A pre‐clinical functional assessment of an acellular scaffold intended for the treatment of hard‐to‐heal wounds

Shooter, Gary K.; Lonkhuyzen, Derek R. Van; Croll, Tristan I.; Cao, Yang; Xie, Yun; Broadbent, James A.; Stupar, Dario; Lynam, Emily; Upton, Zee

doi:10.1111/iwj.12073

Cited by 7 publications

(4 citation statements)

References 20 publications

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“…51 Use of these biomaterial-based systems for cell delivery, 39,161 gene delivery, 162,163 and also bioactive drug delivery 164,165 has been developed to restore or regenerate defective tissues. Additionally, application of scaffold as a skin equivalent alone, 166-168 in combination with cells, 169-172 GFs, 173,174 or both, 175-177 has been reported by many researchers for healing of wounds. According to one category, scaffolds are divided into 3 major groups: natural, synthetic, and composite scaffolds.…”

Section: Using Scaffolds For Wound Healingmentioning

confidence: 99%

Regeneration and Repair of Skin Wounds: Various Strategies for Treatment

Rezaie

Momeni-Moghaddam

Naderi‐Meshkin

2019

The International Journal of Lower Extremity Wounds

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Skin as a mechanical barrier between the inner and outer environment of our body protects us against infection and electrolyte loss. This organ consists of 3 layers: the epidermis, dermis, and hypodermis. Any disruption in the integrity of skin leads to the formation of wounds, which are divided into 2 main categories: acute wounds and chronic wounds. Generally, acute wounds heal relatively faster. In contrast to acute wounds, closure of chronic wounds is delayed by 3 months after the initial insult. Treatment of chronic wounds has been one of the most challenging issues in the field of regenerative medicine, promoting scientists to develop various therapeutic strategies for a fast, qualified, and most cost-effective treatment modality. Here, we reviewed more recent approaches, including the development of stem cell therapy, tissue-engineered skin substitutes, and skin equivalents, for the healing of complex wounds.

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Section: Using Scaffolds For Wound Healingmentioning

confidence: 99%

Regeneration and Repair of Skin Wounds: Various Strategies for Treatment

Rezaie

Momeni-Moghaddam

Naderi‐Meshkin

2019

The International Journal of Lower Extremity Wounds

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“…The ASM comes in a liquid format, which facilitates application and enables coverage of the irregular surface of a wound bed. It is adhesive by design and binds rapidly to the wound bed, forming a scaffold within minutes of application . Fibroblasts and keratinocytes attach to the temporary scaffold and subsequently migrate onto the wound bed and proliferate .…”

Section: Introductionmentioning

confidence: 99%

“…It is adhesive by design and binds rapidly to the wound bed, forming a scaffold within minutes of application . Fibroblasts and keratinocytes attach to the temporary scaffold and subsequently migrate onto the wound bed and proliferate . The ASM is intended to be used once per week as an adjunct to SC in the treatment of chronic wounds, primarily VLUs.…”

Section: Introductionmentioning

confidence: 99%

A single‐arm trial indirect comparison investigation: a proof‐of‐concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control

Shannon¹,

Nelson

2016

International Wound Journal

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Article:Shannon, R and Nelson, A orcid.org/0000-0001-6741-3078 (2017) A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control. International Wound Journal, 14 (4 ReuseUnless indicated otherwise, fulltext items are protected by copyright with all rights reserved. The copyright exception in section 29 of the Copyright, Designs and Patents Act 1988 allows the making of a single copy solely for the purpose of non-commercial research or private study within the limits of fair dealing. The publisher or other rights-holder may allow further reproduction and re-use of this version -refer to the White Rose Research Online record for this item. Where records identify the publisher as the copyright holder, users can verify any specific terms of use on the publisher's website. TakedownIf you consider content in White Rose Research Online to be in breach of UK law, please notify us by emailing eprints@whiterose.ac.uk including the URL of the record and the reason for the withdrawal request. Keywords: wound healing; non-healing leg ulcer; acellular synthetic matrix; predictive analytics; propensity score; venous ulcers; evidence network; VenUS I study, VenUS II study, VenUS III study, VenUS IV study 2 Abstract:PURPOSE: To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care and one matched from four large UK pragmatic, randomized controlled trials (venous leg ulcer evidence network). We introduce a new proof of concept strategy to a venous leg ulcer clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus standard care for success in future randomized, controlled clinical trials. SUBJECTS AND METHODS:Prospective data on chronic, venous leg ulcers from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound center in the UK (17 patients) and three wound centers in Australia (36 patients) were compared retrospectively to propensity score matched data from patients with comparable leg ulcer disease etiology, age, baseline ulcer area, ulcer duration, multilayer compression bandaging and majority of care completed in specialist wound centers (avg. 1 visit per week) with the outcome measures at comparable follow-up periods, from patients enrolled in four prospective, multicenter, pragmatic, randomized studies of venous ulcers in the United Kingdom (the comparison group; venous leg ulcer evidence network). RESULTS: CONCLUSIONS:Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to standard care in the treatment of non-healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison.

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“…The pre‐clinical work providing evidence that this synthetic matrix protein has the ability to function as an acellular scaffold for wound healing purposes has been reported in this Journal by Shooter et al . . The primary objective of the study reported in this article was the evaluation of the effectiveness and safety of this synthetic ECM protein.…”

Section: Introductionmentioning

confidence: 99%

Effectiveness of an acellular synthetic matrix in the treatment of hard‐to‐heal leg ulcers

Harding

Aldons

Edwards

et al. 2013

International Wound Journal

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Hard-to-heal leg ulcers are a major cause of morbidity in the elderly population. Despite improvements in wound care, some wounds will not heal and they present a significant challenge for patients and health care providers. A multi-centre cohort study was conducted to evaluate the effectiveness and safety of a synthetic, extracellular matrix protein as an adjunct to standard care in the treatment of hard-to-heal venous or mixed leg ulcers. Primary effectiveness criteria were (i) reduction in wound size evaluated by percentage change in wound area and (ii) healing assessed by number of patients healed by end of the 12 week study. Pain reduction was assessed as a secondary effectiveness criteria using VAS. A total of 45 patients completed the study and no difference was observed between cohorts for treatment frequency. Healing was achieved in 35·6% and wound size decreased in 93·3% of patients. Median wound area percentage reduction was 70·8%. Over 50% of patients reported pain on first visit and 87·0% of these reported no pain at the end of the study. Median time to first reporting of no pain was 14 days after treatment initiation. The authors consider the extracellular synthetic matrix protein an effective and safe adjunct to standard care in the treatment of hard-to-heal leg ulcers.

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A pre‐clinical functional assessment of an acellular scaffold intended for the treatment of hard‐to‐heal wounds

Cited by 7 publications

References 20 publications

Regeneration and Repair of Skin Wounds: Various Strategies for Treatment

Regeneration and Repair of Skin Wounds: Various Strategies for Treatment

A single‐arm trial indirect comparison investigation: a proof‐of‐concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control

Effectiveness of an acellular synthetic matrix in the treatment of hard‐to‐heal leg ulcers

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