Wound Bed Preparation With a Dermal Substitute (Hyalomatrix® PA) Facilitates Re-epithelialization and Healing: Results of a Multicenter, Prospective, Observational Study on Complex Chronic Ulcers (The FAST Study).

The FAST study evaluated the performance and safety of Hyalomatrix® PA (a dermal substitute) in the treatment of chronic wounds of different etiology. This was a multicenter, prospective, observational study involving 70 Italian centers and 262 elderly patients. Patients were observed from the start of treatment with a dermal substitute (Hyalomatrix® PA [HPA]) until healthy dermal tissue suitable for a thin autograft was visible or until the growth of new epithelium from the wound edge was reported. Tracking the wound edge advancement was used to assess the dermal substitute's performance. The main endpoint was the reduction in threshold area (≥ 10%) of the ulcer. Treated ulcers were characterized as follows: 46% vascular, 25% diabetic foot, 12% traumatic wounds, 2% pressure ulcers and 15% other. Re-epithelization (≥ 10%) was achieved in 83% of ulcers in a median time of 16 days. Twenty-six percent (26%) of wounds achieved 75% re-epithelization within the 60-day follow-up period using only HPA treatment. A follow-up showed that 84% of ulcers achieved complete re-epithelialization by secondary intention. These findings indicate that HPA is a safe and effective dermal substitute. The results show that the re-epithelization process following HPA treatment is independent upon etiology, area, and depth of the ulcer, and treatment is more effective on acute ulcer formation.

[1]  G. Gravante,et al.  Hyalomatrix PA in Burn Care Practice: Results From a National Retrospective Survey, 2005 to 2006 , 2010, Annals of plastic surgery.

[2]  M. Romanelli,et al.  Measuring wound outcomes. , 2007, Wounds : a compendium of clinical research and practice.

[3]  G. Gravante,et al.  The Use of Hyalomatrix PA in the Treatment of Deep Partial-Thickness Burns , 2007, Journal of burn care & research : official publication of the American Burn Association.

[4]  I. Leigh,et al.  A comparison of tissue-engineered hyaluronic acid dermal matrices in a human wound model. , 2006, Tissue engineering.

[5]  C. Attinger,et al.  Clinical Approach to Wounds: Débridement and Wound Bed Preparation Including the Use of Dressings and Wound-Healing Adjuvants , 2006, Plastic and reconstructive surgery.

[6]  M. Costagliola,et al.  Second-degree burns: a comparative, multicenter, randomized trial of hyaluronic acid plus silver sulfadiazine vs. silver sulfadiazine alone , 2005, Current medical research and opinion.

[7]  D. Margolis,et al.  Healing diabetic neuropathic foot ulcers: are we getting better? , 2005, Diabetic medicine : a journal of the British Diabetic Association.

[8]  Jesse A Berlin,et al.  Diabetic neuropathic foot ulcers: predicting which ones will not heal. , 2003, The American journal of medicine.

[9]  Alan L Miller,et al.  Nutritional support for wound healing. , 2003, Alternative medicine review : a journal of clinical therapeutic.

[10]  M Flanagan,et al.  Wound measurement: can it help us to monitor progression to healing? , 2003, Journal of wound care.

[11]  Jesse A Berlin,et al.  Diabetic neuropathic foot ulcers: the association of wound size, wound duration, and wound grade on healing. , 2002, Diabetes care.

[12]  W. Eaglstein,et al.  Moist Wound Healing with Occlusive Dressings: A Clinical Focus , 2001, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[13]  J. Banyard,et al.  Differential response of fetal and adult fibroblasts to cytokines: cell migration and hyaluronan synthesis. , 1997, Development.

[14]  I. Ellis,et al.  Differential effects of TGF-beta1 on hyaluronan synthesis by fetal and adult skin fibroblasts: implications for cell migration and wound healing. , 1996, Experimental cell research.

[15]  Shant Kumar,et al.  Angiogenic oligosaccharides of hyaluronan enhance the production of collagens by endothelial cells. , 1993, Journal of cell science.

[16]  C. McCollum,et al.  Sequential changes in histologic pattern and extracellular matrix deposition during the healing of chronic venous ulcers. , 1992, The American journal of pathology.

[17]  A. Schor,et al.  Antagonistic effects of TGF-beta 1 and MSF on fibroblast migration and hyaluronic acid synthesis. Possible implications for dermal wound healing. , 1992, Journal of cell science.

[18]  J J Dale,et al.  Chronic ulceration of the leg: extent of the problem and provision of care. , 1985, British medical journal.

[19]  I. Hampson,et al.  Angiogenesis induced by degradation products of hyaluronic acid. , 1985, Science.

[20]  W. Hickerson,et al.  Beneficial actions of exogenous hyaluronic acid on wound healing. , 1991, Surgery.

[21]  P. Weigel,et al.  The role of hyaluronic acid in inflammation and wound healing. , 1988, International journal of tissue reactions.