[Biswas et al., 3(4): April, 2014] ISSN: 2277-9655 Impact Factor: 1.852 http: // www.ijesrt.com(C)International Journal of Engineering Sciences & Research Technology [4080-4084] IJESRT INTERNATIONAL JOURNAL OF ENGINEERING SCIENCES & RESEARCH TECHNOLOGY Clinical Efficacy of an Indigenously Developed Tissue Expander B K Biswas *1 , S Pal 2 , S Bag 3 *1 KPC Medical College & Hospital, Jadavpur, Kolkata, India 2 School of Bioscience & Engineering, Jadavpur University, Kolkata, India 3 JIS College of Engineering, Kalyani, West Bengal, India sandipbag76@gmail.com Abstract Reconstruction of tissue defects in face with the similar kind of tissue is very challenging as the skin of the other parts of the body does not match properly. Recently tissue expansion using tissue expander is being used more frequently in reconstructive surgery for the treatment of a variety of problems in both children and adults. The concept of tissue expansion has opened a whole new frontier in reconstructive surgery. The tissue expansion technique is advantageous in facial reconstruction because it makes it possible to resurface wider defects with neighbouring skin that is similar in colour and texture. Conventional tissue expansion may result in epidermal hypertrophy, decreased dermal muscle and adipose thickness, bone resorption. To overcome such problem we have developed a tissue expander using medical grade silicone with a mixture of biocompatible materials which is highly flexible and cost effective. To determine the efficacy of new tissue expander requires animal experimentation followed by clinical trial. The result obtained from the clinical trial shows its biocompatibility as well as effectiveness. Keywords: Reconstruction, tissue expander, tissue expansion, flexible, biocompatibility. Introduction Tissue expansion is a reconstructive surgical technique which allows the body to "grow" extra skin where there has been tissue loss due to various reasons such as Burn, trauma or disease 1, 2, 3 . The most common application is in post-mastectomy breast reconstruction, but tissue expansion can be used in almost any part of the body following tissue loss due to any reason whatsoever 4, 5, 6, 7 . It is also quite advantageous for reconstruction of the scalp, because the “new” skin created contains matching colour and hair follicles (as opposed to using skin grafts or flaps from other parts of the body, which may leave bald spots on the scalp or mismatch of the colour) 8, 9, 10 . Tissue Expander is an implantable medical device used in plastic and reconstructive surgery for the development of extra tissue (Skin / Composite flaps) which is required for reconstruction of tissue defects and deficiencies (burn contracture ,congenital defects etc.) 11, 12 . The device is placed subcutaneously / below the muscle and injected periodically with sterile isotonic saline until the required tissue is fully developed 13 . The device is removed normally once the expansion is up-to the desired level (6-8 weeks). Presently there is no such company which is producing silicone tissue expander in India. It has tremendous scope and can be used in various clinical situations particularly Plastic and Reconstructive surgery of head, neck & face 14, 15, 16, 17 . If commercially available can solve a lot of reconstructive problems as well can help in earning foreign revenues too. The conventional tissue expander has some limitation such as less expansion ability, less flexible (because of thickness of the expander), formation of hard fibrous capsule over implantable expander (silicone though bio-compatible, but still produces some degrees of inflammatory reaction to the local tissues and over time it attracts bacteria over its surface which is also responsible for fibrosis) and high cost. Therefore aim of this present work is to develop indigenous cost effective tissue expanders which is more flexible and bio-friendly and has the ability of expansion in many folds, normally required in maxillofacial, plastic and reconstructive surgery. Fabrication of Tissue Expander Silicone rubber and liquid silicone rubber along with some biocompatible materials like titanium hydroxide (TiO2) were used as raw material in the study to fabricate the tissue expander. To fabricate such tissue expander special type of moulds with heating arrangement was used. The moulds were