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Multimodal treatment of pyoderma gangrenosum
P3306
P3308
TRAPPING OF BACTERIA BY CADEXOMER BEADS IN VIVO AND IN VITRO Linda Zhou, MD, Janet Butmarc, Tatyana Yufit, MD, Boston UniversityeRoger Williams Medical Center, Providence, RI, United States; Vincent Falanga, MD, Department of Biochemistry, Boston University, Boston, MA, United States
MEASURING THE VELOCTY OF WOUND HEALING Vincent Li, MD, Angiogenesis Foundation, Cambridge, MA, United States
Slow-release antiseptics are increasingly being used in the treatment of exudative wounds with a high bacterial load. One such agent, cadexomer iodine, carries iodine (0.9% wt/wt) immobilized in beads of dextrin and epichlorhydrin and has been demonstrated to be highly effective in promoting healing of exudative wounds. We reported previously that cadexomer iodine lacks toxicity in vivo and in vitro, at least within a certain concentration range. Additionally, we also reported that, in vivo, bacteria can be found in the cadexomer beads. In this study, to test the hypothesis that cadexomer beads are capable of trapping bacteria, we used the vehicle cadexomer beads (without iodine) and exposed it to varying amounts of Escherichia coli in vitro. A number of experiments were performed, testing the optimal exposure time of bacteria to beads (up to 144 hours) and bacterial load in DMEM plus 10% FBS. In addition, we also incubated cadexomer beads overnight with bacterial suspensions on glass slides. Both histology with hematoxylin-eosin and Gram staining showed bacteria inside the cadexomer beads and surrounding them. In vivo studies also gave similar results. In summary, cadexomer beads, in addition to their property of absorbing fluid, can also act as a trap, at least temporary, for bacterial organisms. Simple washing of the beads quickly releases bacteria from the cadexomer beads. The mechanical removal of cadexomer beads before wound irrigation might limit exposure of the wound surface to trapped bacteria. These findings may have important clinical implications for treatment of infected wounds and for the technical development of better agents capable of trapping bacteria and other microorganisms.
Background: Conventional evaluation of wound healing ranges from visual inspection with clinical impression to length 3 width measurement to square counting to image analysis. These methods are useful but vary between observers and can be difficult to quantify accurately. There is a need for methods to determine the velocity of wound healing, which can objectively compare the healing rate of a specific wound over time, or rates of healing between groups of wounds for research studies. Methods and Results: We used a novel device (Visitrak) and principles of calculating wound dynamics to evaluate healing velocity in a variety of commonly encountered wounds and show that wound healing velocity is clinically useful for monitoring and managing patients. Using time-motion studies, we have determined that wound measurements using the Visitrak device are fast, accurate, and easy to learn compared to traditional methods of length 3 width and square counting. Conclusion: The concept of wound velocity measurement should be considered for managing patients in clinical practice as well as for quantifying speed of healing in research studies. Tracking wound dynamics using Visitrak is practical in the patient setting and facilitates clinical decision-making in selecting advanced modalities, including tissue engineered skin, growth factors, and other agents. Supported by a grant from the Angiogenesis Foundation and from Smith & Nephew
Nothing to disclose.
P3307 USING THE INTERNET TO ENTER DATA AND MANAGE A MULTINATIONAL CLINICAL TRIAL IN DEEP DERMAL AND THIRD-DEGREE BURNS Jules Mitchel, PhD, Target Health Inc., New York, NY, United States; Ronit Koren, PhD, Linda Gerstel, MS, Mediwound, Ltd., Yavne, Israel; Otto Mills, PhD, Robert Wood Johnson Medical School, New Brunswick, NJ, United States Global Internet-based clinical trials (G-IBCTs) can offer convenient, cost-effective solutions for streamlining aspects of the clinical research process. Areas affected by G-IBCTs include study startup, monitoring, implementation of protocol amendments, medical review of safety data, data management, query management, and project management. By decreasing time to database lock, companies can reduce overall development costs, accelerate the decision-making process, and decrease the time it takes to submit the marketing dossier. The study was a multicenter, multinational, clinical trial designed to evaluate a new debriding agent for the treatment of deep dermal and third-degree burns. Clinical research sites were in the United States, Europe, Eastern Europe, Israel, and India. Wound location was tracked electronically, so at follow-up visits, the appropriate wound locations automatically appeared. As new sites were added, the investigator and site personnel registered online and had rapid access to the case report forms (CRFs). As protocol amendments were approved by individual countries and individual institutional review boards, revised CRFs were immediately made available through a centrally controlled server. The key challenges for the study were (1) to create a user-friendly CRF, (2) for the clinical sites to enter the data in a timely manner, and (3) for the monitors to work closely with the sites to manage the implementation of this new paradigm in clinical research. For the majority of sites, we were able to monitor enrollment, safety, and key outcome variables in ‘‘real-time’’ and quickly intervene if problems arose. These major advantages allowed for an overall successful execution of the study. Nothing to disclose.
P212
J AM ACAD DERMATOL
P3309 MULTIMODAL TREATMENT OF PYODERMA GANGRENOSUM Vincent Li, MD, Angiogenesis Foundation, Cambridge, MA, United States Pyoderma gangrenosum is an inflammatory, ulcerative condition that can be difficult to treat. Currently, there is no specific, uniformly effective treatment for pyoderma gangrenosum. None of the currently used therapeutic modalities, including systemic immunosuppresion and topical agents, have been validated using controlled trials. We have devised a multimodal incremental therapeutic protocol in our approach of treating this condition and report our case series. Our protocol separates treatment into two phases: topical and systemic agents to suppress inflammation, and advanced modalities to accelerate wound healing. Nothing to disclose.
MARCH 2005
P3308
TRAPPING OF BACTERIA BY CADEXOMER BEADS IN VIVO AND IN VITRO Linda Zhou, MD, Janet Butmarc, Tatyana Yufit, MD, Boston UniversityeRoger Williams Medical Center, Providence, RI, United States; Vincent Falanga, MD, Department of Biochemistry, Boston University, Boston, MA, United States
MEASURING THE VELOCTY OF WOUND HEALING Vincent Li, MD, Angiogenesis Foundation, Cambridge, MA, United States
Slow-release antiseptics are increasingly being used in the treatment of exudative wounds with a high bacterial load. One such agent, cadexomer iodine, carries iodine (0.9% wt/wt) immobilized in beads of dextrin and epichlorhydrin and has been demonstrated to be highly effective in promoting healing of exudative wounds. We reported previously that cadexomer iodine lacks toxicity in vivo and in vitro, at least within a certain concentration range. Additionally, we also reported that, in vivo, bacteria can be found in the cadexomer beads. In this study, to test the hypothesis that cadexomer beads are capable of trapping bacteria, we used the vehicle cadexomer beads (without iodine) and exposed it to varying amounts of Escherichia coli in vitro. A number of experiments were performed, testing the optimal exposure time of bacteria to beads (up to 144 hours) and bacterial load in DMEM plus 10% FBS. In addition, we also incubated cadexomer beads overnight with bacterial suspensions on glass slides. Both histology with hematoxylin-eosin and Gram staining showed bacteria inside the cadexomer beads and surrounding them. In vivo studies also gave similar results. In summary, cadexomer beads, in addition to their property of absorbing fluid, can also act as a trap, at least temporary, for bacterial organisms. Simple washing of the beads quickly releases bacteria from the cadexomer beads. The mechanical removal of cadexomer beads before wound irrigation might limit exposure of the wound surface to trapped bacteria. These findings may have important clinical implications for treatment of infected wounds and for the technical development of better agents capable of trapping bacteria and other microorganisms.
Background: Conventional evaluation of wound healing ranges from visual inspection with clinical impression to length 3 width measurement to square counting to image analysis. These methods are useful but vary between observers and can be difficult to quantify accurately. There is a need for methods to determine the velocity of wound healing, which can objectively compare the healing rate of a specific wound over time, or rates of healing between groups of wounds for research studies. Methods and Results: We used a novel device (Visitrak) and principles of calculating wound dynamics to evaluate healing velocity in a variety of commonly encountered wounds and show that wound healing velocity is clinically useful for monitoring and managing patients. Using time-motion studies, we have determined that wound measurements using the Visitrak device are fast, accurate, and easy to learn compared to traditional methods of length 3 width and square counting. Conclusion: The concept of wound velocity measurement should be considered for managing patients in clinical practice as well as for quantifying speed of healing in research studies. Tracking wound dynamics using Visitrak is practical in the patient setting and facilitates clinical decision-making in selecting advanced modalities, including tissue engineered skin, growth factors, and other agents. Supported by a grant from the Angiogenesis Foundation and from Smith & Nephew
Nothing to disclose.
P3307 USING THE INTERNET TO ENTER DATA AND MANAGE A MULTINATIONAL CLINICAL TRIAL IN DEEP DERMAL AND THIRD-DEGREE BURNS Jules Mitchel, PhD, Target Health Inc., New York, NY, United States; Ronit Koren, PhD, Linda Gerstel, MS, Mediwound, Ltd., Yavne, Israel; Otto Mills, PhD, Robert Wood Johnson Medical School, New Brunswick, NJ, United States Global Internet-based clinical trials (G-IBCTs) can offer convenient, cost-effective solutions for streamlining aspects of the clinical research process. Areas affected by G-IBCTs include study startup, monitoring, implementation of protocol amendments, medical review of safety data, data management, query management, and project management. By decreasing time to database lock, companies can reduce overall development costs, accelerate the decision-making process, and decrease the time it takes to submit the marketing dossier. The study was a multicenter, multinational, clinical trial designed to evaluate a new debriding agent for the treatment of deep dermal and third-degree burns. Clinical research sites were in the United States, Europe, Eastern Europe, Israel, and India. Wound location was tracked electronically, so at follow-up visits, the appropriate wound locations automatically appeared. As new sites were added, the investigator and site personnel registered online and had rapid access to the case report forms (CRFs). As protocol amendments were approved by individual countries and individual institutional review boards, revised CRFs were immediately made available through a centrally controlled server. The key challenges for the study were (1) to create a user-friendly CRF, (2) for the clinical sites to enter the data in a timely manner, and (3) for the monitors to work closely with the sites to manage the implementation of this new paradigm in clinical research. For the majority of sites, we were able to monitor enrollment, safety, and key outcome variables in ‘‘real-time’’ and quickly intervene if problems arose. These major advantages allowed for an overall successful execution of the study. Nothing to disclose.
P212
J AM ACAD DERMATOL
P3309 MULTIMODAL TREATMENT OF PYODERMA GANGRENOSUM Vincent Li, MD, Angiogenesis Foundation, Cambridge, MA, United States Pyoderma gangrenosum is an inflammatory, ulcerative condition that can be difficult to treat. Currently, there is no specific, uniformly effective treatment for pyoderma gangrenosum. None of the currently used therapeutic modalities, including systemic immunosuppresion and topical agents, have been validated using controlled trials. We have devised a multimodal incremental therapeutic protocol in our approach of treating this condition and report our case series. Our protocol separates treatment into two phases: topical and systemic agents to suppress inflammation, and advanced modalities to accelerate wound healing. Nothing to disclose.
MARCH 2005