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| ACCUZYME® Ointment Clinical Studies | |
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Accuzyme® Papain-Urea Debriding Ointment: A Historical Review Journal: Wounds Supplement (2003) Authors: J. Barry Wright, PhD; Lei Shi, PhD Abstract: Debriding a wound may be a crucial first step in healing for some patients. Current best practices recommend the use of one or more debridement modalities as appropriate for a particular wound. This article provides a historical review of debridement. It also reviews the five major types of debridement (autolytic, enzymatic, mechanical, sharp, and biological), focusing on the papain-urea debriding ointment, Accuzyme® (Healthpoint, Ltd., Ft. Worth , Texas ). A Prospective, Randomized, Comparative Study of Collagenase and Papain-Urea for Pressure Ulcer Debridement Journal: Wounds (2002) Authors: Oscar M. Alvarez, PhD; Adolfo Fernandez-Obregon, MD; Roisin S. Rogers, RN, MSN,CWCN; Louisa Bergamo, RN; John Masso, RN, MSN; Marion Black, RN, MSN Abstract: Objective: To evaluate and compare the ability of two commercial chemical debridement ointments to effectively remove devitalized tissue and promote granulation in pressure ulcers requiring debridement. One of the test agents was an enzymatic formulation (collagenase) and the other a formulation of papain and urea. Design: This study was a prospective, randomized, parallel group, tri-center, open-label, clinical trial with a two-week screening period to stabilize the wound and an evaluation period of four weeks induration. Setting: The patients who participated in the trial were nursing home residents in northern New Jersey . Participants: Twenty eight patients were randomly assigned to ulcer treatment with either collagenase debriding ointment (n = 12) or papain-urea debriding ointment (n = 14). Two patients dropped out early due to unrelated treatment issues. Measurements: Wounds were treated once daily until complete debridement or four weeks. The major outcome of nonviable (necrotic) tissue reduction (determined by planimetry) was assessed weekly by intention to treat. The amount of nonviable tissue, degree of wound granulation, and overall wound response were evaluated weekly using a visual scale. Wound area measurements were performed by morphometric analysis of perimeter tracings. Results: The papain-urea debriding ointment was significantly more effective (p < 0.0167) than the collagenase ointment in reducing the amount of necrotic tissue at each of the three prospectively determined weekly evaluations. Development of granulation tissue in wounds treated with papain-urea was significantly enhanced as compared to wounds treated with collagenase. Epithelialization generally correlated with the development of a granulating wound bed as determined by visual assessment. However, the general increase in the amount of epithelial tissue associated with the papain-urea-treated wounds did not predict a significantly different rate of reduction in the actual wound area. Conclusion: This study evaluated the effects of papain-urea and collagenase on pressure ulcer debridement in a relatively small population (26 patients) of nursing home residents. Although the papain-urea debriding ointment exhibited some clear advantages over the collagenase debriding ointment, a strong scientific conclusion cannot be made The Effects of Active Ingredients of Standard Debriding Agents- Papain and Collagenase- on Digestion of Native and Denatured Collagenous Substrates, Fibrin and Elastin Journal: Wounds (2001) Authors: Patricia A. Hebda, PhD; Chia-Yee Lo, MS Abstract: Debridement of necrotic eschar from wounds can be accomplished with the application of proteolytic enzyme formulations. However, a clear understanding of the biochemical activities of the enzymatic agents is essential for achieving effective wound debridement. This report describes the in-vitro evaluation of the active ingredients of several commercial debriding agents. Collagenase and papain/urea were tested in standard enzymatic assays for their ability to digest several substrates found in various types of wound eschars and chronic ulcers. Both showed activity with denatured and, to a lesser extent, native collagenous substrates. Papain/urea effectively digested fibrin but had only slight activity with elastin. Collagenase slightly digested fibrin but was active in digesting elastin. These results indicate that the biochemical activities vary among the active ingredients of topical debriding agents, and this finding should be a consideration in selecting the best treatment for each type of wound. Development and Use of a Quantitative Method to Evaluate the Action of Enzymatic Wound Debriding Agents in vitro Journal: Wounds (1998) Authors: David Hobson, PhD, DABT; Eric White, BS; Larry Anderson, BS; Lance Lira, BS Abstract: Wounds considered for enzymatic debridement encompass a variety of fluid content, microbial flora, pharmaceutical treatment, and pH conditions that may affect the efficacy of an enzymatic debriding agent. Development of products for use as debriding agents or for use in conjunction with debriding agents requires a quantitative procedure to rapidly evaluate different product formulations for their optimal effects on debridement efficacy under a variety of tissue conditions that cannot be controlled adequately when conducting in vivo clinical evaluations. A new, quantitative, in-vitro method to evaluate the action of enzymatic debriding agents uses porcine skin and muscle tissue as substrates. The method utilizes an automated Franz-type in-vitro diffusion cell system for controlled exposure of tissues to debriding agents and sample collection for quantitative analysis of enzymatic digestion product release; e.g., protein, peptides, and amino acids. This article describes 1) setup and operation of the system; and 2) the practical use of the method as demonstrated by its ability to rapidly assess quantitative differences in the action of different enzymatic debriding agent formulations on nonviable skin tissue. Evaluation of the Efficacy of Enzymatic Debriding Agents for Removal of Necrotic Tissue and Promotion of Healing in Porcine Skin Wounds Journal: Wounds (1998) Authors: Patricia A. Hebda, PhD; Kevin J. Flynn, MD; Joseph E. Dohar, MD, MS Abstract: Four commercial enzymatic debriding ointments were evaluated for effective necrotic tissue digestion and promotion of healing. Multiple wounds of three types were made in porcine skin: full thickness excisions, partial thickness burns and partial thickness excisions with chemical ablation. Treatments were: 1) Papain with urea, a denaturing agent, and chlorophyllin copper complex, a healing promoter that counteracts the hemagglutinating and inflammatory properties of protein digestion and stimulates healthy granulation tissue; 2) Papain/urea; 3) Collagenase (bacterial); 4) Fibrinolysin/Desoxyribonuclease (DNase); and 5) Untreated control. Wounds were treated daily on Days 1-3 and evaluated on Days 4 and 10. Clinical evaluation included wound appearance and tissue solubilization. Histologic evaluation included necrotic tissue, clot or crust, re-epithelialization, inflammation, granulation tissue formation and global healing. For full thickness excisions with a fibrinous crust, papain/urea treatments produced partial digestion on Day 4, with healing comparable to the control on Day 10; collagenase and fibrinolysin/DNase produced less debridement on Day 4, and showed less re-epithelialization on Day 10. For wounds with necrotic eschar induced by heat or chemical insult, papain/urea ointments were most effective in debridement and promotion of healing, collagenase ointment was somewhat effective, while fibrinolysin/DNase ointment had no effect. Papain/urea treatments produced the best outcome overall for debridement and wound healing.
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