Title: Revascularization of Human Acellular Dermis Matrix when used for Ventral Hernia Repair – A Rabbit Model Authors: Nathan G. Menon MD, Eduardo D. Rodriguez DDS, MD, Nelson H. Goldberg MD, Ronald P Silverman MD. Division of Plastic Surgery, University of Maryland, School of Medicine Introduction: In general, the first choice in reconstructing extensive abdominal wall defects involves the use of prosthetic material. Prosthetic materials such as expanded polytetrafluoroethylene (GoreTex ) while frequently used, do not get revascularized and hence its use is limited to applications at low risk for infection. Previous work in the rabbit model has shown that autologous thoracodorsal fascia when used for abdominal wall reconstruction becomes revascularized, retains its cellular architecture, and resists infection better than prosthetic material1. Clinically, autologous tensor fascia lata has confirmed our laboratory findings. Despite clinical success in abdominal wall reconstruction with autologous tensor fascia lata, donor site morbidity remains problematic. One study over a ten-year period reports a 30% donor site complication rate, largely consiting of seromas and hematomas2. Therefore, a prosthetic material that supports vascular ingrowth would be a useful reconstructive option and would not involve the use of a donor site nor subject the patient to the relatively high complication rate. This study investigates if human acellular dermis (AlloDerm) supports vascular in-growth when used to reconstruct full thickness abdominal wall defects in the rabbit model. AlloDerm® (manufactured by Life Cell Corporation, Woodlands, TX) is an acellular dermal matrix processed by a proprietary protocol from human cadaver skin. The epidermis of the cadaver skin is separated from the dermis using a high ionic-strength solution, which uncouples the bond between the two layers; the cells in the dermis remain undamaged by this process. The dermal cells are then removed from the dermis using sodium deoxycholate and the material is then freeze-dried. The end-product of the protocol results in a biomaterial containing components of types IV and VII collagen, elastin, and laminin, which are undamaged within the residual dermal matrix3. This material has already shown to be efficacious in the treatment of full thickness burns4, as a substrate material for oral resurfacing and periodontics5. Furthermore AlloDerm® has shown promise as a soft tissue filler in plastic surgery6 and is used as a viable option for dural replacement in neurosurgical cases where autogenous tissues are either unavailable or insufficient for proper reconstruction7. If it can be conclusively shown that AlloDerm® revascularizes similar to fascial autograft, then abdominal wall reconstruction can be accomplished without the need for a donor site. A material that revascularizes when used as an implant would be an useful reconstructive option especially in patients with large ventral hernias who are at high risk for postoperative infection. Methods: A full-thickness abdominal wall defect was created in 25 rabbits. This defect was repaired (1) in Group A with an Alloderm patch (n = 10 rabbits), (2) in Group B with a GoreTex patch (n = 10 rabbits), and (3) in Group C with primary closure using a continuous non-absorbable #0 Prolene® suture (n = 5 rabbits). The defect measured 3cm x 7cm in groups A and B whereas the defect in Group C measured 0.5cm x 7cm. After 30 days the following endpoints were evaluated: (a) the incidence of herniation (b) the size of repaired patch at harvest in Groups A and B, (c) the presence of intra-abdominal adhesions (d) the breaking strength of the patch–fascia interface (with the suture removed), and (e) assessment of vascular in-growth into the patch by fluorescein-dye infusion and histological analysis. Results: There was no incidence of herniation in any of the rabbits in the three groups. The size of the patch was unchanged in all rabbits except for 2 rabbits in the Alloderm group (20%) but the increase in size was not statistically significant when compared to the GoreTex group (p > 0.05). Visceral adhesions to the patch were found in all the GoreTex group rabbits, but no such adhesions were present in the other two groups. There was no significant difference between the mean breaking strength of the Alloderm-fascial interface (288.6 N/mm2 97.1 SD) and that of the GoreTex-fascial interface (337.0 N/mm2 141.2 SD). The mean breaking strength of the primary closure group with the suture removed (521.2 N/mm2 223 SD) was not only higher but also statistically different from both the Alloderm and GoreTex groups (p < 0.05). Infusion with flourescein dye and histological analysis revealed vascular in-growth into the Alloderm patch but not the GoreTex patch. Conclusions: This study demonstrates that human acellular dermis (Alloderm) functions at least as effectively as GoreTex in ventral hernia repair with fewer adhesions at one-month post operation in the rabbit model. Alloderm supports vascular in-growth within thirty days when used to reconstruct full thickness abdominal wall defects. A material that becomes vascularized holds much promise in patients with large ventral hernias who are at high risk for infection. A longer-term study in a larger animal model is certainly warranted. References: 1. Disa JJ, Klein MH, Goldberg, NH. Advantages of autologous fascia versus synthetic patch abdominal reconstruction in experimental animal defects. Plast. Reconst Surg. 97:801-806, 1996. 2. Disa JJ, Chiaramonte MF, Girotto JA, Klein MH, Goldberg NH. Advantages of Autologous Fascia versus synthetic patch abdominal reconstruction in experimental animal defects. Plast. Recons Surg. 108: 2086-2087, 2001. 3. Eppley BL. Revascularization of Acellular Human Dermis (Alloderm) in Subcutaneous Implantation, Aesthetic Surgery Journal – July/August 2000 4. Wainwright DJ, Madden M, Luterman L. Clinical evaluation of an acellular dermal matrix in full thickness burns. J Burn Care Rehabil 1996. 17: 124-136 5. Silverstein LH, Callan DP. An acellular dermal matrix allograft substitute for palatal donor tissue. Practical Pariodontic and Aesthetic Dentistry (PPAD). 3: 14-21, 1996. 6. Jones FR, Schwartz BM, Silverstein P. Use of a nonimmunogenic acellular dermal allograft for soft-tissue augmentation. Aesthetic Surg Q. 16: 196-201, 1996. 7. Constantino PD, et al. Human dural replacement with acellular dermis: clinical results and a review of the literature. Head & Neck, Dec 2000 765-771.