Cymetra: A Treatment Option for Refractory Ulcers
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C hronic wounds are caused by a variety of etiologies, including diabetic neuropathy, venous and/or arterial insufficiency, and prolonged pressure.1 In addition to significant morbidity and both financial and emotional costs, chronic wounds have been associated with an increased risk of osteomyelitis and limb amputation and increased mortality.2 At present, despite addressing the underlying pathophysiology of the wound and employing adjuvant therapies, such as growth factors and tissue-engineered skin, a need exists for additional options in the therapeutic arsenal. In this article, the authors report their experience with Cymetra® (LifeCell Corporation, Branchberg, New Jersey) as an adjuvant in the treatment of a variety of chronic wounds.
Cymetra is a micronized, decellularized dermal matrix product developed as a filler substance for cosmetic use. Effective enhancement of aging lips with its use has been reported.3 Cymetra is approved by the US Food and Drug Administration (FDA) as a human tissue for transplantation for the repair or replacement of damaged or inadequate integumental tissues. It is an injectable, micronized form of AlloDerm® (LifeCell Corporation), a nonantigenic, allogeneic, acellular dermal matrix with an intact basement membrane. Cymetra has shown excellent tissue biocompatibility, a low rate of resorption, and no tissue reactivity.4 Recently, it has been reported to be an effective adjuvant therapy in two patients with recalcitrant sinus tracts.5 Based on these findings, the authors hypothesize that injection of Cymetra into a wound or ulcer may similarly expedite healing, leading to wound closure. In this article, the authors report results of off-label use of Cymetra in 13 patients with refractory ulcers.
All patients who received Cymetra were identified from the CURE Wound Care Center at the University of Miami, Miami, Florida. A total of 13 patients were treated. A retrospective chart review of these 13 patients was performed, extracting data on patient demographics, comorbidities, ulcer history, prior treatments, and response to Cymetra.
Patients. Thirteen patients (9 women and 4 men) were identified. Their mean age at treatment onset was 68 years. Wound types were pyoderma gangrenosum (PG) (6), pressure ulcer (2), post-operative ulcer (2), venous ulcer (1), eosinophilic fasciitis (1), and livedo vasculitis ulcer (1). The ulcers had a median size of 2.4cm2 prior to treatment. The mean wound duration prior to treatment was 6.3 months with a standard deviation of +/- 6.25 months.
Treatment. Prior to treatment with Cymetra, all 13 wounds received multiple therapies, including compression, occlusive dressings, topical antibiotics and steroids, and skin grafting with autologous or tissue-engineered skin (Table 1). The patients also received systemic medications, such as antibiotics, steroids, and etanercept. Cymetra either was added to or replaced some of the patients’ previous wound care regimen.
Cymetra was prepared according to the directions from LifeCell Corporation: 330mg of the dehydrated product was rehydrated with one-percent lidocaine in a syringe prior to instillation with an 18-gauge needle. Patients received 1–4mL of Cymetra at dosing intervals ranging from weekly to monthly, depending on ulcer size and response to therapy. Patients with ulcers having maximum diameters of less than 2cm were given an initial injection of 1cc. This dose was maintained or increased according to response. In some cases, other wound therapies were continued in combination with Cymetra treatment, including routine dressing changes, adequate debridement, infection control, compression therapy, and offloading. All other wound treatments used are listed in Table 1.
Ulcer response to Cymetra. Ulcer response to Cymetra is summarized in Table 2.
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