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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引用次数: 0

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.

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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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