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| Debridement Clinical Studies |
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Wound Bed Preparation: The Science Behind the Removal of Barriers to Healing Journal: Wounds (2003) Authors: Stuart Enoch, MBBS, MRCSEd, MRCS (Eng); Keith Harding, MB ChB, MRCGP, FRCS Abstract: Wound healing involves a well-orchestrated, complex process leading to repair of injured tissues. However, chronic wounds do not follow the normal pattern of repair. This is due to underlying physiological problems associated with their development, which unless corrected would continue to cause wound deterioration. The key to effective wound care lies in a combination of three approaches: treatment of underlying medical problems, assessment and treatment of local wound bed, and effective management of any patient-centered concerns. An essential component of this recommended approach is restoration of healthy granulation tissue in the wound bed. Wound bed preparation brings a number of existing procedures, including debridement, treatment of infection, and management of exudate levels, together into a systematic approach to help restore the chronic wound bed environment. The aim of wound bed preparation is to remove the barriers to healing and initiate the repair process. This review explores the scientific rationale behind this concept and examines how wound bed preparation offers healthcare professionals an improved paradigm for the treatment of chronic wounds. By implementing wound bed preparation, the formation of healthy granulation tissue will be optimized and the efficiency of biotechnological therapies improved, which would ultimately reduce the time to wound closure. 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 Debridement: Rationale and Therapeutic Options Journal: Wounds Supplement (2002) Authors: Heather Zacur, BS; Robert S. Kirsner, MD Abstract: Debridement is commonly defined as the process of removing necrotic, devitalized tissue and foreign material from a wound. The presence of necrotic tissue within a wound may impair wound repair processes by stimulating inflammation and delaying granulation and epithelialization. However, the above definition of debridement may not tell the whole story. Debridement may additionally remove senescent cells from the wound bed and nonmigratory cells from the ulcer edge and also remove excessive or abnormal bacteria; all of which may allow for improved availability of growth factors. This supplement will review the rationale for debridement, existing clinical data supporting debridement, and the various debridement options available. Wound Bed Preparation and the Role of Enzymes: A Case for Multiple Actions of Therapeutic Agents Journal: Wounds (2002) Authors: Vincent Falanga, MD Abstract: Wound bed preparation as a concept is revolutionizing the way we approach chronic wounds. We define it as the global management of wounds to accelerate endogenous healing or to facilitate the effectiveness of therapeutic products. As a result of this more encompassing way of approaching wounds, a number of new concepts are emerging. We now talk about the possibility that a cellular burden, comprising phenotypically abnormal cells, exists in chronic wounds and needs to be removed or corrected. We have come to recognize the deleterious effects of excessive exudate, which breaks down extracellular matrix material and blocks the effectiveness of new forms of therapy, including growth factors and bioengineered skin. We are becoming more cognizant of the pathophysiologic abnormalities of chronic wounds and of ways to correct them. We have also come to recognize that chronic wounds may be in need of constant or more steadystate debridement. Hence, the concept of maintenance debridement may need to be tested. In this review of wound bed preparation, we now propose that this more comprehensive approach to wounds will allow us to explore new therapeutic benefits of existing treatment modalities. As a proof of principle, we have examined the potential role of enzymatic debridement in other aspects of wound bed preparation. The hope is that in the context of wound bed preparation we will begin to reevaluate commonly used treatments for opportunities to explore their other properties and therapeutic benefits. 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. Preparing the Wound Bed-Debridement, Bacterial Balance, and Moisture Balance Journal: Ostomy Wound Management (2000) Authors: R. Gary Sibbald, MD, FRCPC; Diane Williamson, MB, MRCP(UK); Heather L. Orsted, RN, BN, ET; Karen Campbell, RN, MScN; David Keast,MD, CCFP; Diane Krasner, PhD, RN,CWOCN, CWS, FAAN; and Debra Sibbald, BScPhm Abstract: Successful diagnosis and treatment of patients with chronic wounds involve holistic care and a team approach. The integration of the work of an interdisciplinary care team that includes doctors, nurses, and allied health professionals with the patient, family, significant others, and caregivers offers an optimal formula for achieving wound resolution. Such an approach challenges practitioners and everyone participating in wound care to integrate data and information that arise from a number of sources and mitigating factors. In this article, the authors define the changing paradigm that links treatment of the cause and focuses on three components of local wound care: debridement, wound-friendly moist interactive dressings, and bacterial balance. The authors demonstrate that the treatment of chronic wounds can be accomplished through a series of recommendations and rationales based on the literature and their experience. These recommendations lay the groundwork for thorough assessment and evaluation of the 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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