Article
To read the full-text of this research, you can request a copy directly from the authors.

Abstract

OBJECTIVE: To evaluate the use of porcine small intestinal submucosal grafts for tympanic membrane repair. PATIENTS: Adult and pediatric patients with tympanic membrane perforations with and without chronic otitits media, and perforations after removal of cholesteatoma. INTERVENTION: Endoscopic or microscopic tympanic membrane repair using porcine small intestinal submucosal grafts (Biodesign). MAIN OUTCOME MEASURE(S): Perforation closure, bone and air pure-tone averages (PTA), air-bone gap (ABG), and word recognition scores (WRS) were recorded as outcome measures. RESULTS: Thirty-seven patients were included with a mean age of 25.4 years (range, 6-75), 57% men. Twenty-six cases (70%) were performed endoscopically and 34 (92%) had concomitant cartilage grafting. Three patients (8%) had postoperative pinpoint (<1% surface area) perforation, and two patients (5%) had postoperative perforation, with an overall success rate of 86.5%. The mean improvement in air-bone gap was 7.6 dB and (p = 0.006). There were no statistically significant differences in closure rates when comparing primary versus revision cases, endoscopic versus microscopic cases, size of perforation, cholesteatoma, concomitant mastoidectomy, age, tobacco exposure, or comorbid diabetes mellitus. Patients with concomitant cartilage graft were more likely to be successful when compared with those without cartilage graft (p = 0.04). CONCLUSIONS: Porcine small intestinal submucosal grafts are effective in the repair of the tympanic membrane. These grafts are an excellent choice in total endoscopic cases as it avoids incisions necessary for allograft harvest.

No full-text available

Request Full-text Paper PDF

To read the full-text of this research,
you can request a copy directly from the authors.

Article
Background Transcanal totally endoscopic ear surgery (TEES) has become increasingly popular internationally; however, for surgeons trained with a two-handed microscope-guided approach, the potential challenges of adopting TEES can appear off-putting.Objectives This article outlines the pros and cons of TEES for tympanic membrane repair and describes aspects of surgical technique relevant to those who might adopt this approach.Materials and methodsData are provided from the author’s experience along with a review of relevant literature, including several meta-analyses of tympanoplasty outcome.ResultsMeta-analyses show that TEES tympanoplasty is as effective at closing tympanic membrane perforations and improving hearing as microscope-guided surgery. Yet patients benefit from avoidance of a skin incision and faster recovery.Conclusion Repair of the tympanic membrane with TEES is feasible and effective. This minimally invasive approach is very appealing to patients.
Article
Objective To compare the use of porcine small intestinal submucosal grafts (SISG) and standard autologous material (fascia) in prevention of cerebrospinal fluid (CSF) leak and pseudomeningocele formation after translabyrinthine resection. Setting Set at the tertiary skull base center. Methods This is a retrospective chart review. After Institutional Review Board approval, we performed a retrospective cohort study evaluating CSF leak in patients who underwent resection of lateral skull base defects with multilayered reconstruction using either fascia autograft or porcine SISGs. Demographics were summarized with descriptive statistics. Logistic regression was used to compare autograft and xenograft cohorts in terms of CSF complications. Results Seventy-seven patients underwent lateral skull base resection, followed by reconstruction of the posterior cranial fossa. Of these patients, 21 (27.3%) underwent multilayer repair using SISG xenograft. There were no significant differences in leak-associated complications between autograft and xenograft cohorts. Ventriculoperitoneal shunt was necessary in one (1.8%) autograft and one (4.8) xenograft cases (p = 0.49). Operative repair to revise surgical defect was necessary in three (5.4%) autograft cases and none in xenograft cases. Conclusion The use of SISG as a component of complex skull base reconstruction after translabyrinthine tumor resection may help reduce CSF leak rates and need for further intervention.
Article
Objective: To compare outcomes and complications of endoscopic lateral graft (LGT) and interlay (IT) tympanoplasty. Study design: Prospective observational cohort study of totally endoscopic ear surgery (TEES) tympanoplasty. Setting: Pediatric tertiary referral center. Patients: One hundred fourteen surgeries for children with tympanic membrane perforation without cholesteatoma. Intervention: Porcine-derived collagen graft tympanoplasty using either LGT or IT. Main outcome measures: Closure rates of perforation, hearing outcomes (four-tone average air conduction [AC] and air bone gap), and complications that required further surgery were assessed 12 months postoperatively. Results: Perforation closure rates did not differ between LGT (52/59 (88%)) and IT (45/51 (88%)), (Fisher's exact p = 1.00) (four ears lost to follow-up). AC thresholds (p = 0.32) and air bone gap (p = 0.88) improved similarly after surgery with LGT (median 8.8 dB) and IT (median 7.5 dB). The proportion of ears with serviceably normal hearing (AC ≤ 30 dB HL) postoperatively was similar (LGT 40/49 (82%), IT 36/46 (78%), Fisher's exact p = 0.80). Following IT, three (6%) ears developed inclusion cholesteatoma requiring revision surgery. One (2%) LGT ear developed blunting after myringitis. Conclusions: IT and LGT provide similar perforation closure rates and hearing outcomes. When choosing between these two techniques to repair pediatric tympanic membrane perforations, LGT would seem to be preferable than IT due to the risk of inclusion cholesteatoma after IT. There is a small risk of anterior blunting after LGT.
Article
Herein we provide a broad overview of the literature as it applies to endoscopic myringoplasty and type I tympanoplasty. Advantages and disadvantages of the endoscopic approach are reviewed for both the adult and pediatric populations and are compared with conventional microscopic techniques.
Article
This study reports 6‐month follow‐up hearing results and graft take rate of 72 patients diagnosed with simple chronic otitis media receiving transcanal endoscopic tympanoplasty with porcine small intestine submucosa (SIS) xenograft (Biodesign). This xerograft eliminates donor site morbidity and reduces the operation time of graft harvesting. Hence, SIS provides a relatively convenient and time‐saving method to pursue a tissue graft for perforations repair. Results showed an overall success rate of 94.7% for perforation closure. SIS graft take rate was comparable to that of allografts (such as temporalis fascia and cartilage). In addition, there were significant postoperative improvements in air‐conduction threshold and air‐bone gap at 0.5–4 kHz. No recipient experienced immune reactions in this study. All except four tympanic membrane perforations completely healed within 3 months postoperatively. Exclusive transcanal endoscopic tympanoplasty with porcine SIS represents a good choice for tympanic membrane perforation repair. Moreover, it provides good hearing results.
Article
Background: Acellular dermal allograft (AlloDerm) and cartilage perichondrium are two common materials used for repair of tympanic membrane perforations (TMPs). To date, comparative evaluations of their efficacy have rarely been reported. Aim/objectives: To compare anatomical and audiological outcomes between AlloDerm and cartilage perichondrium in type I tympanoplasty. Methods: A total of 61 patients of TMP were studied. In total, 27 patients (Group 1) underwent AlloDerm myringoplasty, and the remaining 34 patients (Group 2) underwent perichondrium myringoplasty. Operating time, closure rate and hearing gain were compared between Groups 1 and 2. Results: Successful closure rates at 6-month follow-up were 88.9% (Group 1) and 82.4% (group 2). The average improvement of air-bone gap (ABG) was 13.5 ± 11.8 dB for Group 1 and 13.1 ± 13.1 dB for Group 2. The difference in between preoperative and 6 months postoperative ABG values was statistically significant (p < .001). Conclusions and significance: Success rates and improvement of hearing level were similar for the AlloDerm (Group 1) and the cartilage perichondrium (Group 2) groups. However, AlloDerm requires shorter operative time and avoids the incisions in the harvest of allografts. Our results suggest that AlloDerm can be recommended as an attractive alternative to cartilage grafts.
Article
Over the last decades, small intestinal submucosa (SIS), a naturally occurring decellularized extracellular matrix (ECM), has attracted much attention in tissue repair because it can provide plentiful bioactive factors and biomimetic three-dimension microenvironment to induce desired cellular functions. In this article, the state-of-the-art researches on SIS are reviewed, which are mainly centered on three aspects: (1) main superiority such as remarkable bioactivity, low immunogenicity, satisfactory resorbability and promising recellularization; (2) current efforts to overcome its limitations mainly focusing on reducing the natural occurring heterogeneity, controlling degradation rate and improving mechanical property; (3) great potential in solving the bottleneck problems encountered in repair of various tissues with particular emphasis on cardiovascular, urogenital, abdominal wall, skin, musculotendinous, gastrointestinal, vagina, bone. In addition, future research trends are proposed in the conclusion and perspectives part.
Article
Full-text available
Most chronic tympanic membrane (TM) perforations require surgical interventions such as tympanoplasty because, unlike with acute perforations, it is impossible for the perforations to heal spontaneously. The purpose of this study was to develop novel therapeutic techniques and scaffolds that release growth factors to treat chronic TM perforations. We evaluated the cell proliferation effects of epidermal growth factor (EGF) and fibroblast growth factor (FGF) on in vitro cultures of TM cells using an MTT assay. They both showed similar efficacy, so we used EGF because of its lower cost. We then constructed an EGF-releasing-chitosan patch scaffold (EGF-CPS) based on previous studies. We analyzed its toxicity and strength, and we studied it using scanning electron microscopy. EGF was released from the EGF-CPS for 8 weeks in an in vitro system. In animal studies, the EGF group, which was treated with EGF-CPS, showed healing in56.5% of the animals (13/23), while the control group, which did not receive any treatment, revealed 20.8% healing (4/24) (p=0.04). Transmission electron microscopic studies of regenerated eardrums in the EGF group showed much greater preservation of histological features, and TMs of EGF group were thinner than spontaneously healed TMs. In conclusion, this novel EGF-CPS can be used as a nonsurgical intervention technique for treatment of chronic TM perforations.
Article
Objective: To compare the efficacy of three different myringoplasty techniques, namely hyaluronic acid fat graft myringoplasty (HAFGM), fat graft myringoplasty (FGM), and temporal fascia for the closure of different sizes and sites of tympanic membrane perforations. Materials and methods: We retrospectively analyzed the medical records of patients who had undergone a type 1 tympanoplasty operation at our clinic between May 2007 and February 2013. The patients were divided into three groups depending on the patient's choice of technique as follows: Fat Graft Myringoplasty (FGM) (Group I), Hyaluronic Acid Fat Graft Myringoplasty (HAFGM) (Group II), and Temporalis Fascia (TF) (Group III). A total of 136 patients were included in the study, split in to the FGM (57 patients; 56.1% female; median age: 30 years), HAFGM (31 patients; 54.8 female; median age: 25 years), and TF (48 patients; 58.3% females; median age: 33 years) surgery technique groups. Results: The patients were further divided into two groups, depending on the size of the perforation (small and large), and into three groups, depending on its location (anterior, inferior, and central). None of techniques provided a significantly better success rate in terms of perforation location (p>0.05). Also, none of the techniques provided a significantly better success rate in terms of perforation size (p>0.05). Conclusion: We propose using HAFGM for large perforations and FGM alone for small perforations. The TF technique is a successful and well-defined technique for tympanic membrane perforations; however, in our opinion, its technical difficulties make it a secondary choice, particularly for small-sized perforations.
Article
Objective: A pilot study was performed to investigate the utility of basic fibroblast growth factor (bFGF) in the repair of blast-induced total or near-total tympanic membrane perforations (TMPs). Study design: Prospective clinical study. Setting: Tertiary university hospital. Subjects and methods: Patients who fulfilled the inclusion criteria were treated with 0.10-0.15 mL of bFGF solution applied directly to total or near-total TMPs once daily until the perforations closed or for a maximum of 6 months. The treatment response was monitored via serial otoendoscopy, and audiometric outcomes were evaluated. Results: Complete TMP closure was achieved in 16 of 17 patients with a blast-induced total or near-total TMP. The mean closure time was 28.4 ± 10.9 days. The improvement in hearing from pre- to post-treatment was statistically significant. There were no complications or adverse outcomes. Conclusions: The direct application of bFGF to blast-induced total or near-total TMPs is a promising, minimally invasive alternative to conventional tympanoplasty, with a comparable success rate. As reported in the literature, the closure rate was higher than achieved with spontaneous healing. There was no effect of the inverted edge on healing outcome. The use of bFGF in this setting has immediate therapeutic applications for military personnel with blast-induced TMPs who are stationed in isolated, remote environments.
Article
A novel bioactive material for tissue graft, derived from porcine small intestinal mucosa (SIS) has been marketed. This material promotes early vessel growth, provides scaffolding for the remodeling tissues, and is inexpensive and ready-to-use. We evaluated efficacy, safety, and surgery time of SIS myringoplasty, in comparison with autologous temporalis fascia (PTF) repair in children in a prospective, two-group (SIS and PTF) randomized, blinded study at a tertiary-care pediatric institution. 404 children with tympanic membrane (TM) repair were randomly assigned to receive SIS or PTF myringoplasty. Primary outcome was the healing of the TM at 6 months. Secondary outcomes were surgical time, and adverse events. Long-term follow-up ranging from 11 to 2 years was obtained in all enrolled children. Audiometric tests as pure-tone thresholds were applied in all patients. The Fisher's exact test and the Kriskal-Wallis test were applied for statistical analysis. Four-hundred-thirty-two TM perforations were treated, 217 in the SIS and 215 in the PTF groups. There were 209 stable TM closures in the SIS (96.3%) and 204 (94.8%) in the PTF arm. This difference was not statistically significant (odds ratio=0.4, 95%; confidence interval=0.12-1.41). SIS myringoplasty yielded reduced surgical time. No adverse reaction to SIS was encountered. Audiometric tests revealed no statistically significant difference in the two groups. SIS myringoplasty is a safe and effective method for TM closure in children with reduced surgical time, as compared to PTF. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.
Article
Objective: We wished to determine if the success of lateral graft tympanoplasty was affected by either size of perforation, previous underlay tympanoplasty, or patient age. Patients: A review was performed of patients who underwent lateral graft tympanoplasty by the senior author between March 2010 and July 2013 with patient number based on an a priori power analysis. Patient demographics, baseline clinical data, postoperative findings, and audiologic data were collected. Interventions: Lateral graft tympanoplasty. Main Outcome Measures: The primary outcome was closure of perforation. The secondary outcome was change in air-bone gap. Results: Thirty patients were included with a mean follow-up period of 14 months. Closure of tympanic membrane perforation occurred in 93%. Closure was observed in 13 of 15 (87%) patients with perforations 50% or smaller and in all patients (15 of 15) with perforations larger than 50% (p = 0.48, Fisher’s exact test). For revision cases, 8 of 9 (89%) were closed compared to 20 of 21 (95%) in primary tympanoplasty (p = 0.52). Perforations in adults and children were equally likely to be closed (10 of 11 children vs. 18 of 19 adults) (p = 1). The mean preoperative to postoperative air-bone gap improved from 24 ± 12 dB to 14 ± 8 dB (p = 0.0003, paired t test). Conclusions: Lateral graft tympanoplasty has a high success rate for the closure of tympanic membrane perforations with a significant improvement in air-bone gap. There were no significant differences in success comparing small versus large perforations, primary versus revision tympanoplasty, or adults versus children.
Article
Objective: The lateral-to-malleus underlay tympanoplasty (LMUT) involves dissection of the tympanic membrane remnant from the malleus with subsequent graft placement medial to the annulus but lateral to the malleus. The objective of the current study is to describe the clinical outcomes using the LMUT technique. Patients: One hundred forty-one ears undergoing LMUT. To isolate the effects of tympanoplasty on audiometric outcome, only cases with an intact and mobile ossicular chain were evaluated; ears with ossicular discontinuity, fixation, and/or ossicular chain reconstruction were excluded. Intervention: Lateral-to-malleus underlay tympanoplasty. Main Outcome Measures: 1) Change in air-bone gap and bone conduction thresholds; 2) tympanic membrane lateralization; and 3) primary and delayed graft failure. Results: One hundred forty-one tympanoplasties were analyzed. In the early postoperative period, 140 (99%) of 141 grafts were intact and, at a mean of 32.1 months, 121 (85.8%) remained without significant retraction or reperforation. There were no cases of early or delayed graft lateralization. The mean preoperative and most recent postoperative air-bone gaps were 23.7 dB and 14.1 dB, respectively (p < 0.001). Surgery was not associated with a transient or long-term bone conduction threshold shift. Conclusion: The LMUT technique offers improved exposure of the tympanic space and a low rate of graft failure. The risks of sensorineural hearing loss with ossicular chain manipulation and tympanic membrane lateralization from graft placement lateral to the malleus are very low.
Article
Small intestinal submucosa (SIS) is a resorbable biomaterial that induces tissue remodeling when used as a xenogeneic tissue graft in animal models of vascular, urologic, dermatologic, neurologic, and orthopedic injury. Determination of the composition and structure of naturally occurring biomaterials such as SIS that promote tissue remodeling is necessary for the greater understanding of their role in wound healing. Since glycosaminoglycans (GAGs) are important components of extracellular matrix (ECM) and SIS is primarily an ECM-based material, studies were performed to identify the species of glycosaminoglycans present in SIS. Porcine SIS was chemically extracted and the extracts were analyzed for uronic acid. The extractable uronic acid content was determined to be 47.7 micromol/g (approximately 21 microg GAG/mg) of the dry weight of the SIS tissue. Using electrophoretic separation of GAGs on cellulose acetate membranes, hyaluronic acid, heparin, heparan sulfate, chondroitin sulfate A, and dermatan sulfate were identified. Digestion of specific GAGs with selective enzymes confirmed the presence of these GAG species. Two GAGs common to other tissues with large basement membrane ECM components, keratan sulfate and chondroitin sulfate C, were not detected in the SIS extracts. Identification of specific GAGs in the composition of the ECM-rich SIS provides a starting point toward a more comprehensive understanding of the structure and function of this naturally occurring biomaterial with favorable in vivo tissue remodeling properties.
Article
Objective: To describe and evaluate the medio-lateral graft tympanoplasty(1) for the reconstruction of anterior or subtotal tympanic membrane (TM) perforation and medial graft tympanoplasty for posterior TM perforation. Methods: Retrospective study of 200 patients who underwent medio-lateral graft tympanoplasty (100 cases) and medial graft tympanoplasty (100 cases) at community and tertiary care medical centers from 1995 to 2006. All patients underwent preoperative and postoperative audiograms. In the medial graft tympanoplasty, the graft is placed entirely medial to the remaining TM and malleus. First, margin of TM perforation is denuded removing ring of squamous tissue. Tympanomeatal flap is elevated. Temporalis fascia is harvested, semidried, and grafted medial to the TM perforation and malleus with Gelfoam packing supporting the graft. In the medio-lateral graft technique, posterior tympanomeatal flap is elevated same as in the medial graft tympanoplasty first. Anterior-medial canal skin is elevated down to the annulus. At the annulus only squamous epithelial layer of TM is elevated up to anterior half of the TM perforation. Temporalis fascia is grafted medial to posterior half of the perforation and lateral to anterior half of the de-epithelialized TM perforation up to the annulus. Anterior canal skin is rotated to cover the fascia graft and TM perforation as a second layer closure. Patients were followed for at least six months. Outcome was considered successful if TM is healed and intact. Results: There were four failures (96% success rate) in medial graft method for posterior TM perforation due to infection and re-perforation. In the medio-lateral graft tympanoplasty, there were three failures (97% success rate) due to a postoperative infection, anterior blunting and recurrent cholesteatoma. Conclusion: The medial graft tympanoplasty works well for posterior TM perforation. The medio-lateral graft method is an excellent method for the reconstruction of large anterior or subtotal TM perforation. This new method should help otologic surgeons to improve outcome of tympanoplasty for anterior or subtotal TM perforation.
Article
The growth pattern of human epidermal cells, fibroblasts or Swiss mouse 3T3/J2 fibroblasts cultured upon the extracellular matrix (ECM) derived from small intestinal submucosa (SIS) was evaluated. The cell/SIS composites were grown submerged, then maintained in air/liquid interface for 2, 7, 10 or 14 days. The presence of differentiation-related keratins 10, 14 and 16, FN, laminin, collagen type VII and collagen type IV was determined by immunohistochemical methods in SIS alone and in the SIS/cell composite. Only FN could be detected in SIS alone. SIS supported the formation of an epithelial structure with suprabasal expression of K16 and regional suprabasal expression of K10. The epidermal cells were K14 positive and tended to 'invade' the SIS to various degrees. Following the growth of epidermal cells and fibroblasts on the SIS substratum, immunolabeling of FN, laminin, collagen type VII and collagen type IV was observed in a cell-associated pattern. The fibroblasts commonly invaded the SIS, when co-cultivated with epidermal cells on the opposite side of the SIS. The ability of SIS to support epidermal cell/fibroblast attachment, migration and/or proliferation and differentiation with deposition of basement membrane (BM) components indicates that the composite model may be useful for studying cell-matrix interactions and for investigation as a dermal substitute.
Article
To evaluate the efficacy of acellular porcine small intestine submucosa in the repair of chronic tympanic membrane perforations. Although tympanoplasty with autologous temporalis fascia and cartilage is common practice in the repair of chronic tympanic membrane perforations, these materials are associated with increased operative time and have variable availability and quality in individual patients. Recently, new materials for tympanoplasty have been explored, including acellular human dermis. Small intestine submucosa (Surgisis) is an inexpensive and readily available alternative to autologous and cadaveric grafts. In this study, we examined the use of small intestine submucosa in the repair of chronic tympanic membrane perforations in a chinchilla model. Prospective pilot study using 10 adult chinchillas. Chronic tympanic membrane perforations were created in 10 adult chinchillas for a total of 20 perforations. Each animal underwent observation in one ear and repair with either autologous cartilage or small intestine submucosa in the opposite ear with Type I tympanoplasty. A total of 20 chronic membrane perforations were created, with zero healing spontaneously after 8 weeks. In tympanoplasties performed in five chinchillas with small intestine submucosa, five of five (100%) remained healed 6 weeks postoperatively, whereas three of five (60%) remained healed with cartilage repair. Histologic analysis was performed in both successful cartilage and small intestine submucosa repairs. These results suggest that small intestine submucosa is a viable alternative to autologous and cadaveric grafts in tympanoplasty. A larger randomized study in humans is indicated to evaluate this material in clinical practice.
Reconstruction of the tympanic membrane is a common procedure in otology today. Many different materials have been used for this purpose, including a wide array of autologous tissues. This article focuses on the use of human acellular allograft dermal matrix (AlloDerm, LifeCell Corporation, Branchburg, New Jersey) in tympanoplasty. The choice of graft materials has expanded to include human dermal allograft tissue. Recent reports show promising results for AlloDerm reconstruction of the tympanic membrane, including animal experiments and in humans. AlloDerm has become an acceptable alternative to the use of autologous tissues in tympanic membrane surgery, particularly in type I tympanoplasty. This paper discusses the recent literature on the topic, outlines the authors' experience with the use of AlloDerm, and describes the authors' operative technique.
Article
To evaluate the success rate of subcutaneous postsurgical scar tissue as graft material for revision tympanoplasty operations. Retrospective case review. Tertiary referral center. Thirty-five patients who underwent revision tympanoplasty with or without mastoidectomy procedures and 36 patients undergoing primary operations who had all the data necessary for the study and a minimum follow-up of 6 months. The mean follow-up period was 12 months (range, 6-18 mo). Mean age, perforation size, cholesteatoma presence, time required for harvesting, and adjunctive mastoidectomies were similar between the two groups. The patients undergoing revision tympanoplasty had graft material harvested from the subcutaneous scar tissue. In the control group, temporalis fascia graft was used as graft tissue. The rate of perforation closure and postoperative hearing change was measured. In the scar tissue tympanoplasty group, 32 of 35 patients (91%) had successful closure of the tympanic membrane perforation, whereas in the control group, the success rate was 92% (p > 0.05). Mean postoperative pure-tone average improvement was 21 dB in the scar tissue tympanoplasty group and 18 dB in the control group (p > 0.05). Subcutaneous scar tissue is as successful in perforation closure and hearing improvement as temporalis fascia graft. The use of subcutaneous scar tissue graft is advantageous to other graft materials used in revision tympanoplasty operations in that it can be harvested through the same incision, does not add to the operative time, and does not carry the cost or risk of acellular dermis.