Abstract
To compare the efficacy of platelet rich plasma (PRP) in Tympanoplasty. Comparative study of Tympanoplasty with and without PRP. A total of 82 patients having dry large central perforation underwent type I Tympanoplasty by transcanal route under local anesthesia. Control group underwent surgery without PRP. The study group Tympanoplasty was added with PRP by PRP soaked gel foam placed in middle ear, over the graft and in bony canal along with wetting the temporal fascia by PRP graft. Preoperative and post operative audiometry was done. Result compared. Majority of the patients were of the age group of 20–30 years. Success rate of graft uptake was 85.3% in control group and 95.1% in PRP group. Hearing Improvements in control group was 46.3% and in PRP group was 78.0%. This study confirms addition of PRP in Tympanoplasty enhances the success rate in graft uptake early healing with improvement in hearing.
Keywords: Tympanoplasty, Platelet rich plasma, Sensorineural deafness, Tympanic membrane perforation, C.S.O.M., Trans canal myringoplasty, Discharging ear
Introduction
The success rate of graft uptake, improvement in hearing, secondary or recurrent perforation or adhesion formation in Tympanoplasty varies in different studies. We are always in search to find out a technique to provide better results. Various studies have been conducted using platelet rich plasma to improve the surgical outcomes in tympanoplasty [1] and hearing improvement in sensorineural hearing loss [2]. Since Platelet rich plasma is easy to procure and its addition in the middle ear cavity may have some more improvement in terms of sensorineural hearing loss apart from early healing and better success in Tympanoplasty.
It is an era of regenerative medicine we discuss of cloning, stem cells therapy or platelet rich plasma to regenerate or promote growth of body tissue or organ [3, 4]. Platelet rich plasma is easiest to procure and to use it in human body. Since it is autologus practically it does not have any significant side effect. Plasma is the liquid portion of whole blood made up mainly of water and proteins. Plasma provides medium to red blood cells, white blood cells and platelets to circulate in the body. Platelet also known as thrombocytes conventionally known for blood clotting, it releases many growth factors at the site of injury which promotes repair and healing. Since now we know that body has inbuilt power of healing hence if we aggravate the healing or growth factors undoubtedly repair will be much better. The scientist came out with a technique to condense and provide growth factors at the site of injury by platelet rich plasma. We can define platelet rich plasma as a volume of autologus plasma of blood which has been enriched with platelets and growth factors.
There are four categories of platelet rich plasma (PRP) on the basis of leukocytes and fibrin contents (1) leukocyte rich PRP, (2) leukocyte reduced PRP, (3) leukocyte platelet rich fibrin, (4) pure platelet rich fibrin.
The addition of thrombin and calcium chloride induces the release of growth factor. The regenerative potential depends upon the release of growth factors.
Platelet has a reservoir of growth factors and cytokines which support govern and enhance the tissue healing.
The bioactive molecule secreted by platelet granule are involved in proliferation, differentiation of cells having anabolic and pro inflammatory response optimizing the tissue environment and favoring healing process. The bioactive agents, serotonin, dopamine, adenosine and calcium increase the cell permeability and modulate the repair. The principle growth factor and cytokines released are:
Platelet-derived growth factor.
Transforming growth factor beta.
Fibroblast growth factor.
Insulin-like growth factor 1.
Insulin-like growth factor 2.
Vascular endothelial growth factor.
Epidermal growth factor.
Interleukin 8.
Keratinocyte growth factor.
Connective tissue growth factor.
Addition of thrombin and calcium chloride induces the release of growth factors. The calcium chloride addition induces a progressive release of growth factor [5].
This study evaluates the use of activated platelet rich plasma placed in the middle ear cavity and on both sides of temporal fascia graft. Graft take up rate, improvement in air conduction, bone conduction and incidence of secondary perforation in Myringoplasty with conventional techniques.
Material and Method
It was a randomized controlled study of 82 patients divided in two groups 41 each having a large, dry central perforation with no clinical sign of cholesteatoma or ossicular necrosis.
Inclusion Criteria
Large central perforation.
Dry middle ear cavity.
No active disease of nose and throat.
Exclusion Criteria
Sign of cholesteatoma or ossicular necrosis.
Anaemia.
Chronic liver or kidney disease.
Haemodynamic instability.
Diabetes.
Fluctuating hypertension.
Hypofibronogenemia.
Platelet dysfunction syndrome.
Low platelets counts.
Inlay Transcanal Myringoplasty was performed under local anesthesia. Temporal fascia graft was harvested, dried and made wet by platelet rich plasma during placement.
Preparation of Autologus Platelet Rich Plasma
The blood was obtained from antecubital vein using 16/18 number scalp vein set in specific tube having 1 ml of anticoagulant, 9.0 ml of blood was collected. Immediately centrifugation of blood was done at automatic centrifugation machine using 1500 rpm for 15 min. This resulted in two layers upper one yellowish and lower one dark red. By using a sterile pipette supernatant plasma was transferred to another sterile tube for hard spin. Second centrifugation was done at 3000 rpm for 15 min, upper supernatant platelet poor plasma was sucked gently with pipette after leaving 1 ml of fluid and pallet at the bottom.
Now with another sterile pipette gently mixed the pallet in the fluid, preserved to be used during surgery.
Immediately before use 0.1 ml of calcium gluconate was added to activate the release of growth factor. This PRP was added to just sufficient quantity of gel foam going to be used in surgery two drops of PRP was installed on each side of dried temporal fascia graft. The graft was placed medial to handle of malleus after lifting 360° tympanomaetal flap. Repositioning of anterior segment was done meticulously to prevent anterior blunting. PRP wet gel foam placed over the graft pressing the graft to squeeze out any air or blood between the graft and bone. Thin ribbon pack was placed in cartilaginous portion external auditory canal. Pack was observed on alternate days and gentle suction done over it. Ribbon pack removed on 7th day and condition of gel foam observed. Patient was given 2 days injectable antibiotic and 10 days oral antibiotics along with analgesic antihistamines, vitamin C and Vitamin D supplementation [6, 7]. We should always avoid ototoxic drugs [8].
Results
Eighty-two patients full filling the inclusion criteria were the subject of study and under went Myringoplasty from 1st Jan 18 to 30th Dec 18 with having usually large central perforation. The age of patients was from 14 to 72 years most of the patients were in the age group of 21–30 years. In our study number of males were more. Male female ratio was 2:1. Mean duration of symptoms was 13 months varying from 6 years to 7 months. Left side sickness was predominant 1.3:1. Dry perforation and rejection in medical fitness during recruitment was the main symptom followed by recurrent discharge and impairment of hearing (Tables 1, 2).
Table 1.
Age and sex distribution
| Number of patients age | PRP cases | Control | Total | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Male (n) | Female (n) | Male (n) | Female (n) | |||||||
| No. | % | No. | % | NO. | % | No. | % | No. | % | |
| 14–16 | 2 | 4.9 | 1 | 2.4 | 1 | 2.4 | 1 | 2.4 | 5 | 6.09 |
| 16–30 | 20 | 48.7 | 3 | 7.3 | 13 | 31.7 | 10 | 24.3 | 46 | 56.09 |
| 30–40 | 6 | 14.6 | 2 | 4.9 | 4 | 9.7 | 4 | 9.7 | 16 | 19.5 |
| 40–50 | 4 | 9.7 | 1 | 2.4 | 3 | 7.3 | 4 | 9.7 | 12 | 14.6 |
| 50–70 | 2 | 4.9 | 0 | 0 | 0 | 0 | 1 | 2.4 | 3 | 3.6 |
| Total patients | 34 | 82.8 | 7 | 17.0 | 21 | 51.1 | 20 | 48.5 | 82 | 100 |
Table 2.
Comparison of graft take up rate
| Group | ||||||
|---|---|---|---|---|---|---|
| PRP cases | Controls | Total | ||||
| Count | % | Count | % | Count | % | |
| Graft status | ||||||
| Failure | 6 | 14.6 | 2 | 4.9 | 8 | 9.7 |
| Success | 35 | 85.3 | 39 | 95.1 | 74 | 90.3 |
| Total | 41 | 100 | 41 | 100 | 82 | 100 |
All the patients under went same surgical protocol out of which randomly selected in forty-one patients platelet rich plasma was added. In control group. Success rate after 6 months was 85.3% while with platelet rich plasma was (95.1%).
Discussion
With better surgical equipments, sterilization, acumen and antibiotics success rate is increasing but results vary from 56 to 100%. The PRP enrich gelfoam has been used with 66% success rate as compared to 25% without PRP [9] while alvaroetal. Has observed 100% success rate with PRP [10]. In our study there was considerable improvement in success rate from 86% to (95.1%) Platelet rich plasma (PRP) enhances healing process and the best part is being antimicrobials chance of secondary infection are less [11]. PRP is known to prevent adhesion formation due to modulation of optimized cell proliferation which is one of the most common segualae observed in cases when there is regression of hearing after initial improvement. Closing the perforation of the tympanic membrane eliminates the anatomical defect, prevents recurrence of inflammatory process in the middle ear, and prevents development of sensorineural hearing loss or other complications [12, 13]. The graft rejection or migration could be due to central to peripheral growth pattern. Any substance which promotes fast and effective growth could avoid migration hence PRP may enhance success rate by preventing migration and rejection of graft [10].
PRP may restore permeability of round window membrane and by virtue of growth factor may take care of early sensorineural hearing loss. Adding calcium makes it get like to stay in position hence helps to keep the graft in position during placement and in post operative period. Various studies have shown encouraging results in clinical as well as in experimental studies.
Hearing improvement (> 10 dB) was observed in control group in (46.3%) and in PRP group in (78.0%).
Conclusion
Platelet Rich Plasma being of autologus origin is easy to procure with practically no side effect healing is faster. In our study no complication or side effects was observed while results were comparatively better after adding PRP hence in future adding PRP at place of local antibiotic or glue may come out as a better alternative with improved outcome of surgery.
Footnotes
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References
- 1.El-Anwar MW, EL-Ahl MAS, Zidan AA, Yacoup MARAS. Topical use of autologous platelet rich plasma in myringoplasty. Auris Nasus Larynx. 2015;42(5):365–368. doi: 10.1016/j.anl.2015.02.016. [DOI] [PubMed] [Google Scholar]
- 2.Tyagi BBPS, Rout M. Platelet rich plasma (PRP): a revolutionary treatment of sensorineural hearing loss. Acta Sci Otolaryngol. 2019;1(4):2–5. [Google Scholar]
- 3.Vannini F, Di Matteo B, Filardo G, Kon E, Marcacci M, Giannini S. Platelet-rich plasma for foot and ankle pathologies: a systematic review. Foot Ankle Surg. 2014;20(1):2–9. doi: 10.1016/j.fas.2013.08.001. [DOI] [PubMed] [Google Scholar]
- 4.Zhu Y, Yuan M, Meng HY. Basic science and clinical application of platelet-rich plasma for cartilage defects and osteoarthritis: a review. Osteoarthr Cartil. 2013;21(11):1627–1637. doi: 10.1016/j.joca.2013.07.017. [DOI] [PubMed] [Google Scholar]
- 5.Cavalio C, Roffi A, Grigolo B, Mariani E, et al. Paltelet-rich plasma: the choice of activation method affects the release of bioactive molecules. Bio Med Res Int. 2016;2016:1–7. doi: 10.1155/2016/6591717. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6.Saeedi M, Ajalloueian M, Zare E, Taheri A, Yousefi J, Mohammad S, Mirlohi J, Aref NM, Saeedi Mohammad J, Khosravi MH. The effect of PRP-enriched gelfoam on chronictympanic membrane perforation: a double-blind randomized clinical trial. Int Tinnitus J. 2017;21(2):108–111. doi: 10.5935/0946-5448.20170021. [DOI] [PubMed] [Google Scholar]
- 7.Taneja MK. Role of vitamin D in prevention of deafness. Indian J Otol. 2012;18:55–57. doi: 10.4103/0971-7749.100692. [DOI] [Google Scholar]
- 8.Taneja MK, Taneja V. Vitamin d deficiency in ENT patients. Indian J Otolaryngol Head Neck Surg. 2013;65:57–60. doi: 10.1007/s12070-012-0603-9. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9.Taneja MK, VarshneyHimanshu Taneja Vivek, VarshneyJ J. Ototoxicity, drugs, chemicals, mobile phones and deafness. Indian J Otol. 2015;21:161–164. doi: 10.4103/0971-7749.161014. [DOI] [Google Scholar]
- 10.Navarrete Álvaro ML, Ortiz N, Rodriguez L, et al. Pilot study on the efficiency of the biostimulation with autologous plasma rich in platelet growth factors in Otorhinolaryngology: otologic surgery (tympanoplasty type I) ISRN Surg. 2011;2011:1–4. doi: 10.5402/2011/451020. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 11.Bielecki TM, Gazdzik TS, Arendt J, Szczepanski T. Antibacterial effect of autologous platelet gel enriched with growth factors and other active substances: an in vitro study. Br Vol. 2007;89-B(3):417–420. doi: 10.1302/0301-620X.89B3.18491. [DOI] [PubMed] [Google Scholar]
- 12.Ahmed Amin Omran Endoscopic bivalve inlay cartilage myringoplasty for central perforations: preliminary report. Egypt J Ear Nose Throat Allied Sci. 2012;13(1):37–42. doi: 10.1016/j.ejenta.2012.02.006. [DOI] [Google Scholar]
- 13.Lou Zhengcai. The outer diameter of the endoscope is important when performing endoscopic transcanalmyringoplasty. Braz J Otorhinolaryngol. 2017;83(6):730–731. doi: 10.1016/j.bjorl.2017.03.003. [DOI] [PMC free article] [PubMed] [Google Scholar]