Cymetra: A Treatment Option for Refractory Ulcers
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Nine of the 13 patients’ ulcers healed after Cymetra treatment. In eight of the nine patients, the ulcers remained healed for at least three months; the ulcer in patient 11 with peristomal PG reopened after six months and was successfully retreated with conservative wound care. The mean time to healing in the nine patients successfully treated with Cymetra was 3.7 months. Four patients’ ulcers failed to heal. The etiologies of the four nonhealing ulcers were pressure (2), eosinophilic fasciitis (1), and a stump ulcer (1). No adverse effects of Cymetra treatments were observed or reported.
Chronic wounds affect more than 6.5 million patients each year and cause significant morbidity and impaired quality of life.6 Diabetes, venous or arterial insufficiency, and chronic pressure are the most common etiologies of poorly healing wounds in the US. Approximately 10 percent of leg ulcers are due to atypical causes including inflammatory conditions, such as PG, which can cause refractory ulcers.7
During the past decade, biologically active wound interventions, such as therapeutic growth factor proteins and tissue-engineered products, have become available. In 1997, recombinant human platelet-derived growth factor-BB (rhPDGF-BB, becaplermin) became the first therapeutic growth factor to receive FDA approval for healing chronic wounds.8 Similarly, tissue-engineered products, such as Apligraf® (Organogenesis, Canton, Massachusetts) and Dermagraft (Smith & Nephew, Largo, Florida), have been shown to stimulate healing, presumably through the production of growth factors in the wound bed and by providing a framework for the ingrowth of cells.9
Cymetra is a micronized form of AlloDerm, an allogeneic acellular dermal matrix. AlloDerm provides a three-dimensional collagen scaffold that is likely to promote cellular migration and tissue integration. Over time, this matrix is repopulated, and fibroblast infiltration has been confirmed by histology within one month.10 Moreover, its biologic nature provides AlloDerm less inclination toward infection, erosion, and rejection when compared with synthetic tissue replacement materials. In addition to serving as a filler for cosmetic use, there are recent reports suggesting the utility of AlloDerm to repair meningomyeloceles during neurosurgical reconstructions, increase gingival thickness in patients with buccal recession defects, and repair abdominal wall hernias.11–13
Cymetra is the first available injectable dermal matrix. Cymetra maintains the ultrastructure of the dermis yet easily passes through an 18-gauge needle. These properties lend Cymetra significant advantages in ulcers that are deep or undermined and in sinus tracts. As a promoter of healing in recalcitrant sinus tracts, Cymetra has been recently reported in two patients, one of which had a sinus tract complicated by PG. Clinical studies to date describe no allergic or immunologic reactions to Cymetra.
In this article, the authors report the success of Cymetra in the treatment of chronic wounds. The authors treated 13 patients suffering from chronic ulcers with injections of Cymetra. The ulcers in nine of the 13 patients (69%) healed. These results are similar to those reported by Embil, et al., with the off-label use of becaplermin in which 57.5 percent of patients achieved complete healing of lower-extremity ulcers and also similar to the report by Harrison-Balestra, et al., in which 64 percent of ulcers healed with becaplermin.14,15 Although Patient 2 failed to heal, the wound showed a marked increase in granulation tissue and was prepared for the placement of V.A.C.® Therapy™ (KCI Inc., San Antonio, Texas). Similarly, there was an increase in granulation tissue in the stump ulcer of Patient 5, and she subsequently underwent a split-thickness skin graft.
1. Eaglstein WH, Falanga V. Chronic wounds. Surg Clin North Am 1997;77(3):689–700.
2. Phillips T, Stanton B, Provan A, Lew R. A study of the impact of leg ulcers on quality of life: Financial, social, and psychologic implications. J Am Acad Dermatol 1994;31(1):49–53.
3. Sclafani AP, Romo T III, Jacono AA. Rejuvenation of the aging lip with an injectable acellular dermal graft (Cymetra). Arch Facial Plast Surg 2002;4(4):252–7.
4. Homicz MR, Watson D. Review of injectable materials for soft tissue augmentation. Facial Plast Surg 2004;20(1):21–9.
5. Banta MN, Eaglstein WH, Kirsner RS. Healing of refractory sinus tracts by dermal matrix injection with Cymetra. Dermatol Surg 2003;29(8):863–6.
6. Takahashi PY, Kiemele LJ, Jones JP Jr. Wound care for elderly patients: Advances and clinical applications for practicing physicians. Mayo Clin Proc 2004;79(2):260–7.
7. Callen JP. Pyoderma gangrenosum. Lancet 1998;351(9102):581–5.
8. Weiman TJ. Efficacy and safety of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic venous ulcers: A pilot study. WOUNDS 2003;15(8):257–64.
9. Jiang WG, Harding KG. Enhancement of wound tissue expansion and angiogenesis by matrix-embedded fibroblast (Dermagraft), a role of hepatocyte growth factor/scatter factor. Int J Mol Med 1998;2:203–10.
10. Sclafani AP, Romo T III, Jacono AA, et al. Evaluation of acellular dermal graft in sheet (AlloDerm) and injectable (micronized AlloDerm) forms for soft tissue augmentation: Clinical observations and histological analysis. Arch Facial Plast Surg 2000;2:130–6.
11. Agag RL, Granick MS, Omidi M, Catrambone J, Benevenia J. Neurosurgical reconstruction with acellular cadaveric dermal matrix. Ann Plast Surg 2004;52(6):571–7.
12. Woodyard JG, Greenwell H, Hill M, et al. The clinical effect of acellular dermal matrix on gingival thickness and root coverage compared to coronally positioned flap alone. J Periodontol 2004;75(1):44–56.
13. Buinewicz B, Rosen B. Acellular cadaveric dermis (AlloDerm): A new alternative for abdominal hernia repair. Ann Plast Surg 2004;52(2):188–94.
14. Embil JM, Papp K, Sibbald G, et al. Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: An open-label clinical evaluation of efficacy. Wound Repair Regen 2000;8(3):162–8.
15. Harrison-Balestra C, Eaglstein WH, Falabella AF, Kirsner RS. Recombinant human platelet-derived growth factor for refractory nondiabetic ulcers: A retrospective series. Dermatol Surg 2002;28(8):755–60.