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临床试验/CTRI/2024/05/066644
CTRI/2024/05/066644已完成不适用

Use of Platelet Rich Fibrin Membrane (PRF) reinforcement in Type 1 Tympanoplasty

Dharmsinh Desai University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月13日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
1.Success rate of graft uptake in Group with PRF(%)

研究概览

简要总结

Summary/Purpose

Tympanoplasty is the surgery performed in Chronic Otitis Media (COM) to improve the hearing function and prevent ear discharge. Platelet Rich Fibrin (PRF) is one of the materials that can be used to improve the graft uptake and hearing outcome. It is obtained by centrifugation of blood. The PRF contains leukocytes, cytokines, structural glycoproteins and growth factors which accelerates healing. It has been used in various surgical procedures to improve the outcome.

Platelet-rich fibrin (PRF) which is considered a second-generation platelet-rich plasma having a high content of growth factors could be implied as a sealant and adjuvant to grafting materials during tympanoplasty operation [1].

 Tympanoplasty has been treated with various materials since its initial technique described by Berthold in 1878 where the remnant tympanic membrane was deepithelialized and a skin graft was applied over the defect.[2]

Various modifications of the graft materials were done since then by Zollner (1954), Frenckner (1955), Shea (1960) Heermann (1960), and many other surgeons. The fundamental principles of the surgical procedure were first described by Wullstein in 1952, using a free skin graft, and Zoellner in 1955, using a pedicle graft.[3]

Since then, several types of materials have been used to reconstruct the tympanic membrane, temporalis fascia, fascia lata, periosteum, perichondrium, cartilage with and without perichondrium, veins, fatty tissue, and skin.[4] Other allografts mentioned in the literature include dura mater, pericardium, amniotic membrane, skin, cornea, peritoneum, veins, and aortic valve.[5]

Recently, alloplastic grafts such as paper, absorbable gelatin sponge, and acellular dermal matrix have also been used.[6]

Each of the techniques was associated with its own advantages and disadvantages. However, fascia temporalis is the most commonly used graft, with success rates between 93% and 97% in primary tympanoplasty, especially in well-aerated middle ears.[7,8]

Although the literature shows the type of graft material used for closure of tympanic membrane (TM) perforations has been shown to have an effect on the outcome of surgery, there are no consistent success rates for achieving an intact tympanic membrane after surgery using different surgical techniques.[9]

A study by Kütük et al. in 2019, with 91 patients randomized into two groups; temporalis fascia graft alone and temporalis fascia with PRP, found better graft survival rates in patients who had temporalis fascia with PRP therapy, especially in those with larger perforations. Reperforations were noted in those who had more than 50% perforation preoperatively. Although hearing gain was greater in those patients who received PRP therapy, it was not statistically significant between the two groups.[10]

A study by S. Yadav et al. reported 95% graft uptake and 18.62 dB hearing improvement in PRF group, while 85% graft uptake and 13.15dB hearing improvement in no PRF group.[11]

A similar study done in India by Shanmugam R et al. proved the superiority of using PRF, showing 100% graft uptake with usage of PRF and hearing improvement of 13.75 dB.[12]

Kaur reported that PRF aids in the initial stability of the grafted tissue at the recipient sites. PRF allows rapid vascularization of the healing tissue by delivering growth factors that induce regeneration. The regeneration occurred due to super-saturation of the wound with PRF, growth factors [13].

Habesoglu et al. [14] in their study on closure of acute tympanic perforations concluded that the use of platelet-rich fibrin accelerates the tympanic membrane closure.

Garin et al. [15] also observed good safety of platelet rich fibrin without any adverse effect in middle ear packing.

References:

Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J et al (2006) Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part I: technological concepts and evolution. Oral Surg Oral Med Oral Pathol Oral Radiol Endodontol 101(3):e37– e44

Sarkar S. A review on the history of tympanoplasty. Indian J Otolaryngol Head Neck Surg 2013;65:455-60.

Zollner F. The principles of plastic surgery of the sound-conducting apparatus. J Laryngol Otol 1955;69:637-52.

Lee JC, Lee SR, Nam JK, Lee TH, Kwon JK. Comparison of different grafting techniques in type I tympanoplasty in cases of significant middle ear granulation. Otol Neurotol 2012;33:586-90.

Van Rompaey V, Farr MR, Hamans E, Mudry A, Van de Heyning PH. Allograft tympanoplasty: A historical perspective. Otol Neurotol 2013;34:180-8.

Haynes DS, Vos JD, Labadie RF. Acellular allograft dermal matrix for tympanoplasty. Curr Opin Otolaryngol Head Neck Surg 2005;13:283-6.

Malhotra M, Varshney S, Malhotra R, Joshi P. Indian perspectives on graft materials used for repair of tympanic membrane. J Clin Diagn Res 2017;11:ME01-6.

Kulkarni S, Kulkarni V, Burse K, Sancheti V, Roy G. Cartilage support for fascia graft in type I tympanoplasty. Indian J Otolaryngol Head Neck Surg 2014;66:291-6.

Indorewala S, Adedeji TO, Indorewala A, Nemade G. Tympanoplasty outcomes: A review of 789 cases. Iran J Otorhinolaryngol 2015;27:101-8.

Kütük SG, Özdaş T. Impact of platelet-rich fibrin therapy in tympanoplasty type 1 surgery on graft survival and frequency-specific hearing outcomes: A retrospective analysis in patients with tympanic membrane perforation due to chronic otitis media. J Laryngol Otol 2019;133:1068-73.

Yadav SP, Malik JS, Malik P, Sehgal PK, Gulia JS, Ranga RK. Studying the result of underlay myringoplasty using platelet-rich plasma. J Laryngol Otol. 2018;132(11):990-994. doi: 10.1017/S0022215118001846

Shanmugam R, Gnanavelu Y, Shanmugam VU, Swaminathan B, Nivas P, Bharath I. Myringoplasty with Autologous Platelet Rich Plasma - A prospective study. J Med Sci Clin Res. 2018;6(10):1170-1173. doi: 10.18535/ jmscr/v6i10.196

Kaur P (2011) Platelet-rich fibrin a novel bioengineering concept. Trends Biomater Artif Organs 25:86–90

Habesoglu M, Oysu C, Sahin S, Sahin-Yilmaz A, Korkmaz D, Tosun A, Karaaslan A. Platelet-rich fibrin plays a role on healing of acute-traumatic ear drum perforation. J Craniofac Surg. 2014;25(6):2056–2058. doi: 10.1097/SCS.0000000000001140. [PubMed] [CrossRef] [Google Scholar]

Garin P, Mullier F, Gheldof D, Dogne JM, Putz L, Van Damme JP. Platelet-rich fibrin (PRF): an autologous packing material for middle ear microsurgery. B-ENT. 2014;10(01):27–34. [PubMed] [Google Scholar]

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with age of 18 to 50years.
  • Having tubotympanic type of CSOM with central perforation Having dry ear for 6 weeks Voluntarily agree to participate with consent.

排除标准

  • Patients having complicated CSOM Patients with ossicular chain erosion Patients with cholesteatoma Not fit for surgery/Not willing for surgery Patient having SNHL or Mixed Hearing Loss Revision surgery.

结局指标

主要结局

1.Success rate of graft uptake in Group with PRF(%)

时间窗: Preoperative and Post op 3 months assessment

2.Success rate of graft uptake in Group without PRF(%)

时间窗: Preoperative and Post op 3 months assessment

次要结局

  • Hearing improvement in either group(Pre operative and Post operative (3 months post op) audiogram will be compared to see AB gap closure.(mean of AB gap closure))

研究者

发起方
Dharmsinh Desai University
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DrBhagyesh LDarji

Dr.N.D.Desai Faculty of Medical Sci. and research,Nadiad

研究点 (1)

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