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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 26  |  Issue : 4  |  Page : 227-231

Role of in house tissue glue in tympanoplasty


1 Department of ENT, Satya Pal Wahi ONGC Hospital, Dehradun, Uttarakhand, India
2 Department of ENT, MAX Hospital, Dehradun, Uttarakhand, India
3 Department of ENT, SMIH, Dehradun, Uttarakhand, India
4 Department of ENT, Vikram ENT Hospital, Coimbatore, Tamil Nadu, India
5 Department of ENT, Gian Sagar Medical College, Patiala, Punjab, India

Date of Submission22-Aug-2020
Date of Decision02-Oct-2020
Date of Acceptance09-Oct-2020
Date of Web Publication23-Apr-2021

Correspondence Address:
Dr. Chetan Bansal
Department of ENT, Satya Pal Wahi ONGC Hospital, Dehradun, Uttarakhand
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/indianjotol.INDIANJOTOL_186_20

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  Abstract 


Introduction: Tympanoplasty is one of the commonly performed surgical treatments for chronic otitis media (COM). Graft used in tympanoplasty is temporalis fascia which is placed at the perforation site but usually without any securing agent like sutures, etc., This can lead to various problems such as medialization or lateralization of the graft (graft displacement) or anterior blunting, which affects the hearing outcome of tympanoplasty. Aim: The aim of this study is to study the role of in house autologous tissue glue in tympanoplasty as a graft-securing agent. Materials and Methods: One hundred cases of COM were divided into two groups of fifty cases each. In Group I, tympanoplasty was done without using tissue glue, whereas in Group II, tympanoplasty was done using in house autologous tissue glue as the graft securing agent, and the results were analyzed. Results: Graft uptake rate in Group I was 84% and in Group II was 92%. Five cases of anterior blunting and three cases of graft medialization were recorded in Group I, whereas there was only one case of anterior blunting in Group II with no graft displacement. Conclusion: Autologous in house tissue glue can be used as a graft-securing agent in tympanoplasty.

Keywords: Chronic suppurative otitis media, fibrin glue, perforation, temporalis fascia, tissue glue, tympanoplasty Introduction


How to cite this article:
Bansal C, Singh V P, Varma A, Anthwal P, Kanwar T. Role of in house tissue glue in tympanoplasty. Indian J Otol 2020;26:227-31

How to cite this URL:
Bansal C, Singh V P, Varma A, Anthwal P, Kanwar T. Role of in house tissue glue in tympanoplasty. Indian J Otol [serial online] 2020 [cited 2021 Jun 16];26:227-31. Available from: https://www.indianjotol.org/text.asp?2020/26/4/227/314345




  Introduction Top


Tympanoplasty is a common surgical procedure performed in cases of chronic otitis media (COM) for the repair of tympanic membrane perforations.[1] Many types of grafts have been used with various techniques with varied results. The most common and consistent graft material is temporalis fascia. This graft is placed through underlay, overlay, or interlay technique in tympanoplasty where it lies unsecured and is held loosely with the flap or abgel.[2] No sutures and staples, etc., are used to secure the graft, thus leading to failure of tympanoplasty with residual perforation requiring revision surgery, which is an added burden on the patient. Moreover, in successful cases, there can be anterior blunting, or the graft can be displaced either medially or laterally resulting in poor hearing outcome.[3]

Thus, an attempt has been made in this study to find a way to improve the graft uptake rate of tympanoplasty by using autologous tissue glue to secure the temporalis graft and to do a comparative study on the role of in house autologous sterile tissue glue in tympanoplasty.[3]


  Materials and Methods Top


One hundred cases of COM inactive mucosal type presenting to ear, nose, and throat outpatient department from July 2017 to July 2018 were included in this study. They were divided into two groups of fifty cases each.

Inclusion criteria

  • Patients having COM – Mucosal disease inactive
  • Patients having a central perforation in pars tensa
  • Patients having a dry ear for a period of 4 weeks
  • An air-bone gap below 40 dB
  • Age group (15–60 years).


Exclusion criteria

  1. COM – Active mucosal disease
  2. COM-squamosal disease (unsafe)
  3. Air bone gap above 40 dB
  4. Sensorineural and mixed hearing loss
  5. Patients with previously operated ear
  6. Patients with comorbid conditions (diabetes mellitus and hypertension) or patients on prolonged medications (steroids and cardiac medications).


In Group I, there were fifty cases in which tympanoplasty was done without using tissue glue. Patients (fulfilling the inclusion criteria) from July 2017 to December 2017 were included in the study.

In Group II, there were fifty cases in which tympanoplasty was done using autologous tissue glue. Patients (fulfilling the inclusion criteria) from January 2018 to July 2018 were included in this group.

All the cases were subjected to a detailed clinical workup. Relevant history and clinical examination was documented. Hearing was evaluated by pure-tone audiometry (PTA) at frequencies of 500, 1000, 2000, and 4000 Hz.

All the patients underwent Type 1 tympanoplasty using temporalis fascia graft through underlay technique under general anesthesia. All the surgeries for Group I and II were performed by the same surgeon using the same surgical technique except the use of autologous tissue glue in Group II cases. Conventional inlay/underlay technique of tympanoplasty was used in all 100 cases. However, in Group II, in house prepared tissue glue was used for graft anchoring [Figure 6]. Tissue glue was applied over the freshened margins of the perforation, and then, an Ab gel/Gel foam soaked in tissue glue was kept over the edges after graft placement. All the patients at the time of discharge were instructed to take adequate precautions to prevent the contact of water with the ear. Follow-up was done after 1 month and 3 months. A repeat PTA was done at the end of 3 months to assess the hearing improvement and otoendoscopy to assess the graft uptake.

Institutional ethics committee clearance

The present study was done as per the clearance and guidelines of our Institutional Ethics Committee vide letter no SGRR/IEC/01/18.


  Results Top


Preparation of Fibrin Glue

Fibrinogen

  • Step 1: Ten milliliter of patient's venous blood was withdrawn and centrifuged at a speed of 3000 rpm
  • Step 2: The supernatant fluid was then collected as plasma and stored at 20°C.[4]


Thrombin

  • Step 1: Fresh-frozen plasma was obtained from the blood transfusion unit
  • Step 2: Ten milliliter of fresh-frozen plasma was then diluted with distilled water in the ratio of 1:10
  • Step 3: Ten milliliter of the diluted plasma and 1 mL of 1% acetic acid were added to achieve a pH 5.3. It was then centrifuged at the speed of 3000 rpm for 5 min till the precipitate formed
  • Step 4: The precipitate was dissolved in 10 mL normal saline
  • Step 5: 0.1% calcium chloride and sodium bicarbonate was added till pH became 7. A precipitate was formed, which was removed, leaving a clear fluid beneath which contained thrombin. This was stored at 20°C.[5]


Thrombin and fibrinogen were mixed for making the autologous tissue glue [Figure 1],[Figure 2],[Figure 3],[Figure 4],[Figure 5].
Figure 1: Flow chart depicting preparation of autologous tissue glue

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Figure 2: Preparing fibrinogen and thrombin in vitro

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Figure 3: Mixing the two in vitro for making tissue glue

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Figure 4: Fibrinogen and thrombin prepared preoperatively

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Figure 5: Mixing fibrinogen and thrombin intraoperatively

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Figure 6: Gel foam.soaked in tissue glue being applied over the edges during graft placement

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In Group I, out of 50 cases, 28 were male and 22 were female. The mean age of the patients was 48 years. Successful graft uptake was seen in 42 cases (84%) [Table 1],[Table 2],[Table 3],[Table 4].
Table 1: Size of perforation

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Table 2: Graft uptake

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Table 3: Hearing improvement

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Table 4: Problems with graft uptake

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In Group II, out of 50 cases, 31 were male and 19 were female. The mean age of the patients was 42 years. Successful graft uptake was seen in 46 cases (92%) [Table 1],[Table 2],[Table 3],[Table 4].


  Discussion Top


Sequelae of mucosal inactive otitis media is permanent perforation with conductive hearing loss. In order to restore the hearing and to repair the perforation one has to graft the tympanic membrane which is usually done by a temporalis fascia graft. There is no fixation of the graft in the recipient site, i.e., the drum remnant, such as sutures etc., A new method of fixation is now being attempted with autologous fibrin glue.[6]

Fibrin glue is derived from autologous fibrin produced from a group of blood products. This is formed by a series of chemical reactions that lead to formation of fibrin clot at site of application. It consists of fibrinogen and thrombin. It is a revolution for local hemostatic measure for both bleeding and nonbleeding disorder. It is useful for adhesion, sealing, anastomosis, vascular graft, and nerve graft, etc.

The first limited applications for this fibrin glue during surgical procedures in humans occurred in 1974. Of interest, the fibrinogen source for the glue was autologous cryoprecipitate, prepared from patient plasma. That procedure was used as the basis for the production of several different commercial products that entered clinical use in the late 1970s and early 1980s. These early products used lyophilized fibrinogen concentrates derived from large plasma pools and bovine thrombin rather than cryoprecipitate. Such commercial products-Tisseel and Tissucol (Immuno AG, Vienna, Austria); and Beri-plast (Beringwerke AG, Marburg, Germany) are in greatest clinical use. The use of Tisseel has been most widely reported in the literature.[7] These commercial preparations have certain disadvantages:

  1. They are expensive and cannot be used extensively in patients due to the cost
  2. These contain bovine protein (aprotinin). Even in the strict local application, there is a risk of anaphylactoid reaction, linked to the presence of bovine aprotinin. Life-threatening anaphylactoid reactions and/or thromboembolic complications may occur if the preparation is unintentionally applied intravascularly. Thus cannot be used in patients with allergic heparin-induced thrombocytopenia and intolerant to bovine products. There is a minimal risk of transmission of prions by aprotinin with bovine origin
  3. Thrombin and factor XIII are made from the human plasma. Although standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations, but, despite this, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses or other pathogens. The measures taken are considered effective for enveloped viruses such as HIV, hepatitis B virus, and hepatitis C virus. The measures taken may be of limited value against small nonenveloped viruses such as parvovirus B 19 and HAV.[8]


In house prepared autologous tissue glue provides us an ideal tissue seal for use in tympanoplasty because of:

  1. Low cost: As it is prepared in house
  2. Is biocompatible
  3. Has high compound strength
  4. Prepared from the patient's own blood components thus the chances of reaction are very less whereas the chances of cross infection are none
  5. Easy to administer during surgery with various options as per individual cases
  6. Can be tailor made in each case according to the requirement.


Thrombin in tissue glue helps in activation of wound healing related receptors whereas fibrinogen helps in angiogenesis and promoting cell adhesion and migration.[9]

COM is a big burden on our society as it is a disease of mainly low socioeconomic status. Thus in house autologous tissue glue in tympanoplasty will be a good option, as it is economical to the patients with improved success rate of the surgery specially in developing countries with limited infrastructure and nonaffording patients.[10]

Tissue glue is reported to be safe for use in ear surgeries. Siedentop et al.[11] in their experimental surgery on 43 middle ears of chinchillas, documented this by histological evidence obtained 45 days after operation, the validity of the following two hypotheses was established: That fibrin tissue adhesive placed upon the footplate of the stapes is biologically compatible, biodegradable and does not cause toxic, inflammatory or foreign body reactions, or other tissue damage to middle ear structures and that a small piece of bone glued on the long process of the incus with fibrin tissue adhesive shows permanent tissue union. In addition, in cases where the inner ear was accidentally opened by surgically subluxating the stapes and adhesive was free to enter the vestibule, evidence was obtained that there was no damage to inner ear structures.[11]

A study conducted by Kaushik and Jain[12] in 2017 had a success rate of 90% in 60 cases of COM repaired using tissue glue. Yuasa and Yuasa[13] in their study of underlay myringoplasty with fibrin glue for repair of tympanic membrane perforation reported a success rate of 97.3% with reduction in air bone gap of 10.3 dB.[13] Evandro et al.[14] had a success rate of 80.6% in 31 cases of myringoplasties done using tissue glue.[14] Our study had similar results.

Mohanty and Kurian[15] in a study done on 33 cases of Type 1 tympanoplasty using fibrin glue showed that the mean average of PTA in preoperative was 34.45 dB which improved to 24.55 dB 3 months after the surgery and to 21.73 dB 6 months after the surgery thus showing that fibrin glue provide good hearing outcome postoperatively and can be used especially in patient with large perforation. In our study there was reduction of AB Gap from 33.4 dB to 24 dB. This study also shows results in accordance with these previous studies.


  Conclusion Top


In house autologous tissue glue is ideal graft-securing agent in tympanoplasty. However, a longer follow-up is required to analyze the results.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Agrawal A, Bhargava P. Comparative evaluation of tympanoplasty with or without mastoidectomy in treatment of chronic suppurative otitis media tubotympanic type. Indian J Otolaryngol Head Neck Surg 2017;69:172-5.  Back to cited text no. 1
    
2.
Sengupta A, Basak B, Ghosh D, Basu D, Adhikari D, Maity K. A study on outcome of underlay, overlay and combined techniques of myringoplasty. Indian J Otolaryngol Head Neck Surg 2012;64:63-6.  Back to cited text no. 2
    
3.
Mundra RK, Sinha R, Agrawal R. Tympanoplasty in subtotal perforation with graft supported by a slice of cartilage: A study with near 100 % results. Indian J Otolaryngol Head Neck Surg 2013;65:631-5.  Back to cited text no. 3
    
4.
Hartman AR, Galanakis DK, Honig MP, Seifert FC, Anagnostopoulos CE. Autologous whole plasma fibrin gel. Intraoperative procurement. Arch Surg 1992;127:357-9.  Back to cited text no. 4
    
5.
Quick AJ, Perry JB, Hussey CV. Production of thrombin from precipitate obtained by acidification of diluted plasma. Am J Physiol 1955;183:114-8.  Back to cited text no. 5
    
6.
Batni G, Goyal R. Hearing outcome after Type I tympanoplasty: A retrospective study. Indian J Otolaryngol Head Neck Surg 2015;67:39-42.  Back to cited text no. 6
    
7.
Behrens AM, Sikorski MJ, Kofinas P. Hemostatic strategies for traumatic and surgical bleeding. J Biomed Mater Res A 2014;102:4182-94.  Back to cited text no. 7
    
8.
Sreevastava DK, Tarneja VK. Anaphylactic Reaction: An Overview. Med J Armed Forces India 2003;59:53-6.  Back to cited text no. 8
    
9.
Schneider G. Tissue adhesives in otorhinolaryngology. Laryngorhinootologie 2009;88 Suppl 1:S156-64.  Back to cited text no. 9
    
10.
Gugerell A, Pasteiner W, Nürnberger S, Kober J, Meinl A, Pfeifer S, et al. Thrombin as important factor for cutaneous wound healing: Comparison of fibrin biomatrices in vitro and in a rat excisional wound healing model. Wound Repair Regen 2014;22:740-8.  Back to cited text no. 10
    
11.
Siedentop KH, Harris DM, Loewy A. Experimental use of fibrin tissue adhesive in middle ear surgery. Laryngoscope 1983;93:1310-3.  Back to cited text no. 11
    
12.
Kaushik S, Jain R. A study of the role of tissue adhesives in myringoplasty. J. Evolution Med Dent Sci 2017;6:2101-4.  Back to cited text no. 12
    
13.
Yuasa Y, Yuasa R. Postoperative results of simple underlay myringoplasty in better hearing ears. Acta Otolaryngol 2008;128:139-43.  Back to cited text no. 13
    
14.
Evandro JP, Aquino D, Alves RV, Giancoli SM, Brandao FH, Zavarezzi DE, et al. De aquino fibrin tissue adhesive: Concepts and applications on 31 myringoplasty. Int Arch Otorhinolaryngol 2005;9:2-6.  Back to cited text no. 14
    
15.
Mohanty S, Kurian AT. Audiological outcomes of Type 1 tympanoplasty done with Fibrin Glue. J Otol Rhinol 2016;5:45-7.  Back to cited text no. 15
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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