Tdressing, cross-linked hydrogels, biological dressings, platelet-derived. Sepaderm for the Management of Acute and Chronic Wounds CASE SERIES

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1 CASE SERIES Sepaderm for the Management of Acute and Chronic Wounds Kerry Thibodeaux, MD, FACS; 1 S. William Tam, PhD 2 WOUNDS 2010;22(10): Abstract: The following case series includes a surgical excision, a burn wound, and a chronic venous ulcer that were successfully treated with From 1 The Wound Treatment Center, Sepaderm, a new wound management system. Sepaderm was chosen LLC at Opelousas General Health for its ease of use and its ability to remove excess exudate from the System; 2 Tam Consulting, Dover, wound bed. The system also limits exudate leakage onto periwound Massachusetts tissue and protects against direct contact with the wound bed. These cases provide initial evidence that the Sepaderm system performed Address correspondence to: well and facilitated healing of different wound types, including a previously nonhealing venous leg ulcer. Kerry Thibodeaux, MD, FACS The Wound Treatment Center, LLC at Opelousas General Health System PO Box 99, Opelousas, LA There T haved have been many new advances in wound dressings and treatment ted technologies, such as collagen/oxidized regenerated cellulose Phone: KThibodeauxMD@aol.com Tdressing, cross-linked hydrogels, biological dressings, platelet-derived growth factor-based therapy, synthetic matrices, and human cell-derived skin Disclosure: Dr. Tam is a paid con- substitutes (eg, Dermagraft [Advanced BioHealing, Westport, CT], 1 or sultant for Aalnex, Inc. Apligraf [Organogenesis, Canton, MA]). 2 Despite such product advances, a need remains for cost-effective wound treatments that 1) require less frequent changing; 2) provide an adequate moist environment; 3) absorb exudate; 4) prevent leakage onto periwound skin; and 5) do not adhere to or damage healing tissues. A new wound care system called the Sepaderm Wound Management System (Aalnex, Inc., Irvine, CA) was specifically engineered to incorporate these desirable properties. OTApligra Od It is composed of three distinct components: 1) an adhesive circular-frame support cushion made of an ultra-soft, closed-cell, nonabsorptive polyolefin foam that is biologically fluid-resistant; 2) an exudate wicking strip that surrounds the outer wound edge and acts as a protective barrier against exudate overflow onto the periwound area, which also transfers exudate away from the wound and upward to the third part of the system (the reservoir); and 3) a reservoir above the wound surface for isolation of absorbed exudates and to minimize any contact with the healing epithelium and granulation tissue in order to prevent damage. Additionally, the system is completely covered with a low-friction, velvet style, breathable, polyurethane membrane that maintains a physiologic moisture vapor transfer rate and also func- DO NOT Vol. 22, No. 10 October

2 D252D252 DO Figure 1. The Sepaderm Wound Management System. Figure 2. Healing of lower left leg burn wound with the use of Sepaderm system. Wound closure was 19% on day 7, 66% on day 14 and 100% by week 11. tions as a bacterial barrier (Figure 1). A prospective, ran- daily dressing changes. Seventy-eight days later, the domized, double-blind, clinical trial would provide the wound had decreased to 22.1 cm 2 (69% decrease) with best level of evidence regarding clinical efficacy of this moderate exudation and robust granulation. Treatment new system. This preliminary study reports three e cases of the Sepaderm system was then initiated (defined as three different wound types using the Sepaderm erm system 0) and was changed every 3 4 days with no noted without parallel controls or comparative treatments. additional pain. Healing progressed with continued moderate exudation, minimal maceration, and robust granulation (Figures 2, 3). The time to 50% wound closure was Case Reports Case 1: A 55-year-old white man (Patient 1) had achieved 12 days following the initiation of Sepaderm lower leg burn wound measuring 72 cm 2 leftd a left. He was treated DUwith DUday treatment (Figure 3). After nearly 7 weeks of Sepaderm with Mesalt dressing (Mölnlycke, Norcross, GA) with treatment, the wound was nearly 90% closed and was 3.DO Figure 3. Percent wound healing: A) prior to Sepaderm system and B) with the use of Sepaderm system. 252 WOUNDS reated NOT erupli

3 DO Table 1. Sepaderm treatment produced initial healing rates above the healing-predictive initial healing rate of 0.1 cm/week. Initial healing (cm/week)at rates (cm/week) Patient 1 Patient 2 Patient 3 (Burn (Surgical (Venous wound) excision) ulcer)* 1 Week NA 2 Weeks Weeks Weeks NA NA 0.13 *Nonhealing ulcer prior to Sepaderm treatment Figure 4. Healing of surgical excision in the scapular availableli NA = not available muscle area with the use of Sepaderm system. Wound closure was 44% on day 6, 48% on day 9 and was at day 16 (Figure 3). Sepaderm treatment was discontin- assessed as completely healed by day 28. ued at day 17 after 80% of the wound had closed and was then transitioned to standard dressings (Normlgel, Mölnlycke) and covered with Mepilex border dressing. The wound healed completely by day 28. Case 3: A 77-year-old African American man (Patient had a chronic venous leg ulcer on the lower left leg failed to show any closure after 8 months of prior treatments, which included compression wraps, various dressings, and Apligraf. The wound measured 2.8 cm 2 with robust granulation and a small amount of serosanguinous exudate. The site was cleaned with soap and DU3) DUthat water before the Sepaderm system treatment along with compression was initiated. The wound was not painful and it began to heal within two weeks (Figure 5). Healing accelerated and continued with normal periwound tissue and no pain (Figures 3 and 5). The wound reached Figure 5. Healing of left lower leg venous ulcer with the 50% closure at 31 days (Figure 3) and was considered use of Sepaderm system. Wound closure was 13% on day 14, 73% on day 31, and was assessed as healed completely after 66 days. completely healed by day 66. The healing rate for all three patients in this study reached levels that would predict the likelihood of complete healing for these wounds (Table 1). Patients 1 and then transitioned to standard dressings [Mesalt covered with Mepilex border dressing (Mölnlycke)]. The wound 2 had healing rates of 0.6 and 1.0 cm/week after 1 week completely closed 4 weeks later. of treatment, respectively. Patient 3 (initially a nonhealing Case 2: AfricN an A 67-year-old African American man (Patient venous ulcer) reached a healing rate of 0.15 cm/week 2) had surgical excision of an infected cyst in the scapular muscle area measuring 21 cm 2. He was treated with after 2 weeks of Sepaderm treatment. Mesalt dressing with daily changing. After 4 weeks, 53% Discussion of the wound had healed (9.9 cm 2 remaining). Defining this point as day 0, a 16-day treatment with Sepaderm sys- tem was then initiated. The system was changed every 3 4 days. Similar to Patient 1, wound healing continued to improve with the use of Sepaderm and reached near- ly 50% closure at day 9 (Figures 3 and 4) and 80% closure Newer wound dressings such as collagen/oxidized regenerated cellulose, negative pressure dressings, biological extracellular matrices, and silver alginate wound dressings, have been introduced with mixed results. For example, in randomized controlled trials, a collagen/oxidized regenerated cellulose dressing did not yield signif- NO OT uringnot DUPLI LIC ICAT ATE Vol. 22, No. 10 October

4 D254D254 DO icantly better outcomes opposed to the standard treatment of moistened gauze, 3 a negative pressure dressing was not significantly better than a static pressure dressing in skin graft healing of the radial forearm free flap donor site, 4 and a silver alginate wound dressing was not significantly better than a standard alginate dressing. 5 Therefore, there is a continuing medical need for dient and has no continuous, direct contact with the wound. The mechanism of action of this device cannot be completely defined at this time; however, rapid and complete wound closure was shown in these three reported case histories. s. Sepaderm s ability to promote wound healing may be due to multiple factors. Sepaderm satisfies the Guidelines ines recommendation for dressings in improved wound dressings that promote wound healing. the treatment of venous ulcers, 8 diabetic ulcers, 9 and The Sepaderm wound management system was selected to treat three different wound types based on its ability to remove excess exudate from the wound bed, which limits exudate leakage onto periwound tissue while maintaining a moist environment for the wound bed, and its ease of application. Its ability to promote wound healing in previously treated wounds, including a chronic venous ulcer that failed to heal following all previous pressure ulcers 10 for: maintaining a moist wound-healing environment; facilitating continued moisture; managing wound exudate and protecting the periulcer tissue; staying in place, minimizing sheer and friction, and not causing additional ditional tissue damage. In addition, its excellent exudate absorption capacity that limits exudate leakage onto periwound tissue and prevents excessive moisture as well as various enzymes and factors in the exudate treatments, a burn wound, and a fresh surgical from building up in the wound and on periwound tissue wound was assessed. Complete wound closure of chron- probably prevented maceration, delay in healing, ic, nonhealing venous leg ulcers has been demonstrated ted increase in pain/discomfort, and expansion of the wound if 50% wound closure is achieved in less than 60 days size in these patients. Chronic wound exudate contains (Michael L. Sabolinski, personal communication, January an imbalance of metalloproteinases and has been shown 2010). Both the acute, surgical, and the burn wound had decrease the proliferation of cells including keratinocytes, fibroblasts, and endothelial cells similar healing rates reaching 50% closure at days 9 and 11, respectively. In Case 3, where the chronic venous Additionally, the exudate contains substances that may ulcer had failed to heal using best care treatment prior bind essential growth factors, complicating the healing the use of the Sepaderm system, reached 50% closure atd of wounds. 14 Unlike other wound treatments, the day 31 subsequent to the use of the Sepaderm system.d system. Sepaderm system avoids direct contact with the wound Falanga and Sabolinski 6 and Sabolinski et al 7 had deter- DUto DUatinoc bed. All these features likely contribute to promoting mined that within the first 4 weeks an initial healing rate wound healing. of 0.1 cm/week and cm/week would predict complete healing of venous ulcers and diabetic foot ulcers, respectively. All three wounds treated with Sepaderm achieved healing rates above these lower limits that predict complete wound healing (average of 1.1 While our clinical experience with the Sepaderm system is limited, including single cases of three different wound types with no controls or comparative treatments, a number of advantages with its use are apparent. The effectiveness of Sepaderm appears to be due to its cm/week for both burn and surgical wounds and average ability to stay intact for several days and its capacity to of 0.13 cm/week for the venous ulcer). It is important to absorb large amounts of exudate (45 ml 275 ml based note that with the use of the Sepaderm system, the on its size) compared to daily or more frequent changes wound edges were not disrupted by a dressing or at the of standard dressings. Sepaderm has been shown to be time of dressing sing change, and the wound edges were free easy to use and maintain, and patients report less pain of contact disturbances. ThereN There was no wound, or periwound infection n or inflamn when compared to other treatments, allowing them to inflammation, and a permissive participate in changing their own dressings this saves wound-healing environment was achieved. All three the patient and managed care company time and expenses wounds healed completely with normal periwound tissue and minimal maceration during the entire healing process and the healed skin returned to normal pigmen- tation. The Sepaderm system stayed in place for the dura- tion between changing and there was no exudate leak- age. Sepaderm does not contain any medically active ingre- because of the decrease in clinic visits. Thus, the Sepaderm system also satisfies the last Guideline recommendation for dressings regarding cost effective treatment of venous ulcers. 8 The system may have demonstrated cost effectiveness primarily because of an increased rate of healing and increased incidence of complete wound closure. Additionally, the Sepaderm sys- onmn NOT 254 WOUNDS deted

5 DO tem can stay in place for multiple days requiring fewer visits to the clinic, and fewer telephone calls to healthcare treatment of venous ulcers. Wound Repair Regen. 2006;14(6): providers. Most importantly, the Sepaderm system demonstrates the ability to achieve complete wound closure in nonhealing wounds. 9. Steed DL, Attinger C, Colaizzi T, et al. Guidelines for the treatment of diabetic ulcers. Wound Repair Regen. 2006;14(6): Conclusion In this case series, each of the three wound types 10. Whitney J, Phillips L, Aslam R. Guidelines for the treatment of pressure ulcers. Wound Repair Regen. 2006;14(6): (burn, surgical excision, and a non-healing venous ulcer) treated with the Sepaderm System showed excellent healing results. The treatment was well accepted by both 11. Bucalo B, Eaglstein WH, Falanga V. Inhibition of cell proliferation by chronic wound fluid. Wound Repair Regen. 1993;1(13): (13): patients and clinicians. It was easy to use, could be left in place for extended periods, managed exudate without 12. Park HY, Shon K, Phillips T. The effect of heat on the inhibitory effects of chronic wound fluid on fibroblasts leakage, maintained a moist wound environment, and did in vitro. WOUNDS ;10(6): not allow exudate to pool on the treated site. Wound 13. Tomic-Canic M, Ågren MS, Alvarez O. Epidermal repair healing improved and led to complete closure in a burn and the chronic wound. In: Rovee DT, Maibach HI, eds. wound, surgical excision, and a venous ulcer. The The Epidermis in Wound Healing. New York, NY: CRC authors limited experience with Sepaderm in reducing Press LLC; 2004: the need for multiple dressing changes, return visits or 14. Falanga V, Eaglstein WH. The trap hypothesis of venous calls to address exudate leakage, pain, or discomfort, and ulceration. Lancet. 1993;341(8851): the successful treatment of a long-term venous ulcer will need to be substantiated in larger studies. Further clinical trials are underway. UPPress References 1. Rizzi SC, Upton Z, Bott K, Dargaville advancesd TR. Recent advances in dermal wound healing: biomedical device approaches. Expert Rev Med Devices. 2010;7(1): Falanga V, Sabolinski M. A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen ;7(4): Veves A, Sheehan P, Pham HT. A randomized, controlled trial of Promogran (a collagen/oxidized regenerated cellulose dressing) vs standard treatment in the management of diabetic foot ulcers. Arch Surg ;137(7): Chio EG, Agrawal A. A randomized, prospective, controlled study of forearm donor site healing when using a vacuum dressing. Otolaryngol Head Neck Surg. 2010;142(2): Trial C, Darbas LavigneN H, Lavigne JP, et al. Assessment of the antimicrobial effectivenn effectiveness of a new silver alginate wound dressing: a RCT. J Wound Care. 2010;19(1): Falanga V, Sabolinski ML. Prognostic factors for healing of venous ulcers. WOUNDS. 2000;12(5 Suppl A):42A 46A. 7. Sabolinski M, Falanga V, Giovino K, Toole T. Mean healing rates at 4 weeks can predict complete wound closure of diabetic foot ulcers. J Soc Invest Dermatol. 2001;117: Robson RC, Cooper DM, Aslam R, et al. Guidelines for the RCTN NOT approaches.d Vol. 22, No. 10 October