Comparative Study of Efficacy of Temporalis Fascia vs Dehydrated Human Amniotic Membrane as Graft Material in Myringoplasty- A randomized controlled trial”.

Perforation of the Tympanic Membrane (TM) is a common complication of various types of pathologies of the middle ear, mostly infective in origin. A group of patients require plastic surgical repair of the TM perforation. The operative procedure involves the placement of some graft material as a template, upon which, the fresh epithelium grows to cover up the perforation and the healing is achieved. Experiments have been going on for the search of an ideal graft material for a long time. Various tissue materials e.g. perichondrium of the adjacent cartilages, vein graft, spilt thickness skin, cartilage (Homograft/ Allograft), dermal fat, Temporalis fascia and  synthetic materials like cigarette paper, silastic sheet, Gelfoam. Surgicel etc. have been tried by various research workers. Among these, the use of the Temporalis fascia is most popular and common. However, each and every graft material has its advantages and limitations. Recently, commercially available allograft materials such as Alloderm (Life Cell Corp., Branchburg, NJ) derived from donated skin from human cadavers has been used as an alternative to autologous tissue in efforts to reduce scarring, infection and pain, as well as operative time. Although, this material may provide a suitable grafting option, it’s acellular characteristic only serves as a scaffold or template for in-growth, which may limit its long-term success [1.6.9.11]. An important component of tissue engineering  (TE)  is the supporting matrix upon which cells and tissues grow, also known as the scaffold. Scaffolds must easily integrate with host tissue and provide an excellent environment for cell growth and differentiation. Most scaffold materials are naturally derived from mammalian tissues. The amniotic membrane (AM)  is considered an important potential source for scaffolding material. The AM represents the innermost layer of the placenta and is composed of a single epithelial layer, a thick basement membrane and an avascular stroma. The special structure and biological viability of the AM allows it to be an ideal candidate for creating scaffolds used in TE. Epithelial cells derived from the AM have the advantages of stem cells, yet are a more suitable source of cells for TE than stem cells. The extracellular matrix components of the basement membrane of the AM create an almost native scaffold for cell seeding in Tissue engineering. In addition, the Amniotic membrane has other biological properties , including anti-inflammatory, anti-microbial, anti-fibrosis, anti-scarring, as well as reasonable mechanical property and low immunogenicity [2.7.10.12.15.17].

Keeping the above properties of amniotic membrane in mind an ‘Experimental Study’ ‘is proposed to be conducted among patients attending the out-patients wing of Otorhinolaryngology Department of College of Medicine & Sagore Datta Hospital (COMSDH) and Bidhan Nagar State General Hospital (BNSGH- situated within a radius of 50 kms of COMSDH) to compare the efficacy of  Temporalis Fascia vs Dehydrated Human Amniotic Membrane as graft material in Myringoplasty.

The study will be conducted over a span of about 2years among subjects selected through proper inclusion and exclusion criteria. The objectives will be To study the effects of Myringoplasty for Tympanic Membrane Perforation with Temporalis Fascia Graft vis-à-vis Dehydrated Human Amniotic Membrane on the healing parameters of the operated patients & Comparative assessment of efficacy on the healing effects of the two different graft materials. Data will be collected as per pre-designed pro-forma and relevant investigations followed by definitive surgical management will be done.

After approval from the Technical Advisory Committee and the Institutional Ethics Committee, data collection and statistical analysis of the study will be done and published in due course.