Search Results - "Smiell, Janice"

A phase 3b, open-label, single-arm, multicenter, expanded-access study of the safety and clinical outcomes of StrataGraft® treatment in adults with deep partial-thickness thermal burns by Holmes IV, James H., Gibson, Angela L.F., Short, Tracee, Joe, Victor C., Litt, Jeffrey, Carson, Joshua, Carter, Jeffrey E., Wibbenmeyer, Lucy, Hahn, Helen, Smiell, Janice M., Rutan, Randi, Wu, Richard, Shupp, Jeffrey W.

“…A phase 3b, open-label, multicenter, expanded-access study (NCT04123548) evaluated safety and clinical outcomes of StrataGraft treatment in adults with deep…”
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A phase 3, open-label, controlled, randomized, multicenter trial evaluating the efficacy and safety of StrataGraft® construct in patients with deep partial-thickness thermal burns by Gibson, Angela L.F., Holmes, James H., Shupp, Jeffrey W., Smith, David, Joe, Victor, Carson, Joshua, Litt, Jeffrey, Kahn, Steven, Short, Tracee, Cancio, Leopoldo, Rizzo, Julie, Carter, Jeffrey E., Foster, Kevin, Lokuta, Mary A., Comer, Allen R., Smiell, Janice M., Allen-Hoffmann, B. Lynn

“…•StrataGraft treatment eliminated donor tissue harvest in all but 3 of 71 patients.•At Month 3, 92% of StrataGraft treatment sites achieved durable wound…”
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Pooled safety analysis of STRATA2011 and STRATA2016 clinical trials evaluating the use of StrataGraft® in patients with deep partial-thickness thermal burns by Holmes IV, James H., Cancio, Leopoldo C., Carter, Jeffrey E., Faucher, Lee D., Foster, Kevin, Hahn, Helen D., King, Booker T., Rutan, Randi, Smiell, Janice M., Wu, Richard, Gibson, Angela L.F.

“…This analysis includes pooled safety data from 2 clinical trials (NCT01437852; NCT03005106) that evaluated the safety and efficacy of StrataGraft in patients…”
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Real-world Experience With a Decellularized Dehydrated Human Amniotic Membrane Allograft by Smiell, Janice M, Treadwell, Terry, Hahn, Helen D, Hermans, Michel H

“…While randomized controlled trials (RCTs) are designed to evaluate efficacy and/or safety under controlled conditions, use of strict inclusion/ exclusion…”
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Modulation of Cell Attachment, Proliferation, and Angiogenesis by Decellularized, Dehydrated Human Amniotic Membrane in In Vitro Models by Guo, Xuan, Kaplunovsky, Aleksandr, Zaka, Raihana, Wang, Chuan, Rana, Hemlata, Turner, Jeffrey, Ye, Qian, Djuretic, Ivana, Gleason, Joseph, Jankovic, Vladimir, Smiell, Janice M, Bhatia, Mohit, Hofgartner, Wolfgang, Hariri, Robert

“…Decellularized, dehydrated human amniotic membrane (DDHAM) is an extracellular matrix devoid of cells, cell debris, and growth factors. This study examines the…”
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Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase III randomized placebo-controlled double-blind study by Wieman, T J, Smiell, J M, Su, Y

“…Efficacy and safety of a topical gel formulation of recombinant human platelet-derived growth factor-BB (becaplermin) in patients with chronic neuropathic…”
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Efficacy and safety of becaplermin (recombinant human platelet-derived growth factor-BB) in patients with nonhealing, lower extremity diabetic ulcers: a combined analysis of four randomized studies by Smiell, Janice M, Wieman, T. Jeffery, Steed, David L, Perry, Barbara H, Sampson, Allan R, Schwab, Barry H

“…The results of a combined analysis and separate analyses of four multicenter, randomized, parallel group studies that evaluated the effects of once‐daily…”
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Recombinant human platelet-derived growth factor-BB (becaplermin) for healing chronic lower extremity diabetic ulcers: an open-label clinical evaluation of efficacy by Embil, John M, Papp, Kim, Sibbald, Gary, Tousignant, Jacqueline, Smiell, Janice M, Wong, Betty, Lau, Cathy Y

“…Topically applied recombinant human platelet‐derived growth factor‐BB (becaplermin) is a new pharmacologically active therapy for chronic, neuropathic, lower…”
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Navigating the Regulatory Pathways and Requirements for Tissue-Engineered Products in the Treatment of Burns in the United States by Belsky, Kimberly, Smiell, Janice

“…Abstract In the burn treatment landscape, a variety of skin substitutes, human tissue-sourced products, and other products are being developed based on tissue…”
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Equivocal role of micelles in Eprex adverse events by Schellekens, Huub, Crommelin, Daan J A

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Becaplermin gel in the treatment of pressure ulcers: a phase II randomized, double-blind, placebo-controlled study by Rees, Riley S, Robson, Martin C, Smiell, Janice M, Perry, Barbara H

“…Pressure ulcers are associated with significant rates of morbidity and mortality, particularly in the geriatric and spinal cord–injured populations. Newer…”
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Healthcare resource utilization, treatment patterns, and cost of care among patients with thermal burns and inpatient autografting in two large privately insured populations in the United States by Yu, Tzy-Chyi, Zhang, Xian, Smiell, Janice, Zhou, Huanxue, Tan, Ruixin, Böing, Elaine, Tan, Hiangkiat

“…•Major economic burdens exist for thermal burn injury with inpatient autografting.•This cost burden is mainly driven by initial hospitalization with…”
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Clinical safety of becaplermin (rhPDGF-BB) gel by Smiell, Janice M.

“…This overview of the safety of becaplermin gel is based on six well-controlled clinical studies that included patients with lower extremity diabetic…”
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Determining clinically meaningful thresholds for innovative burn care products to reduce autograft: A US burn surgeon Delphi panel by Gibson, Angela L.F., Smiell, Janice, Yu, Tzy-Chyi, Böing, Elaine A., McClure, Erika Brockfeld, Merikle, Elizabeth, Holmes, James H.

“…•Delphi Panel identified clinically meaningful reduction thresholds in donor skin for autograft.•Reduction in amount of harvested donor skin would facilitate…”
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730 Establishing Thresholds for Clinically Significant Donor Skin Reduction – Initial Findings from a Physician Delphi Consensus Panel by Gibson, Angela, Smiell, Janice, McClure, Erika I Brockfeld, Patel, Reema, Skorija, Kristi, Holmes, James H, Yu, Tzy-Chyi, Boing, Elaine A, Merikle, Elizabeth

“…Abstract Introduction Definitive closure with autograft, as a current standard of care, is a critical outcome in severe burn treatment. Harvest of donor skin…”
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Response to Letter to the Editor “Defining a meaningful reduction of donor sites—Not as easy as it seems” by Gibson, Angela L.F., Smiell, Janice, Yu, Tzy-Chyi, Böing, Elaine A., McClure, Erika Brockfeld, Merikle, Elizabeth, Holmes, James H.

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A meta-analytic approach to an integrated summary of efficacy: a case study of becaplermin gel by Perry, Barbara H., Sampson, Allan R., Schwab, Barry H., Karim, M.Rezaul, Smiell, Janice M.

“…This paper presents a case study involving a meta-analytic approach for an integrated summary of efficacy based upon four phase II and III clinical trials that…”
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Letter 1: Equivocal role of micelles in Eprex adverse events by Smiell, Janice M

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Equivocal role of micelles in Eprex adverse events by Smiell, Janice M

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Skin perfusion pressure measurement is valuable in the diagnosis of critical limb ischemia by Castronuovo, John J., Adera, Habtu M., Smiell, Janice M., Price, Ray M.

“…Purpose: Critical limb ischemia (CLI) is equated with a need for limb salvage. Arterial reconstruction and major amputation are the therapies ultimately…”
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