Concomitant heparin use promotes skin graft donor site healing by basic fibroblast growth factor: A pilot prospective randomized controlled study

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Contemporary Clinical Trials Communications Pub Date : 2024-09-24 DOI:10.1016/j.conctc.2024.101375
Keishi Kohyama , Hisakazu Kato , Hideshi Okada , Takuma Ishihara , Yuji Yasue , Ryo Kamidani , Kodai Suzuki , Takahito Miyake , Hiroshi Okuda , Hirofumi Shibata , Hiroyuki Tomita , Takenori Ogawa
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Abstract

Owing to its mitogenic and angiogenic characteristics, the use of basic fibroblast growth factor (bFGF) to promote wound healing has been investigated. However, its clinical efficacy has fallen short of expectations due to its instability. Heparin has been reported to stabilize bFGF. Therefore, we hypothesized that the combination of these agents would more effectively promote wound healing than bFGF alone; a single-center, two-arm parallel, single-blind, and a prospective randomized controlled pilot study was therefore performed involving 12 patients who underwent split-thickness skin graft harvesting. To ensure a feasible clinical treatment model, commercially available agents were used. The patients were randomly assigned to either the control group treated with bFGF (n = 6) or the intervention group treated with bFGF and heparin (n = 6) in a 1:1 ratio. The wound area and the wound area variation was assessed each week postoperatively, as was the number of days required for epithelialization. As a supplementary analysis, the least-squares means were calculated using a linear mixed-effects model. The results of this study indicate that the combination of bFGF and heparin may more effectively promote wound healing than bFGF alone, consistent with our hypothesis. A multicenter trial based on these data is ongoing.
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同时使用肝素可通过碱性成纤维细胞生长因子促进皮肤移植供体部位的愈合:前瞻性随机对照试验研究
由于碱性成纤维细胞生长因子(bFGF)具有促有丝分裂和血管生成的特性,人们一直在研究如何使用它来促进伤口愈合。然而,由于其不稳定性,其临床疗效并未达到预期。有报道称肝素能稳定碱性成纤维细胞生长因子。因此,我们假设,与单独使用 bFGF 相比,联合使用这两种药物能更有效地促进伤口愈合;因此,我们进行了一项单中心、双臂、平行、单盲、前瞻性随机对照试验研究,涉及 12 名接受分层厚皮移植术的患者。为确保临床治疗模式的可行性,研究使用了市售药物。患者按 1:1 的比例被随机分配到使用 bFGF 的对照组(n = 6)或使用 bFGF 和肝素的干预组(n = 6)。术后每周评估伤口面积和伤口面积变化,以及上皮化所需天数。作为补充分析,使用线性混合效应模型计算了最小二乘均值。本研究结果表明,与单独使用 bFGF 相比,联合使用 bFGF 和肝素能更有效地促进伤口愈合,这与我们的假设一致。基于这些数据的多中心试验正在进行中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Contemporary Clinical Trials Communications
Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology
CiteScore
2.70
自引率
6.70%
发文量
146
审稿时长
20 weeks
期刊介绍: Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.
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