Title: Outpatient Use of Integra® and Subatmospheric Pressure in the Management of Wound and Burn Reconstruction Authors: Dean DeRoberts, M.D., Christopher A. Park, M.D., Anthony J. DeFranzo, M.D., Malcolm W. Marks, M.D., Joseph A. Molnar, M.D., Ph.D. Wake Forest University School of Medicine, Winston-Salem, NC Introduction: Integra® (Integra Lifesciences Corporation, Plainsboro NJ) is an artificial dermis derived from bovine collagen and chondroitin-6-phosphate. It possesses a matrix that allows for ingrowth of capillaries and fibroblasts. As it was designed to be a dermal regeneration template with natural metabolic turnover, the hope was that the ultimate skin produced from this product would more resemble skin than scar (1). It is covered with a silicone layer that functions as a temporary epidermis. This silicone layer is removed after engraftment of the dermal matrix and a thin split-thickness skin graft is applied. The product was originally designed to be life saving for patients with extensive burns. This application has been well evaluated in earlier studies in multiple centers (2,3). However, Integra® has found many other uses recently, including treatment of contractures and complex wounds (4,5). The proposed benefit of wounds treated with Integra® and subsequent skin graft compared to skin graft alone include increased thickness and durability, improved mobility and cosmesis, reduced recurrence of contractures and keloids, and the ability to cover exposed tendons, muscles, and joints. Traditional management of Integra® required antibiotic dressing changes for 2-4 weeks to allow vascularization prior to skin graft. The application of Integra® using subatmospheric pressure (V.A.C.®, KCI Inc., San Antonio TX) has been suggested to be easier, faster, and more consistent than previous dressings. The use of subatmospheric pressure has allowed grafting as soon as 5 days after Integra® placement with no interval dressing changes minimizing the tedium and morbidity of standard dressings (5). Concerns of cost in the use of Integra® with the V.A.C.® have limited its use. These costs could be minimized by using this technique in an outpatient setting sparing the expense of hospital stay. Methods: Ten patients were chosen for outpatient reconstructive surgery with Integra® and subatmospheric pressure. Age range was 4 – 58 years. Five patients underwent burn reconstruction (axillary and antecubital fossa contracture release), one patient underwent scalp keloid excision and reconstruction, one patient required coverage of a toe defect after Mohs excision of squamous cell carcinoma, and three patients underwent reconstruction of traumatic foot/ankle wounds. Wound sizes ranged from 7.5 – 276 cm2. After wound preparation and Integra® application in the operating room, the V.A.C. was applied as the dressing. The patients were admitted for overnight stay in our observation hospital for pain management and verification of V.A.C. function. Patients were discharged on postoperative day one with home V.A.C (one patient was discharged immediately postoperatively). Some patients were seen in the clinic in 3 – 5 days for a wound check but others were managed entirely at home. Patients returned to the operating room 7 – 10 days later for V.A.C. removal and split thickness skin grafting. The V.A.C. was again applied as a post-graft dressing and the patient was discharged on an outpatient basis (one patient stayed in observation hospital overnight) before returning in 4 days for V.A.C. removal in the clinic (Table 1). Results: All patients were successfully reconstructed with near complete take of Integra® at the time of grafting. Split thickness skin graft takes ranged from 75 - 100%; mean 92% (Table 2). No patients required additional grafting. Conclusion: Integra® may be successfully used for reconstruction of difficult areas as an outpatient in combination with subatmospheric pressure (V.A.C.®). This allows for successful reconstruction, expedited treatment versus standard Integra® application, and decreased morbidity and costs. Further prospective studies are required to demonstrate the cost savings, uses, and limitations of this technique. Table 1: Length of Stay (Days) PATIENT 1 2 3 4 5 6 7 8 9 10 MEAN INTEGRA 1 1 1 1 1 1 1 0 0 1 0.8 INTERVAL 7 9 9 7 7 7 8 10 7 9 8 SKIN GRAFT 0 0 0 1 0 0 0 0 0 0 0.1 Table 2: Percent Graft Take PATIENT 1 2 3 4 5 6 7 8 9 10 MEAN PERCENT 100 90 95 75 85 95 98 85 97 95 92% References: 1. Honari, S., Gibran, N. S., Engrav, L. H., Clayney, C., and Heimbach, D. M. Three years’ experience with 52 Integra (artificial skin) patients since FDA approval. J. Burn Care Rehabilitation. 2000, 21:190. 2. Sheridan, R. L., Hegarty, M., Tompkins, R. G., and Burke, J. F. Artificial skin in massive burns: Result to ten years. Eur J Plastic Surgery 1994, 17:91. 3. Moiemen, N. S., Staiano, J. J., Ojeh, N. O., et al. Reconstructive surgery with a dermal regeneration template: Clinical and histologic study. Plastic and Reconstructive Surgery 2001, 108:93. 4. Orgill, D. P., Straus, F. H., II, and Lee, R. C. The use of collagen-GAG membranes in reconstructive surgery. Ann N.Y. Acad Sci 1999, 888:233 5. Molnar, JA et al. Acceleration of Integra Incorporation in Complex Tissue Defects with Subatmospheric Pressure. Plastic and Reconstructive Surgery April 2004, 113(5):1339–1346. This paper was presented in part at the annual meeting of the American Burn Association, Chicago, Illinois, May 13, 2005. Joseph A. Molnar, MD, Ph.D., receives research funds from KCI, Inc. (the manufacturer of the V.A.C.®) and receives compensation for presentations at educational symposia sponsored by KCI, Inc. Joseph A. Molnar, MD, Ph.D., receives research funds from Integra Life Sciences, Inc. (the manufacturer of Integra Dermal Regeneration Template) and receives compensation for presentations at educational symposia sponsored by Integra Life Sciences, Inc.