Regenerative surgery uses biological matrices in order to repair damaged tissue.
Rectocele, abdominal wall repair, replacement of the dura mater, breast reconstruction, septoplasty and many other treatments are carried out with the aid of ADM matrices (1).
Acellular Dermal Matrix is the world's most used biomaterial for the correction of defects in tissue and there are many clinical studies that attest to its effectiveness and versatility (2,3). So why not take advantage of the regenerative potential of ADM for the correction of anal fistulas?
If not pulverized or cross-linked, ADM keeps the natural three-dimensional architecture of the collagen fibers. It speeds up the activity of the cells which transform the ADM in healthy self tissue (4).
The repair of damaged tissues occurs through a complex algorithm involving chemical, physical and biological processes. The cells involved are fibroclasts, responsible for the re-absorption of damaged tissue, and fibroblasts that produce new collagen reconstructing new tissue (5).
A resorbable (not cross-linked) ADM, when implanted, engages these actors which, in turn, will transform the Acellular Dermal Matrix into self tissue (4).
During the process of the transformation from ADM to self tissue there is a critical balance between
the phase of ADM re-absorption and tissue reconstruction (1).
The implantation of non re-absorbable matrices unbalance the cell turnover resulting in poor clinical outcomes and tissue repair failures (6). Cross-linked collagen paste is an example of non re-absorbable biomaterial (CND P900403).
The Pressfit® anal fistula plug is made of porcine dermal extracellular matrix.
The exclusive production process has been developed with the aim of generating a completely natural product (not crossed linked) without the presence of any chemical substance which can amplify the inflammatory response and slow the pathway of tissue regeneration. The native three-dimensional structure provides the benefit of immediate bio-availability for incorporation into the host tissue with lower inflammatory responses such a red-skin flare phenomenon seen following the implantation of other biomaterials used in anal fistula repair.
The natural Pressfit® matrix is made of native proteic polymers derived from acellularized tissue of porcine dermis (collagen). The organism recognises it as its own, and transforms it into self tissue through the natural regenerative process (remodelling). In order to allow Pressfit® anal fistula plug to be incorporated into the tissues without an amplified inflammatory response, the production process entails the sublimation (freeze drying ) in the final phases of the newly created acellular graft, which allows the complete removal of the liquid chemicals used in its preparation through exact use of pressure and temperature. This process makes the product dry, optimal for correct conservation at room temperature, and only requires a simple hydration before use, without the need for repeat washings to attempt the removal of damaging chemicals which other products require. Its patented shape allows a perfect fit modifying the inner cross-section of the fistula tract. It creates interference with the surrounding tissues enabling primary stability and intimate contact. It perfectly complies with biomechanical requirements to promote tissue regeneration.
The exclusive manufacturing method guarantees the highest integrity of the collagen. Without the need of adding preservative liquids, Pressfit® anal fistula plug is made of the ultimate ADM available by German biotechnology.
Adylak S F. Decellularized allogeneic and xenogeneic tissue as a bioscaffold for regenerative medicine: factors that influence the host response. Ann Biomed Eng, 2014; 42(7):1517-27.
Kulig KM, Luo X, Finkelstein EB, Liu XH, Goldman SM, Sundback CA, Vacanti JP, Neville CM. Biologic properties of surgical scaffold materials derived from dermal ECM. Biomaterials, 2013; 34(23):5776-84.
Badylak SF, Freytes DO, Gilbert TW. Extracellular matrix as a biological scaffold material: Structure and function. Acta Biomater, 2009; 5(1):1-13.
Jarman-Smith ML, Bodamyali T, Stevens C, Howell JA, Horrocks M, Chaudhuri JB. Porcine collagen crosslinking, degradation and its capability for fibroblast adhesion and proliferation. J Mater Sci Mater Med, 2004; 15(8):925-32.
Velnar T, Bailey T, Smrkolj V. The wound healing process: an overview of the cellular and molecular mechanisms. J Int Med Res, 2009; 37(5):1528-42.
Mestak O, Spurkova Z, Benkova K, Vesely P, Hromadkova V, Miletin J, Juzek R, Mestak J, Molitor M, Sukop A. Comparison of Cross-linked and Non-Cross-linked Acellular Porcine Dermal Scaffolds for Long-term Full-Thickness Hernia Repair in a Small Animal Model. Eplasty, 2014; 14:e22.