|Year : 2022 | Volume
| Issue : 3 | Page : 383-387
Comparison conventional endoscopic myringoplasty with fibrin glue supplemented endoscopic myringoplasty
Rajendiran Devendiran1, Nagabooshanam Mohanbabu2, Venugopal Ravikumar3
1 Department of ENT, Government Villupuram Medical College, Villupuram, India
2 Department of ENT, Government Thiruvarur Medical College, Thiruvarur, India
3 Department of ENT, Government Medical College, Namakkal, Tamil Nadu, India
|Date of Submission||06-Aug-2022|
|Date of Acceptance||23-Aug-2022|
|Date of Web Publication||29-Sep-2022|
Dr. Rajendiran Devendiran
Department of ENT, Government Villupuram Medical College, Villupuram 605601, Tamil Nadu
Source of Support: None, Conflict of Interest: None
Introduction: The fibrin tissue glues have been used in many surgeries to reinforce surgical sutures and tissue adhesion. Myringoplasty is the commonly done ear surgery for the perforations of the tympanic membrane, where no suturing is done between remnant membrane and graft. Aim: The aim of the study is to compare the results and effectiveness of this biological fibrin tissue glue in myringoplasty surgeries as a supplementary procedure to conventional endoscopic myringoplasty (CEM) surgeries. Materials and Methods: Seventy patients with chronic suppurative otitis media with tympanic membrane perforation without ossicular and mastoid involvement have been chosen. One group of 35 patients underwent CEM surgeries. In another group of 35 patients, biological fibrin tissue glue, TISSEEL, has been used as supplementary to the CEM surgeries, and the graft uptake rate and hearing improvement were evaluated and compared postoperatively. Results: The graft success rate at 3 months postoperatively was 91.42% in both the groups, that is, 32/35, and these values were not statistically significantly different (P = 1.00). There was a highly statistically significant hearing outcome before and after the surgery in both the CEM and the fibrin tissue glue supplemented endoscopic myringoplasty groups. However, there was no statistically significant change in hearing outcomes between the two groups. Conclusion: In our study, we have got more or less similar results compared with the results of the studies on routine CEM cases. But the high-cost nature of the commercially available fibrin tissue glue makes it difficult to recommend for use in all routine endoscopy myringoplasty cases.
Keywords: Fibrin glue, fibrin tissue adhesive, tissue glue
|How to cite this article:|
Devendiran R, Mohanbabu N, Ravikumar V. Comparison conventional endoscopic myringoplasty with fibrin glue supplemented endoscopic myringoplasty. MGM J Med Sci 2022;9:383-7
|How to cite this URL:|
Devendiran R, Mohanbabu N, Ravikumar V. Comparison conventional endoscopic myringoplasty with fibrin glue supplemented endoscopic myringoplasty. MGM J Med Sci [serial online] 2022 [cited 2022 Nov 29];9:383-7. Available from: http://www.mgmjms.com/text.asp?2022/9/3/383/357488
| Introduction|| |
Myringoplasty, otherwise known as type 1 tympanoplasty, is the commonly done procedure for the closure of perforation of the tympanic membrane to improve hearing and prevent recurrent infections in chronic suppurative otitis media (CSOM)–tubotympanic type (TTD-mucosal type). Endoscopic myringoplasty is the method of choice in recent times because of the avoidance of ugly scars and better visualization of hidden areas of the middle ear with ultra-high-definition cameras and screens, compared with conventional microscopic myringoplasty (CEM). In this, the graft is placed under the freshened edges of the perforation without any suturing technique, which can lead to the displacement of the graft and the failure of the intended surgery. Practically, suturing the graft with remnant perforation in the narrow external auditory canal is impossible. So, there is a need to identify an alternate method of tissue adhesion in this surgery.
Adhesives have been used for wound closure to stabilize and fix tissues since ancient times. From long back, natural rubber and bee wax were used to cover the posttraumatic wound with good results. Secured fixation of skin grafts, implants, and transplants is of vital importance in minimally invasive surgery methods, especially in mucosal areas. Tissue glues are used as a method of choice in these surgeries. Homologous fibrin glues are the most utilized tissue adhesives since 1950.
Fibrin plays an essential role in wound healing. It induces cellular response to wounding damage by forming fibrin strands, which eventually build a matrix with hemostatic effects and assist in fibroblast proliferation and neovascularization. Tidrick and Warner first used fibrinogen and thrombin as tissue adhesives in otorhinolaryngological procedures. Staindl introduced the potential use of fibrin tissue adhesive in otorhinolaryngological surgeries. Since then, the use of fibrin sealant has been popular in both otological and neuro-otological procedures.,
In our study, we have attempted to compare the postoperative surgical and functional outcomes of the CEM surgeries and fibrin tissue glue (TISSEEL, a fibrin sealant from Baxter India Pvt. Ltd., Gurugram, Haryana, India) supplemented endoscopic myringoplasty (FEM) surgeries. The use of TISSEEL has been most widely reported in the literature.
Our study aims to compare the postoperative surgical and functional outcomes of CEM surgeries with FEM surgeries. The objectives of this study are:
- To compare the graft uptake percentage in both types of surgeries
- To compare the audiological improvement in hearing in both types of surgeries.
| Materials and methods|| |
Patients of age group 15–50 years, with CSOM-TTD with perforation (inactive stage—ear dry for minimum 1 month), with intact ossicular chain and without mastoid involvement, were included in our study. The following were excluded from the study:
- Age: <15 years and >50 years
- Patients with active stage of CSOM-TTD type
- Patients with ossicular chain damage and with mastoid air cells involvement
- Patients with bleeding and clotting disorders.
The study was approved by the Ethical Committee for Humans at Institutional Ethics Committee (CDSCO reg. no. ECR/1378/INST/TN/2020 and DHR reg. no. EC/NEW/INST/2020/636 as per the guidelines laid by CPCSEA). It was conducted following the principles of the Declaration of Helsinki. Informed written consent forms were obtained from all participants to undergo the study and also for their medical information to be used for scientific research.
This study was conducted in a Government Medical College Hospital from January 2021 to December 2021. Seventy patients (25 males and 45 females) with CSOM-TTD were included in our study after endoscopic evaluation. Preoperative puretone audiometry with air conduction threshold (ACT) of 500 Hz, 1000 Hz, and 2000 Hz and radiological evaluation with computerized tomography temporal bone were done to rule out the ossicular chain and mastoid involvement.
Those 70 patients were divided into two groups of 35 patients each: group 1—CEM group and group 2—FEM group. The single blinding technique was followed in this study.
All the study patients were undergone endoscopic myringoplasty by using temporalis muscle fascia graft as an underlay technique method after freshening the edges of the tympanic membrane and elevating the tympanomeatal flap. But, only in group 2 FEM patients, about 1 mL of biological fibrin tissue glue (TISSEEL, a fibrin sealant from BAXTER company) applied over the edges of the graft after the graft placement, at the end of the surgery. The external auditory canal was filled with gel foam in both group patients before dressing was done [Figure 1] and .
|Figures 1 and 2: Show the fibrin glue being applied to two different patients, at the end of their surgeries|
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All patients were given systemic antibiotics (levofloxacin or amoxicillin-clavulanic acid) for 5–7 days after surgery. They were instructed to avoid sneezing violently and nose pinching. In the first week after surgery, aural packs and the stitches of the graft harvested area were usually removed. The gelatine sponge fragments were cleaned to observe the location and activity of the graft. All patients were followed up at 1 week, 1 month, and 3 months after surgery. At the end of 3 months, all patients were evaluated with endoscopy for graft uptake and with puretone audiometry (ACT, air-bone gap [ABG] at frequencies of 500, 1000, and 2000 Hz) for hearing improvement.
Data were analyzed as graft uptake rate and as hearing improvement between pre- and postoperative hearing. Data were analyzed using the Fisher exact test, the chi-squared test, and the dependent and independent t-test in IBM SPSS Statistics for Windows, version 23.0 (IBM Corp., Armonk, NY, USA). The level of statistical significance was set at P < 0.05.
| Results|| |
Grafting success was defined as the presence of an intact tympanic membrane without perforation, which was evaluated by a 0-degree endoscope, 3 months after surgery [Table 1]. The graft success rate at 3 months postoperatively was 91.42% in both the CEM and FEM groups, that is, 32/35, and three patients from both the groups had residual/remnant tympanic membrane perforation. These values were not statistically significantly different (P = 1.00) [Figures 3] and .
|Table 1: Graft uptake success rate comparison between conventional endoscopic myringoplasty and fibrin glue supplemented endoscopic myringoplasty groups|
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|Figures 3 and 4: Show the graft taken-up statues in the same patients as those mentioned in Figures 1 and 2|
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Both groups were compared in their functional outcomes of improved hearing by comparing the average of pre- and postoperative ACTs and ABG value between these groups.
Preoperative mean ACT of CEM cases was reduced from 43.17 dB to 32.67 dB in the postoperative period of 3 months. Preoperative mean ACT of FEM cases was reduced from 44.96 dB to 33.28 dB in the postoperative period of 3 months.
Preoperative mean ABG, of CEM cases, was reduced from 29.41 dB to 20.60 dB in the postoperative period of 3 months. Preoperative mean ABG, of FEM cases, was reduced from 29.05 dB to 19.06 dB in the postoperative period of 3 months.
Hearing outcomes were as shown in [Tables 2] and . There was a highly statistically significant hearing outcome before and after the surgery in both the CEM and FEM groups. However, there was no statistically significant change in hearing outcomes between the two groups. Thus, the hearing outcome did not change with the use of biological fibrin glue.
|Table 2: Comparison of improvement in postoperative air conduction threshold in conventional endoscopic myringoplasty and fibrin glue supplemented endoscopic myringoplasty groups|
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|Table 3: Comparison of improvement in the postoperative air-bone gap in conventional endoscopic myringoplasty and fibrin glue supplemented endoscopic myringoplasty groups|
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| Discussion|| |
The presence of a tympanic membrane perforation in CSOM-TTD makes a person hearing impaired, and the degree of hearing loss depends upon the size of the perforation. Also, the entry of infecting microorganisms through the perforation may lead to the activation of quiescent CSOM disease. Endoscopic repair of the tympanic membrane perforation by using temporalis muscle fascia graft is the most commonly performed procedure in otology in low economic populations. But, there is no fixation of graft in the recipient site in that procedure. For this issue, a new method of fixation by using biological fibrin tissue glue from human pooled plasma is being attempted.
The thrombin and fibrinogen, in fibrin tissue glue, form crosslinked fibrin as that of the final stage of blood coagulation. The concentration of fibrinogen in this fibrin tissue glue is 15–25 times higher than in circulating blood plasma. Therefore, fibrin is formed much earlier. The other main component is factor XIII, which forms an indissoluble fibrin matrix. Also, fibrin glues have antifibrinolytic substances (aprotinin tranexamic acid) for stabilizing the adhesion by preventing fibrinolysis.
Fibrin deposits are degraded either by proteolytic enzymes produced by inflammatory cells or by phagocytosis by macrophages. The time duration of biodegradation depends on the amount of fibrinogen and aprotinin used and the site of application (mostly 1–9 weeks).
Advantages of fibrin glue are: (1) no heat formation during sealing, (2) good adhesion in wet conditions, (3) degradation without major tissue reaction in a few days, and (4) faster curing time (30 s).
Their disadvantages are: (1) adhesion is stress-liable, (2) not strong adhesive strength, (3) risk of transmission of blood-borne pathogens, as derived from blood products, (4) allergic reactions due to aprotinin content derived from bovine, and (5) highly expensive. Fibrin glue should not be used in the arterial or heavy venous bleeding site.
Yuasa and Yuasa in their study of underlay myringoplasty with fibrin glue for the repair of tympanic membrane perforation reported a success rate of 97.3%. A study conducted by Kaushik and Jain in 2017 had a success rate of 90% in 60 cases of chronic otitis media repaired using tissue glue. Bansal et al. reported the reduction of ABG from 33.4 dB to 24 dB by using autologous fibrin glue. Sakagami et al. report a success rate of 78% in underlay myringoplasty with fascia with fibrin glue in 391 ear surgeries.
In our study, we have a 91.42% success rate in graft uptake, an average 11 dB improvement in ACT, average 10 dB reduction in ABG in the patients treated with fibrin glue.
The strengths of our study are: (1) the method of using tissue glue is very simple, (2) biological tissue glue is being used, (3) both surgical and functional outcomes are measured and compared. The major limitation of our study is that the cost of fibrin glue is very high, which may be a reason for the minimal number of research studies on this topic. We too have restricted the number of sample cases considering the cost of the glue. Further studies with a large number of cases may bring more evidence for the usage of fibrin glue.
| Conclusion|| |
Adhesion between the graft and remnant tympanic membrane is the most crucial factor, which decides the success of the myringoplasty surgery. There are so many factors that can displace the correctly placed graft and the failure of surgical outcome. Unfortunately, the best surgical adhesion, suturing, cannot be done in the very narrow external auditory canal. The alternative solution to this issue, in the present scenario, is the usage of tissue glue. Clinical studies on this topic are rarely done to date. Therefore, we have attempted to study the outcomes of FEM cases. In our study, we did not get a statistically significant graft uptake success rate or hearing outcome improvement by using tissue glue, compared with the results of the studies on routine endoscopic myringoplasty cases. So the high-cost nature of the commercially available fibrin tissue glues makes it difficult to recommend for use in all routine endoscopy myringoplasty cases.
The Institutional Ethics Committee of Government Villupuram Medical College, Villupuram 605601, Tamil Nadu, India, has approved the study protocol vide letter no. GVMC/IEC/2020/46, dated 12 August 2020.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2], [Table 3]