An Open-Label, Interventional, Prospective, Real-World Evidence Study to Evaluate a Multimodal Wound Matrix in Patients with Refractory Wounds.

IF 5.8 3区 医学 Q1 DERMATOLOGY
Yadwinder Dhillon, Gerit Mulder, Keyur Patel, Luis Moya, Gerard Boghossian, David Swain, Robert McLafferty, Kelly Perez, Jessica Nguyen, Natalie Wilkinson, Jessica Arragon, Lillia Contreras, Donna Geiger, Ryan Cummings, Brenda LaVigne, Desmond Bell, Suzanne Bakewell
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Abstract

Objective: The objective of this open-label, interventional, prospective clinical study was to evaluate the effectiveness of a multimodal wound matrix (MWM) in moving chronic, nonhealing wounds that had failed prior therapies onto a healing trajectory. The overall response rate was the proportion of subjects who had greater than 40% reduction in size after 4 weeks of treatment. Secondary objectives included the percentage area reduction (PAR) after 4 and 12 weeks, incidence of ulcer closing, and changes in quality of life. Approach: An open-label, interventional, prospective cohort, real-world evidence study was conducted following the STROBE criteria. Criteria included chronic nonhealing wounds of multiple etiologies in subjects with extensive comorbidities. Results were compared with data from the U.S. Wound Registry. Results: A total of 111 subjects entered the screening phase and 64 were treated. Fifty-three wounds were eligible for the dataset that included 18 diabetic foot ulcers, 19 venous leg ulcers, 2 pressure injuries, 1 surgical, 1 lower extremity wound, and 12 unclassified etiologies. The objective response rate was 42%. The 4-week PAR was 34%. The 12-week PAR was 66%. Eighteen wounds closed by week 12. Innovation: MWM is a formulation technology developed to address the major obstacles that prevent healing. Results were evaluated in a patient population with extensive comorbidities that had failed prior treatments and would be generally excluded from controlled trials. Conclusion: The results from this study support the contention that MWM achieves substantial clinical improvement in a complex patient population not enrolled in clinical trials and demonstrates an advancement in wound management.

一项开放标签、介入性、前瞻性、真实世界证据研究评估难治性伤口患者的多模态伤口基质。
目的:这项开放标签、介入性、前瞻性临床研究的目的是评估多模态伤口基质(MWM)在将先前治疗失败的慢性、不愈合伤口转移到愈合轨道上的有效性。总体缓解率是指在治疗4周后体型缩小超过40%的受试者比例。次要目标包括4周和12周后的面积缩小百分比(PAR)、溃疡愈合的发生率和生活质量的变化。方法:遵循STROBE标准进行一项开放标签、干预性、前瞻性队列、真实世界证据研究。标准包括多种病因的慢性不愈合伤口和广泛的合并症。结果与美国伤口登记处的数据进行了比较。结果:共有111名受试者进入筛选阶段,64名受试者接受治疗。53处伤口纳入数据集,包括18处糖尿病足溃疡、19处腿部静脉溃疡、2处压伤、1处外科伤口、1处下肢伤口和12处未分类的病因。客观有效率为42%。4周PAR为34%。12周PAR为66%。到第12周,18个伤口愈合。创新:MWM是一种配方技术,旨在解决阻碍愈合的主要障碍。结果在具有广泛合并症的患者人群中进行评估,这些患者先前治疗失败,通常被排除在对照试验之外。结论:本研究的结果支持MWM在未参加临床试验的复杂患者群体中取得实质性临床改善的观点,并证明了伤口管理的进步。
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来源期刊
Advances in wound care
Advances in wound care Medicine-Emergency Medicine
CiteScore
12.10
自引率
4.10%
发文量
62
期刊介绍: Advances in Wound Care rapidly shares research from bench to bedside, with wound care applications for burns, major trauma, blast injuries, surgery, and diabetic ulcers. The Journal provides a critical, peer-reviewed forum for the field of tissue injury and repair, with an emphasis on acute and chronic wounds. Advances in Wound Care explores novel research approaches and practices to deliver the latest scientific discoveries and developments. Advances in Wound Care coverage includes: Skin bioengineering, Skin and tissue regeneration, Acute, chronic, and complex wounds, Dressings, Anti-scar strategies, Inflammation, Burns and healing, Biofilm, Oxygen and angiogenesis, Critical limb ischemia, Military wound care, New devices and technologies.
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