A bilayered living skin construct (APLIGRAF®) accelerates complete closure of hard‐to‐heal venous ulcers

The efficacy of a bilayered, living skin construct (APLIGRAF®[Graftskin]) was evaluated in patients (n = 120) with hard‐ to‐heal venous leg ulcers of greater than 1 year's duration. The study was prospective, randomized, and controlled. Patients received Graftskin plus compression therapy, or standard compression therapy (active control). Patients were evaluated for frequency and time to complete (100%) wound closure. Treatment with Graftskin was significantly more effective than active control in the percentage of patients healed by 6 months (47% vs. 19%; p < 0.005) and the median time to complete wound closure (p < 0.005). Analysis with multivariate regression methods, adjusting for factors generally thought to influence wound healing (duration, baseline area, depth, location, fibrinous wound bed, and infection), showed that patients treated with Graftskin were twice as likely to achieve complete wound closure by 6 months (p < 0.005), and over 60% more effective in achieving wound closure than active control (p < 0.01). These data indicate that Graftskin is an effective treatment for venous ulcers of greater than 1 year's duration.

[1]  A. Falabella,et al.  Dermal fibroblasts from venous ulcers are unresponsive to the action of transforming growth factor-beta 1. , 1997, Journal of dermatological science.

[2]  Fitzpatrick Je.  Stasis ulcers: update on a common geriatric problem. , 1989 .

[3]  A. Charlett,et al.  Venous leg ulcers: a prognostic index to predict time to healing. , 1992, BMJ.

[4]  C. Doré,et al.  Leg ulcers: Epidemiology and aetiology , 1986, The British journal of surgery.

[5]  D. Margolis,et al.  Management of chronic venous leg ulcers: a literature-guided approach. , 1994, Clinics in dermatology.

[6]  Richard F. Gunst,et al.  Applied Regression Analysis , 1999, Technometrics.

[7]  E Bell,et al.  Recipes for reconstituting skin. , 1991, Journal of biomechanical engineering.

[8]  L. E. Reichardt.  Venous ulceration. , 1983, British medical journal.

[9]  B. Stanton,et al.  A study of the impact of leg ulcers on quality of life: financial, social, and psychologic implications. , 1994, Journal of the American Academy of Dermatology.

[10]  J. Fitzpatrick.  Stasis ulcers: update on a common geriatric problem. , 1989, Geriatrics.

[11]  N. Breslow,et al.  Statistical methods in cancer research. Vol. 1. The analysis of case-control studies. , 1981 .

[12]  J. Guilhou,et al.  [Rapid healing of venous ulcers and lack of clinical rejection with an allogeneic cultured human skin equivalent]. , 1999, Annales de dermatologie et de venereologie.

[13]  N. Parenteau,et al.  Development of a bilayered living skin construct for clinical applications , 1994, Biotechnology and bioengineering.

[14]  S R Baker,et al.  Epidemiology of chronic venous ulcers , 1991, The British journal of surgery.

[15]  E. Bell,et al.  The commercial use of cultivated human cells. , 1990, Transplantation proceedings.

[16]  M. Kerstein.  The non-healing leg ulcer: peripheral vascular disease, chronic venous insufficiency, and ischemic vasculitis. , 1996, Ostomy/wound management.

[17]  D. Krasner,et al.  Chronic Wound Care: A Clinical Source Book for Healthcare Professionals , 1990 .

[18]  J. Menzoian,et al.  Reduced growth of dermal fibroblasts from chronic venous ulcers can be stimulated with growth factors. , 1997, Journal of vascular surgery.

[19]  S. Rivlin.  “Venous Ulcers” , 1967, BMJ.

[20]  M. Kerstein.  The scientific basis of healing. , 1997, Advances in wound care : the journal for prevention and healing.

[21]  J. Capeheart.  Chronic venous insufficiency: a focus on prevention of venous ulceration. , 1996, Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society.

[22]  J. Bergan,et al.  Chronic venous ulcer , 1997, BMJ.

[23]  J. Olin,et al.  Medical costs of treating venous stasis ulcers: evidence from a retrospective cohort study , 1999, Vascular medicine.

[24]  J J Dale,et al.  Chronic ulcer of the leg: clinical history. , 1987, British medical journal.

[25]  J. Dover,et al.  Leg ulcers. , 1991, Journal of the American Academy of Dermatology.

[26]  W. Eaglstein,et al.  A Composite Skin Substitute (Graftskin) for Surgical Wounds: A Clinical Experience , 1995, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[27]  N. Parenteau,et al.  Epidermis generated in vitro: practical considerations and applications , 1991, Journal of cellular biochemistry.

[28]  M. Plummer,et al.  International agency for research on cancer. , 2020, Archives of pathology.

[29]  M. Auletta,et al.  Cultured skin as a 'smart material' for healing wounds: experience in venous ulcers. , 1996, Biomaterials.