympanic membrane repair materials.

Tympanic membrane perforation is a common disease in otolaryngology, manifested as hearing loss, chronic infection, and often caused by middle ear trauma and infection. Choosing suitable repair materials to repair the perforation of the tympanic membrane is to achieve the purpose of improving the hearing of the patient and improving the discharge of pus. Autologous tissues, such as tragus perichondrium, temporal muscle fascia, tragus cartilage, fat, etc., are commonly used in clinical repair materials, and other materials include foreign bodies and allogeneic materials. Others include foreign bodies and foreign body materials. With the development of medicine and tissue engineering, many synthetic materials have achieved good results in repairing the tympanic membrane and improving hearing. The combined 3D printing technology of tympanic membrane regeneration and bioengineering aims to improve the success rate of surgery, increase the availability of different stents, and provide innovation repair materials and simplify surgical techniques (Sagiv et al., 2020 [1]). This article aims to describe the latest developments in the repair of tympanic membranes with autologous materials, foreign bodies and foreign materials, and artificial synthetic materials.

Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.

BACKGROUND AND AIM: Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries. METHODS AND MATERIALS: In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS. RESULTS: Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05). CONCLUSION: Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.

Bacterial cellulose graft versus fat graft in closure of tympanic membrane perforation.

OBJECT: To compare between results of bacterial cellulose graft myringoplasty and fat graft myingoplasty in patients had mild or moderate size safe perforation. METHODS: 120 patients undergoing myringoplasty due to mild or moderate size perforation were divided into 3 groups: group I: 40 patients undergoing myringoplasty with use of bacterial cellulose graft, group II: 40 patients undergoing myringoplasty with use of fat graft, group III: 40 patients undergoing usual myringoplasty with use of temporalis fascia graft (control group). RESULTS: Healing in 20 patients with small perforation and 17 patients with moderate perforation in Group I, Healing in 15 patients with small perforation and 10 patients with moderate perforation in Group II, Healing in 18 patients with small perforation and 12 patients with moderate perforation in Group III. CONCLUSION: Bacterial cellulose graft myringoplasty would be a good, simple, rapid and safe surgery that could be done under local anesthesia in outpatient clinic with shorter time of surgery than fat graft myringoplasty and temporalis fascia graft myringoplasty, with better hearing and healing. SUMMARY AT GLANCE: 120 patients undergoing myringoplasty were divided into 3 groups to compare between results of bacterial cellulose graft myringoplasty, fat graft myringoplasty and temporalis fascia graft myringoplasty.

Anatomical, functional and quality-of-life results for mastoid and epitympanic obliteration with bioactive glass s53p4: a prospective clinical study.

OBJECTIVE: To analyse the anatomical, functional and quality-of-life results when using bioactive glass in mastoid and epitympanic obliteration. DESIGN: Prospective clinical study. SETTING: Tertiary referral centre. PARTICIPANTS: Forty-one cases (39 patients) operated between May 2013 and January 2015. MAIN OUTCOME MEASURES: Anatomical results were evaluated by otomicroscopy 1 year after surgery and using imaging to detect residual disease. Functional results were studied by postoperative hearing gain. Quality of life was assessed with the Glasgow Benefit Inventory questionnaire and the success of surgery by a surgery-specific questionnaire. RESULTS: At 1 year, all patients presented a well-healed external auditory canal, with an intact tympanic membrane. In cases with cholesteatoma (n = 23), no recurrent retraction pockets or residual disease were observed on imaging studies. The overall air-bone gap closure was 7.7 ± 1.84 dB (mean ± se of the mean, P < 0.001, paired t-test). No significant differences were found on hearing results when comparing primary versus revision surgery, canal-wall-up versus canal-wall-down obliterations, type of tympanoplasty and presence of cholesteatoma (multifactor anova). The Glasgow Benefit Inventory improved with an average score of 28 and the success of surgery questionnaire showed a significant improvement in ear discharge and a moderate improvement in hearing and equilibrium. CONCLUSIONS: The use of bioactive glass for mastoid and epitympanic obliteration in canal-wall-down or canal-wall-up tympanoplasties is an effective procedure in both primary and revision surgery. The anatomical and functional results appear to be well correlated with patient experience and to the improvement in quality of life.

Safety and Efficacy of Chitosan-Dextran Hydrogel in the Middle Ear in an Animal Model.

OBJECTIVES: To investigate the efficacy of chitosan-dextran hydrogel (CDH) in preventing postoperative adhesions between the tympanic membrane (TM) and intratympanic structures, and to evaluate its ototoxicity in an animal study. METHODS: In the first step, ototoxicity was evaluated with 7 male albino guinea pigs (GPs) via auditory brainstem responses (ABR) before and 4 weeks after unilateral intratympanic injection of CDH and saline solution contralaterally. In the second step, 12 GPs underwent bilateral ear surgery. The middle ear (ME) mucosa was abraded, and the cavity was filled with CDH on one side and packed with Gelfoam on the contralateral side. A control group of 6 GPs underwent the same procedure except that no material was applied in the ME. The animals were euthanized at the end of the 7th week, and otomicroscopic findings were noted and the temporal bones harvested for the histologic examination. The findings were scored and compared. RESULTS: There was no statistically significant difference between the pre- and postoperative ABR thresholds. In the otomicroscopic findings, the most prominent difference between the two groups was the presence of retraction of the TM in the Gelfoam group. The histopathologic findings revealed a higher degree of inflammation in the Gelfoam group compared with the CDH group. CONCLUSION: This study demonstrated that CDH has no ototoxic effects in GPs. Its use as an ME packing material revealed significantly less TM retraction and inflammatory reaction compared with Gelfoam.

A trans-well-based cellular model for the rapid pre-evaluation of tympanic membrane repair materials.

It is important to have a standardized tympanic membrane (TM) perforation platform to evaluate the various myringoplasty materials that have been studied and developed extensively during recent years. However, currently there are no cellular models specifically designed for this purpose, and animal models remain unsatisfactory. The purpose of this study is to propose an inexpensive, readily available, well-controlled, and easy-to-create cellular model as a substitute for use in the evaluation of TM repairing materials. A trans-well model was created using a cell culture insert with a round hole created at the center of the polycarbonate membrane. HaCaT cells were cultured on the fenestrated culture insert, and the desired myringoplasty graft was placed at the center of the window for one week and observed by fluorescent microscopy under vital staining. Under this cellular model, there was notable migration of HaCaT cells onto the positive control graft (rabbit fascia), while only a few cell clusters were observed on the negative control graft (paper). Model validation showed that the cell migration ratio for the PLLA + 1% hyaluronic acid (HA) graft is significantly higher than using myringoplasty paper, poly L-lactide (PLLA), or PLLA + 0.5% HA (p < 0.05). This trans-well-based cellular model might be a useful pre-evaluation platform for the evaluation of TM repairing materials. The model is inexpensive, readily available, easy to create, and standardized for use.

The Otalgia Point: A Novel Clinical Gesture in Otolaryngology.

INTRODUCTION: In cases of otalgia without any accompanying findings, some patients locate their otalgia below the attachment of the lobule, at the apex of the jugulodigastric region. PURPOSE: To present a series of these patients for whom nasal steroids or myringotomy usually ameliorated their pain. MATERIALS AND METHODS: Thirty-two patients with normal physical examinations, tympanograms, and age-appropriate audiograms spontaneously indicated otalgia at "the otalgia point." Inspection of the oropharynx and nasal airway, palpation of the neck and temporal mandibular joints, and nasopharyngoscopy/laryngoscopy ruled out referred causes of otalgia. Patients were offered either nasal steroid spray or trial myringotomy followed by tympanostomy tube. RESULTS: Otalgia improved in all 10 (100%) patients who selected nasal steroids. Otalgia resolved in 17 of 20 (85%) myringotomy participants. Three patients declined intervention. In all, symptoms improved in 27/29 treated patients (93%). CONCLUSION: This description of "the otalgia point" introduces a new otolaryngologic gesture in physical examination that can aid in the therapeutic management of some patients with otalgia and normal examinations. This is an uncontrolled case series that serves as a pilot study for further exploration of this gesture.

Osteomyelitis of the Temporomandibular Joint Following Canal Wall Down Mastoidectomy.

Osteomyelitis of the temporomandibular joint (TMJ) is a rare disease that is characterized by osteitis of the mandibular condyle or glenoid fossa. Although this condition is usually associated with trauma, dental disease, or extension of a local infection, it may also occur as a complication of otologic infection. However, osteomyelitis of the TMJ as a complication of otologic surgery has not yet been reported. I present the case of a 54-year-old woman who developed a polyp on the superior portion of the tympanic membrane 9 weeks after canal wall down mastoidectomy. This is an extremely rare case of a patient with osteomyelitis of the TMJ as a complication of otologic surgery.

A prospective controlled trial comparing spontaneous closure and Epifilm® patching in traumatic tympanic membrane perforations.

The objective was to compare the outcomes of spontaneous closure and hyaluronic acid (HA) ester patching (Epifilm®) in subjects with traumatic tympanic membrane (TM) perforation. This was a prospective, controlled study performed at a tertiary teaching and research hospital. During 6-month period, subjects were divided into spontaneous closure (group A) and HA ester patch-Epifilm® (group B) group. Demographic data, presenting symptoms, closure rate, closure time and audiometric data were evaluated and compared between groups. In total, 155 subjects were evaluated. Group A consisted of 62.6 % (n = 97) of the subjects, whereas group B consisted of 37.4 % (n = 58) of the subjects. Group B had significantly shorter closure times when compared with group A (6.61 ± 4.59 vs. 10.60 ± 5.23 weeks, p = 0.001). When the closure time was evaluated according to perforation size both grade 1 and 2 perforations have significantly shorter closure times when compared with group A (6.33 ± 4.54 vs. 10.80 ± 5.69 weeks, for grade 1 and 6.650 ± 2.07 vs. 10.30 ± 4.32 weeks for grade 2 perforations). Closure rates were not significant between groups (85.6 % for group A and 94.8 % for group B). When the closure rate was evaluated according to perforation size no significant difference exists for grade 1, 2 and 3 perforations between groups. Both air conduction and air-bone gap were significantly improved in both groups. HA ester patch (Epifilm®) is a non-toxic material that can be used in traumatic tympanic membrane perforations. In this study, use of HA ester patching was resulted with earlier closure time but not resulted with higher closure rates.

An Innovative Tympanoplasty-Sleeve&Tongue Technique.

An innovative tympanoplasty method, blending the merits of traditional overlay and underlay techniques while avoiding the pitfalls. It enhances visualization, facilitates placement of the graft and preserves excellent blood supply, helps secure the fascia in place, as well as preserves the central-dented conical shape of the tympanic membrane. Laryngoscope, 133:3139-3143, 2023.

[The currently available possibilities for fixation of many-layer transplants in myringoplasty].

The objective of the present study was to improve the quality and efficacy of the surgical treatment of chronic otitis media including the plastic correction of total and subtotal tympanic defects by fixing a many-layer chondro-perichondrial autograft with the use of a latex tissue glue. Twenty seven patients presenting with total and subtotal defects of the tympanic membrane underwent surgical intervention in the lateral position. The multilayer transplants composed of a thinned cartilage, fascia, and transposed circular cutaneous graft on the feeding pedicle were fixed using the latex tissue glue. The morphological and functional results of the treatment were estimated one year after surgery. It was shown that the use of the latex tissue glue for the fixation of many-layer autografts during myringoplasty made it possible to decrease the duration of the hospital stay of the patients, reduce to a minimum manifestations of negative subjective feelings, and ensure the reliable clinico-morphological and functional outcome of the treatment.

An Ameloblastoma in the Middle Ear.

An ameloblastoma is a locally aggressive odontogenic tumour that commonly develops from the odontogenic epithelium within the jawbone. Here we present for the first time a case of a rare primary ameloblastoma in the middle ear cavity, along with some consideration of its treatment and a new classification. A 65-year-old woman presented with a left middle ear cavity tumour. Pathological examination led to the diagnosis of an ameloblastoma. We resected the tumour along with an extensive part of the middle ear mucosa, which made it difficult to have an adequate margin. It is recommended that the remaining bone be ground 2-3 mm beyond the visible margin after resecting the gross tumour. Therefore, several cases are treated with conservative surgery, including physicochemical treatment. This factor should be considered when designing treatment strategies as good alternatives in cases where resection with an adequate margin is difficult.

Prospective cohort comparison of bioactive glass implants and conchal cartilage in reconstruction of the posterior canal wall during tympanomastoidectomy.

OBJECTIVE: To compare the effectiveness of bioactive glass implants and conchal cartilage in reconstructing the posterior canal wall during tympanomastoidectomy. STUDY DESIGN: Prospective cohort clinical study. SETTING: Teaching hospital. PATIENTS: Patients with clinically diagnosed chronic suppurative otitis media and cholesteatoma awaiting tympanomastoidectomy were recruited. INTERVENTION: All patients underwent tympanomastoidectomy by the same surgeon. A first cohort of 12 patients underwent posterior canal wall reconstruction with autogenous conchal cartilage. A second cohort of 12 patients underwent such reconstruction with prefabricated bioactive glass. MAIN OUTCOME MEASURES: Primary- All patients underwent out-patient review at 1, 3, 6 and 12 months postoperatively, after which a second-look procedure was performed. Reconstructions were inspected for evidence of epithelialization, granulation, infection, stenosis, depression and extrusion. Secondary- All patients had perioperative serial pure-tone audiometry to check for any change in hearing levels upto 1 year postoperatively. RESULTS: By 1 year postoperatively, both reconstructive graft materials showed good epithelialization, no granulation, no infection, no ear canal stenosis, no depression and no extrusion. At operative second-looks, bioactive glass particularly showed good tissue bonding, including both neovascularization and connective tissue integration. Overall clinical outcome was equivalent for both materials. Both graft materials showed no statistically significant difference in postoperative hearing levels. CONCLUSIONS: Bioactive glass and conchal cartilage showed equivalent clinical outcome in reconstructing the posterior canal wall without significantly affecting hearing levels. As bioactive glass does not require second site morbidity and thus also reduces operative time, we prefer it for reconstructing the posterior canal wall following tympanomastoidectomy.

Combination of ionomer cement and bone graft for ossicular reconstruction.

The aim of this study was to investigate the efficacy of the reconstruction of large ossicular chain defects with a combination of ionomer cement and an autogenous cortical bone graft. Different individual solutions are described if at least the handle of the malleus is present: restoration of a large defect of the long process of the incus, formation of the incus body and the long process, and replacement of the missing superstructure of the stapes with a short bone graft standing on the footplate. In a unique case, total reconstruction of the malleus handle was carried out. In further cases where the malleus and the incus were absent, the missing superstucture of the stapes was replaced by a bone graft fixed to the remnant of the anterior crus, supplemented with a cortical bone PORP. Between 1993 and 2005, 84 patients underwent middle ear operations with the use of ionomer cement. In 16 ears (9 males, 7 females), a combination of ionomer cement and autogenous cortical bone graft was used for ossicular reconstruction, with a documented follow-up of at least 6 months to 7 years. All operations were performed under general anesthesia. The components of the cement were mixed by hand and transferred to the bare bone surface with a curved needle. Complex structures were built up step by step. In seven cases, the tympanic membrane was simultaneously reconstructed. The postoperative air-bone gap was < 20 dB in 11/16, 68% of the cases. No columella rejection occurred. The reconstructed malleus handle is still intact, though the hearing has deteriorated. The audiological results are encouraging and a further prospective study is under design in order to analyze the efficacy of the combination of ionomer cement and an autogenous cortical bone graft for ossicular reconstruction. The simultaneous reconstruction of the superstructure of the stapes and the long process of the incus or the whole incus makes PORPs or TORPs superfluous, if at least the handle of the malleus is present.

Regenerative treatment for tympanic membrane perforation using gelatin sponge with basic fibroblast growth factor.

OBJECTIVE: The objective of this study was to evaluate safety and efficacy of regenerative treatment using gelatin sponge with basic fibroblast growth factor (bFGF) in patients with tympanic membrane perforation (TMP). METHODS: The current study was a prospective, multicenter, open-label, single-arm, and exploratory clinical trial to evaluate the safety and efficacy of the TM regeneration procedure (TMRP). Myringotomy was used to mechanically disrupt the edge of the TMP, and a gelatin sponge immersed in bFGF was then placed over the perforation. Fibrin glue was dripped over the sponge as a sealant. TMP closure was examined 4 weeks later and, if insufficient, TMRP was repeated a maximum of three more times. TMP closure and hearing improvement 12 weeks after the final TMRP as well as safety were evaluated. RESULTS: Of the 11 patients with TMP who participated in this study, one who fulfilled the exclusion criteria and did not undergo TMRP and one with cholesteatoma were excluded from the efficacy analysis. TMP closure and hearing improvement 12 weeks after the final TMRP were achieved in eight out of nine patients (88.9%). Mean bone conduction threshold significantly improved 12 weeks after the TMRP compared with baseline (35.7±20.3 vs 29.4±21.0dB, P=0.015). Six out of ten patients receiving TMRP experienced temporary adverse events: appendicitis (serious, severe), otorrhea (mild), otitis media (mild), and sudden hearing loss (mild). However, none were related to the protocol treatment. CONCLUSION: TMP closure and hearing improvement were frequently confirmed following the TMRPs which were safely performed. These favorable outcomes were accompanied with significant improvement of the bone conduction threshold. These promising outcomes would encourage a large-scaled, randomized and pivotal clinical trial in the future. This trial is registered at http://www.umin.ac.jp/ctr/index.htm (identifier: UMIN000006585).

Improved tympanic membrane regeneration after myringoplastic surgery using an artificial biograft.

Tympanic membrane perforations are due to common otologic problems. The current treatments to heal tympanic membrane perforation, such as myringoplasty, have some disadvantages, including the need for autologous grafting, which is rapidly absorbed by the organism before perforation recovery is complete. To improve the structural and functional tympanic membrane healing after surgery, we propose a new branch of artificial grafts. In this study, we report the development of artificial grafts using electrospun bioabsorbable polymers. Polymers such as poly (l-lactic acid) and poly (lactic-co-glycolic acid) acted as the scaffold for cell growth in a co-culture of fibroblasts and keratinocytes. This co-culture promoted the growth of an epithelial-equivalent tissue over the electrospun scaffold, which was used as an alternative graft in myringoplasty. The in vivo study was performed in Sprague Dawley rats. Ear endoscopy was performed 30days after surgery and showed that tympanic membrane perforations treated with artificial grafts healed naturally, completely and with the possibility of maintaining their actual functionality. In conclusion, our study described a new artificial graft created specifically to fulfill the requirements of perforated tympanic membrane healing processes, which are compatibility, proper durability and less intense side effects following myringoplasty.

Tympanic membrane healing process and biocompatibility of an innovative absorbable ventilation tube.

OBJECTIVE: To investigate tympanic membrane healing process and biocompatibility of pressure-equalizing (PE) tubes, made of a novel biodegradable, absorbable material, in an animal model. BACKGROUND: Myringotomy and pressure-equalizing tube insertion is a frequent otologic procedure in children. However, results may vary because of the unpredictable extrusion rate of tubes. Furthermore, tubes that are no longer required need a surgical procedure to be removed. The ideal pressure-equalizing tube should remain in place for the time selected by the otologist, with no need for subsequent removal. This objective could be met with pressure-equalizing tubes made from a self-disintegrating material. METHODS: Pressure-equalizing tubes, made of poly-bis(ethylalanate)phosphazene, were inserted in 55 ears of 28 Hartley guinea pigs, with survival times of 10, 30, and 60 days after tube insertion. In vivo reactions between the poly-bis(ethylalanate)phosphazene pressure-equalizing tubes and the tympanic membrane were studied. Tympanic membranes, middle ears, and tubes were examined by scanning electron microscopy. RESULTS: There was neither infection nor inflammatory reaction to the tube in any animal. The healing process of tympanic membranes revealed neither residual perforation nor inward spread of skin epithelium into the middle ear cavity. At 30 days, 53% of the tubes had disintegrated. At 60 days, tubes were functioning in 25% of ears. CONCLUSION: These new poly-bis(ethylalanate)phosphazene pressure-equalizing tubes are promising. The healing process of tympanic membranes is excellent, with no complications. The tube disintegration rate can be controlled by varying the formulation of the polymer, obtaining tubes with predictable resorption rates, to adapt treatment to the needs of each single patient.

Alloplastic bone cements in otologic surgery: long-term follow-up and lessons learned.

OBJECTIVE: Otolaryngologists are often confronted with structural defects in the tegmen, scutum, or external auditory canal (EAC). Carbonated calcium phosphate (CCP) bone cements offer an alternative way of managing these defects. STUDY DESIGN AND SETTING: Retrospective review in an academic otology practice. The technical feasibility of these techniques described as well as the wound healing and structural integrity results. RESULTS: CCP bone cement was used to reconstruct defects of the tegmen or EAC in 22 patients. The material was used to repair the EAC in 19 of these patients, including complete EAC reconstruction in 4 patients, and tegmen defects only in 3 cases. CONCLUSION: The surgical technique is not technically difficult and the alloplastic material is hard within minutes of application. Twenty patients have been followed for over 1 year with an average follow-up period of 3.8 years. Failure, defined as infection or explantation, occurred in 4 patients followed over 3 years. There was a difference in outcomes for pediatric cases. EBM RATING: C-4.

Cross-linked hydrogels for middle ear packing.

OBJECTIVE: To develop an ideal supportive packing material for ossiculoplasty, tympanoplasty, or other otologic procedures. MATERIALS AND METHODS: Several materials, namely, Carbylan-SX (P-C; Sentrx Surgical, Inc., Salt Lake City, UT), Gelfoam (P-GF; Pharmacia & Upjohn, Kalamazoo, MI), and Merogel (P-MG; Medtronics, Inc., Minneapolis, MN), were prepared and then placed into a Hartley guinea pig's (Elm Hill, Chelmsford, MA) middle ear cavities through a large myringotomy incision. The contralateral ear underwent a large myringotomy without packing material being placed. Preoperative and posteroperative auditory brainstem response studies were performed using Intelligent Hearing system software. The animals were examined weekly. Two weeks after packing placement, the animals were killed, and the temporal bones were harvested. Whole temporal bone sectioning was performed to analyze the presence of implant, surrounding inflammation, presence of osteoneogenesis and fibrosis, or adhesions. RESULTS: All the materials, except the P-MG, were easy to place into the middle ear cavity. The P-MG contains woven strands that are difficult to trim into the small sizes needed for placement. The P-MG group had a smaller average amount of implant present compared with the other groups at 2 weeks. The degree of osteoneogenesis was similar among the P-GF, P-C, and P-MG groups. The P-MG and P-C groups contained the lowest amount of fibrosis between the implant and surrounding middle ear structures. CONCLUSION: This study demonstrates promising results with P-C as a potential supportive packing material for otologic procedures. P-C compares favorably with P-MG and P-GF in a guinea pig model with respect to ease of placement and amount of fibrosis.