The Experts below are selected from a list of 309 Experts worldwide ranked by ideXlab platform
Katie Bakewell - One of the best experts on this subject based on the ideXlab platform.
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a real world experience with the bioactive human split thickness Skin Allograft for venous leg ulcers
Wound Repair and Regeneration, 2020Co-Authors: Robert S Kirsner, David J Margolis, Arti Masturzo, Katie BakewellAbstract:Data collected from standardized clinical practices can be valuable in evaluating the real-world therapeutic benefit of Skin substitutes in the treatment of venous leg ulcers (VLU). Utilizing such a dataset, this study aimed to validate the effectiveness of a bioactive human split-thickness Skin Allograft for the treatment of VLU in the real-world setting and to understand how certain variables impacted healing rates. From a pool of 1474 VLU treated with Allograft, 862 ulcers in 742 patients were selected from a large wound EMR database and analyzed. All patients received standard wound care prior to Allograft application. Impact of ulcer duration, number of applications, ulcer size, and time to application were analyzed. The VLU, on average, were of 189 days duration with a mean ulcer size of 19.3 cm2 . During treatment, 70.7% of wounds healed, with an average time to closure of 15 weeks (SD = 14.1 weeks). The percentage of VLU less than one-year duration that healed was significantly higher (72.3%) than the percentage of VLU with duration of greater than 1 years (51.5%) ( χ2 = 18.17; P < .001). Ulcers less than 10 cm2 in size were more likely to heal (73.9%) than those larger than 10 cm2 (67.9%) ( χ2 = 8.65, P = .03). VLU receiving Allograft within 90 days of initial presentation are 1.4 times more likely to heal vs those receiving their first BSA application after 90 days of standard of care (95% CI: [1.05, 1.86], P = .02). Allograft used in wound clinics healed a majority of refractory VLU, even in large ulcers of long duration, which are more difficult to heal. Smaller wound, size, and shorter wound duration were associated with greater likelihood of healing. VLUs treated earlier with Allograft had better healing outcomes. Clinicians may consider more aggressive and timely treatment with Allograft for refractory VLU.
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matched cohort study comparing bioactive human split thickness Skin Allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers a retrospective analysis across 470 institutions
Wound Repair and Regeneration, 2020Co-Authors: Adrian Barbul, Geoffrey C Gurtner, Hanna Gordon, Katie Bakewell, Marissa J CarterAbstract:This retrospective, matched-cohort study analyzed 1,556 patients with diabetic ulcers treated at 470 wound centers throughout the United States to determine the effectiveness of a cryopreserved bioactive split-thickness Skin Allograft plus standard of care when compared to standard of care alone. There were 778 patients treated with the graft in the treatment cohort, who were paired with 778 patients drawn from a pool of 126,864 candidates treated with standard of care alone (controls), by using propensity matching to create nearly identical cohorts. Both cohorts received standard wound care, including surgical debridement, moist wound care, and offloading. Logistic regression analysis of healing rates according to wound size, wound location, wound duration, volume reduction, exposed deep structures, and Wagner grade was performed. Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Diabetic ulcers were 59% more likely to close in the treatment cohort compared to the control cohort (p = 0.0045). The healing rate with the graft was better than standard of care across multiple subsets, but the most significant improvement was noted in the worst wounds that had a duration of 90-179 days prior to treatment (p = 0.0073), exposed deep structures (p = 0.036), and/or Wagner Grade 4 ulcers (p = 0.04). Furthermore, the decrease in recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without initially exposed deep structures (p < 0.05). The amputation rate in the treatment cohort was 41.7% less than that of the control cohort at 20 weeks (0.9% vs. 1.5%, respectively). This study demonstrated that diabetic ulcers treated with a cryopreserved bioactive split-thickness Skin Allograft were more likely to heal and remain closed compared to ulcers treated with standard of care alone.
Adam S. Landsman - One of the best experts on this subject based on the ideXlab platform.
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treatment of deep full thickness wounds containing exposed muscle tendon and or bone using a bioactive human Skin Allograft a large cohort case series
Wounds-a Compendium of Clinical Research and Practice, 2020Co-Authors: Michael S Flood, Blake Weeks, Kenneth O Anaeme, Heather Aguirre, Kimberlee B Hobizal, Sandi E Jiongco, Robert J Klein, Andrew Lemoi, Rafael Rafols, Adam S. LandsmanAbstract:BACKGROUND Deep wounds with exposed muscle, tendon, and/or bone structures are especially difficult to treat, often requiring a multifaceted approach. Bioactive human Skin Allograft (BSA) has been proven to be effective in the treatment of deep wounds, but the mechanism of action and clinical use in the real-world setting is not as well known. OBJECTIVE The aim of this case series is to study deep wounds treated with BSA to better understand how it is used in real-world patients and discuss its mechanism of action. MATERIALS AND METHODS A total of 51 deep wounds of various etiologies and locations were included from 10 sites across the United States. To be included, patients must have failed wound care without BSA for at least 30 days, with more than 50% reduction in size prior to BSA application. RESULTS The mean wound area was 50.37 cm2 and average wound duration was 3.67 months. The mean time to closure was 15.33 weeks, achieved with an average of 4.24 BSA applications. Many patients received adjunctive therapies either prior to or in combination with BSA. CONCLUSIONS This study demonstrates the effectiveness of BSA in the treatment of deep wounds of various etiologies. The authors provide clinical information on using BSA either alone or in conjunction with other advanced modalities and offer insight into the hypothesized mechanism of action in which these grafts become incorporated. Ultimately, this information can guide best practices in the treatment of full-thickness wounds to improve outcomes.
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Characterization of a Cryopreserved Split-Thickness Human Skin Allograft-TheraSkin.
Advances in skin & wound care, 2016Co-Authors: Adam S. Landsman, Eran Rosines, Amanda Houck, Angela C. Murchison, Alyce Linthurst Jones, Xiaofei Qin, Silvia S. Chen, Arnold R. LandsmanAbstract:ABSTRACTOBJECTIVE:The purpose of this study was to examine the characteristics of a cryopreserved split-thickness Skin Allograft produced from donated human Skin and compare it with fresh, unprocessed human split-thickness Skin.BACKGROUND:Cutaneous wound healing is a complex and organized process, w
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a prospective multicenter randomized controlled clinical trial comparing a bioengineered Skin substitute to a human Skin Allograft
Ostomy Wound Management, 2014Co-Authors: Lee Sanders, Jeremy J. Cook, Emily A. Cook, Adam S. Landsman, Arnold R. Landsman, Nelson Keller, Matthew HopsonAbstract:An estimated 25% of all people with diabetes may experience a foot ulcer in their lifetime, which may lead to serious complications including infection and amputation. A prospective, multicenter, randomized, controlled clinical trial was conducted to compare an in vitro-engineered, human fibroblast-derived dermal Skin (HFDS) substitute and a biologically active cryopreserved human Skin Allograft (HSA) to determine the relative number of diabetic foot ulcers (DFUs) healed (100% epithelialization without any drainage) and the number of grafts required by week 12. Secondary variables included the proportion of healed patients at weeks 16 and 20, time to healing during the study, and wound size progression. The 23 eligible participants (11 randomized to the HSA, 12 to the HFDS group) were recruited from two hospital-based outpatient wound care centers. Baseline patient (body mass index, age, gender, race, type and duration of diabetes, presence of neuropathy and/or peripheral arterial disease, tobacco use) and wound characteristics (size and duration) were recorded, and follow-up visits occurred every week for up to 20 weeks. Descriptive and multivariate regression analyses were used to compare wound outcomes. At baseline, no statistically significant differences between patients and wounds were observed. At week 12, seven (63.6%) patients in the HSA and four (33.3%) in the HFDS group were healed (P = 0.0498). At the end of the 20-week evaluation period, 90.91% of HSA versus 66.67% of HFDS were healed (P = 0.4282). Among the subset of wounds that healed during the first 12 weeks of treatment, an average of 4.36 (range 2-7) HSA grafts were applied versus 8.92 (range 6-12) in the HFDS subset (P <0.0001, SE 0.77584). Time to healing in the HSA group was significantly shorter (8.9 weeks) than in the HFDS group (12.5 weeks) (log-rank test, P = 0.0323). The results of this study are similar to previous outcomes reported using these treatment modalities and suggest that, after 12 weeks of care, DFUs managed with HSA are approximately twice as likely to heal as DFUs managed with HFDS with approximately half the number of grafts required. Research confirming these results with a larger sample size and inpatients with different types of wounds is warranted.
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a prospective comparison of diabetic foot ulcers treated with either a cryopreserved Skin Allograft or a bioengineered Skin substitute
Wounds-a Compendium of Clinical Research and Practice, 2011Co-Authors: Lawrence A Didomenico, Arnold R. Landsman, Kenneth J Emch, Adam S. LandsmanAbstract:UNLABELLED Background. It was hypothesized that the rate of wound closure and the number of grafts required will be the same when treating diabetic foot ulcers with TheraSkin®, a cryopreserved split-thickness Skin Allograft (SSA), as compared to Apligraft®, a bioengineered Skin substitute (BSS). METHODS A prospective study using sequentially enrolled patients seen in a large podiatric practice encompassing multiple locations was conducted. Patients were sequentially enrolled and treated with either BSS or SSA. All other factors of treatment were standardized across the patient population. Data analysis included an analysis of co-factors in each group in order to determine if anything else may have influenced the outcomes. RESULTS Data from 17 wounds (16 patients) treated with BSS and 12 wounds treated with SSA were analyzed. The average wound sizes were comparable, as was the average number of applications utilized. These data revealed that 41.3% of the wounds treated with BSS closed within 12 weeks, as compared to 66.7% of the wounds treated with SSA. At 20 weeks, 47.1% of the wounds in the BSS group closed, while 66.7% of the SSA wounds closed. There were a comparable number of adverse events in each group, with none that were a direct result of the biologic material being used. CONCLUSION SSA resulted in a higher percentage of wounds closing after 12 and 20 weeks, as compared to wounds treated with BSS. There were no adverse events noted that were directly related to either graft material.
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A Retrospective Clinical Study of 188 Consecutive Patients to Examine the Effectiveness of a Biologically Active Cryopreserved Human Skin Allograft (TheraSkin ®) on the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers
Foot and Ankle Specialist, 2010Co-Authors: Jeremy J. Cook, Emily A. Cook, Philip Garrett, Joonhyun Yoon, Alfred Kirkwood, Adam S. Landsman, Eric DesmanAbstract:A biologically active human Skin Allograft, currently distributed under the brand name TheraSkin®, was examined for safety and efficacy in the treatment of venous leg ulcers (VLUs) and diabetic foot ulcers (DFUs). The objective was to determine if TheraSkin could serve as a safe and effective alternative to bioengineered Skin substitutes such as Apligraf® and Dermagraft®. The authors conducted a retrospective study of 214 consecutive patients seen at the Inova Wound Center (Mt Vernon, Virginia), with either a DFU or a VLU. After excluding patients who did not meet the study criteria, the final eligible cohort consisted of 188 subjects, with 134 VLUs and 54 DFUs. Multivariate logistic regression was used to evaluate the relationship between baseline wound size and the proportion of healed wounds after 12 and 20 weeks from initial Allograft application. The authors found that by the 12th week, DFUs closed 60.38% of the time and VLUs closed 60.77% of the time. After 20 weeks, the number of closed DFUs increa...
Adrian Barbul - One of the best experts on this subject based on the ideXlab platform.
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matched cohort study comparing bioactive human split thickness Skin Allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers a retrospective analysis across 470 institutions
Wound Repair and Regeneration, 2020Co-Authors: Adrian Barbul, Geoffrey C Gurtner, Hanna Gordon, Katie Bakewell, Marissa J CarterAbstract:This retrospective, matched-cohort study analyzed 1,556 patients with diabetic ulcers treated at 470 wound centers throughout the United States to determine the effectiveness of a cryopreserved bioactive split-thickness Skin Allograft plus standard of care when compared to standard of care alone. There were 778 patients treated with the graft in the treatment cohort, who were paired with 778 patients drawn from a pool of 126,864 candidates treated with standard of care alone (controls), by using propensity matching to create nearly identical cohorts. Both cohorts received standard wound care, including surgical debridement, moist wound care, and offloading. Logistic regression analysis of healing rates according to wound size, wound location, wound duration, volume reduction, exposed deep structures, and Wagner grade was performed. Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Diabetic ulcers were 59% more likely to close in the treatment cohort compared to the control cohort (p = 0.0045). The healing rate with the graft was better than standard of care across multiple subsets, but the most significant improvement was noted in the worst wounds that had a duration of 90-179 days prior to treatment (p = 0.0073), exposed deep structures (p = 0.036), and/or Wagner Grade 4 ulcers (p = 0.04). Furthermore, the decrease in recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without initially exposed deep structures (p < 0.05). The amputation rate in the treatment cohort was 41.7% less than that of the control cohort at 20 weeks (0.9% vs. 1.5%, respectively). This study demonstrated that diabetic ulcers treated with a cryopreserved bioactive split-thickness Skin Allograft were more likely to heal and remain closed compared to ulcers treated with standard of care alone.
Philip M. Murphy - One of the best experts on this subject based on the ideXlab platform.
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The Macrophage-depleting Agent Clodronate Promotes Durable Hematopoietic Chimerism and Donor-specific Skin Allograft Tolerance in Mice
Scientific Reports, 2016Co-Authors: Zhanzhuo Li, Xin Xu, Xingmin Feng, Philip M. MurphyAbstract:Hematopoietic chimerism is known to promote donor-specific organ Allograft tolerance; however, clinical translation has been impeded by the requirement for toxic immunosuppression and large doses of donor bone marrow (BM) cells. Here, we investigated in mice whether durable chimerism might be enhanced by pre-treatment of the recipient with liposomal clodronate, a macrophage depleting agent, with the goal of vacating BM niches for preferential reoccupation by donor hematopoietic stem cells (HSC). We found that liposomal clodronate pretreatment of C57BL/6 mice permitted establishment of durable hematopoietic chimerism when the mice were given a low dose of donor BM cells and transient immunosuppression. Moreover, clodronate pre-treatment increased durable donor-specific BALB/c Skin Allograft tolerance. These results provide proof-of-principle that clodronate is effective at sparing the number of donor BM cells required to achieve durable hematopoietic chimerism and donor-specific Skin Allograft tolerance and justify further development of a tolerance protocol based on this principle.
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pre treatment of allogeneic bone marrow recipients with the cxcr4 antagonist amd3100 transiently enhances hematopoietic chimerism without promoting donor specific Skin Allograft tolerance
Transplant Immunology, 2015Co-Authors: Ido D Weiss, Orit Jacobson, Philip M. MurphyAbstract:Abstract Hematopoietic chimerism established by allogeneic bone marrow transplantation is known to promote donor-specific organ Allograft tolerance; however, clinical application is limited by the need for toxic host conditioning and “megadoses” of donor bone marrow cells. A potential solution to this problem has been suggested by the observation that recipient bone marrow mobilization by the CXCR4 antagonist AMD3100 promotes chimerism in congenic bone marrow transplantation experiments in mice. Here we report that a single subcutaneous dose of 10 mg/kg AMD3100 in recipient C57BL/6 mice was able to enhance hematopoietic chimerism when complete MHC-mismatched BALB/c donor bone marrow cells were transplanted 1 h after drug dosing. However, levels of chimerism measured 30 days post-transplantation were not sustained when mice were reexamined on day 90 post-transplantation. Moreover, transient chimerism induced by this protocol did not support robust donor-specific Skin Allograft tolerance. Using the same transient immunosuppression protocol, we confirmed that “megadoses” of donor bone marrow cells could induce durable chimerism associated with donor-specific Skin Allograft tolerance without AMD3100 pre-treatment. We conclude that in this protocol AMD3100 pretreatment may empty bone marrow niches that become reoccupied by allogeneic donor hematopoietic progenitor cells but not by true long-lived donor hematopoietic stem cells, resulting in short-lived chimerism and failure to support durable donor-specific Allograft tolerance.
Marissa J Carter - One of the best experts on this subject based on the ideXlab platform.
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matched cohort study comparing bioactive human split thickness Skin Allograft plus standard of care to standard of care alone in the treatment of diabetic ulcers a retrospective analysis across 470 institutions
Wound Repair and Regeneration, 2020Co-Authors: Adrian Barbul, Geoffrey C Gurtner, Hanna Gordon, Katie Bakewell, Marissa J CarterAbstract:This retrospective, matched-cohort study analyzed 1,556 patients with diabetic ulcers treated at 470 wound centers throughout the United States to determine the effectiveness of a cryopreserved bioactive split-thickness Skin Allograft plus standard of care when compared to standard of care alone. There were 778 patients treated with the graft in the treatment cohort, who were paired with 778 patients drawn from a pool of 126,864 candidates treated with standard of care alone (controls), by using propensity matching to create nearly identical cohorts. Both cohorts received standard wound care, including surgical debridement, moist wound care, and offloading. Logistic regression analysis of healing rates according to wound size, wound location, wound duration, volume reduction, exposed deep structures, and Wagner grade was performed. Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. Diabetic ulcers were 59% more likely to close in the treatment cohort compared to the control cohort (p = 0.0045). The healing rate with the graft was better than standard of care across multiple subsets, but the most significant improvement was noted in the worst wounds that had a duration of 90-179 days prior to treatment (p = 0.0073), exposed deep structures (p = 0.036), and/or Wagner Grade 4 ulcers (p = 0.04). Furthermore, the decrease in recidivism was statistically significant at 3 months, 6 months, and 1 year, with and without initially exposed deep structures (p < 0.05). The amputation rate in the treatment cohort was 41.7% less than that of the control cohort at 20 weeks (0.9% vs. 1.5%, respectively). This study demonstrated that diabetic ulcers treated with a cryopreserved bioactive split-thickness Skin Allograft were more likely to heal and remain closed compared to ulcers treated with standard of care alone.