Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting

Kirsner, Robert S.; Sabolinski, Michael L.; Parsons, Nathan B.; Skornicki, Michelle; Marston, William A.

doi:10.1111/wrr.12332

Cited by 70 publications

(87 citation statements)

References 17 publications

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“…78,79 Studies comparing dHACMs to bioengineered skin substitutes have had various outcomes. 80,81 Another area of interest is the use of cryopreserved umbilical cord as adjunctive therapy. Small retrospective studies show that it may be helpful in wound healing, but RCTs are warranted to evaluate its true efficacy.…”

Section: Skin Grafts and Bioengineered Skinmentioning

confidence: 99%

Update on management of diabetic foot ulcers

Everett

Mathioudakis

2018

Annals of the New York Academy of Sciences

621

403

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Diabetic foot ulcers (DFUs) are a serious complication of diabetes that results in significant morbidity and mortality. Mortality rates associated with the development of a DFU are estimated to be 5% in the first 12 months, and 5-year morality rates have been estimated at 42%. The standard practices in DFU management include surgical debridement, dressings to facilitate a moist wound environment and exudate control, wound off-loading, vascular assessment, and infection and glycemic control. These practices are best coordinated by a multidisciplinary diabetic foot wound clinic. Even with this comprehensive approach, there is still room for improvement in DFU outcomes. Several adjuvant therapies have been studied to reduce DFU healing times and amputation rates. We reviewed the rationale and guidelines for current standard of care practices and reviewed the evidence for the efficacy of adjuvant agents. The adjuvant therapies reviewed include the following categories: nonsurgical debridement agents, dressings and topical agents, oxygen therapies, negative pressure wound therapy, acellular bioproducts, human growth factors, energy-based therapies, and systemic therapies. Many of these agents have been found to be beneficial in improving wound healing rates, although a large proportion of the data are small, randomized controlled trials with high risks of bias.

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Section: Skin Grafts and Bioengineered Skinmentioning

confidence: 99%

Update on management of diabetic foot ulcers

Everett

Mathioudakis

2018

Annals of the New York Academy of Sciences

621

403

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“…Living cellular construct (LCC) consists of a three‐dimensional bovine collagen matrix seeded with keratinocytes and dermal fibroblasts derived from human neonatal foreskin . LCC was the first allogenic cell‐based graft approved by the Food and Drug Administration and it has been shown to enhance wound healing and likelihood of complete wound closure in chronic wounds, diabetic foot ulcers, and venous leg ulcers .…”

Section: Fibroblast‐ and Keratinocyte‐based Combination Constructsmentioning

confidence: 99%

Living cell‐based regenerative medicine technologies for periodontal soft tissue augmentation

McGuire

Tavelli

Feinberg

et al. 2019

Journal of Periodontology

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The cultivation of human living cells into scaffolding matrices has progressively gained popularity in the field of periodontal wound healing and regeneration. Living cellular constructs based on fibroblasts, keratinocytes alone or in combination have been developed and used as alternatives to autogenous soft tissue grafts in keratinized tissue augmentation and in root coverage procedures. Their promising advantages include reduced patient morbidity, unlimited graft availability, and comparable esthetics. This manuscript reviews soft tissue augmentation and root coverage procedures using bioengineered living cellular therapy and highlights their expected clinical, esthetic, and patient‐related outcomes.

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“…By way of example, over the past decade, the USWR has consistently reported an average of 2.2 wounds per patient from its national database. This is significantly different from another national database, which reported an average of only 1 wound per patient . Since these datasets are of similar size and geographic distribution, were both obtained from hospital‐based outpatient wound centers, and represent wounds of similar etiologies, we must assume that the substantial difference in the number of wounds noted per patient is related somehow to registry methodology.…”

Section: Minimizing Selection Biasmentioning

confidence: 78%

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records

Fife

Eckert

2017

Wound Repair Regeneration

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The United States Food and Drug Administration will consider the expansion of coverage indications for some drugs and devices based on real‐world data. Real‐world data accrual in patient registries has historically been via manual data entry from the medical chart at a time distant from patient care, which is fraught with systematic error. The efficient automated transmission of data directly from electronic health records is replacing this labor‐intensive paradigm. However, real‐world data collection is unfamiliar. The potential sources of bias arising from the source of data and data accrual, documentation, and aggregation have not been well defined. Furthermore, the technological aspects of data acquisition and transmission are less transparent. We explore opportunities for harnessing direct‐from‐electronic health record registry reporting and propose the ABCs of Registries (Analysis of Bias Criteria of Registries), which are an evaluation framework for publications to minimize potential bias of real‐world data obtained directly from an electronic health record method. These standards are based on a point‐of‐care data documentation process using a common definitional framework and data dictionaries. By way of example, we describe a wound registry obtained directly from electronic health records. This qualified clinical data registry minimizes bias by ensuring complete and accurate point‐of‐care data capture, standardizes usual care linked to quality reporting, and prevents post‐hoc vetting of outcomes. The resulting data are of high quality and integrity and can be used for comparative effectiveness research in wound care. In this way, the effort needed to succeed with the Quality Payment Program is leveraged to obtain the real‐world data needed for comparative effectiveness research.

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Comparative effectiveness of a bioengineered living cellular construct vs. a dehydrated human amniotic membrane allograft for the treatment of diabetic foot ulcers in a real world setting

Cited by 70 publications

References 17 publications

Update on management of diabetic foot ulcers

Update on management of diabetic foot ulcers

Living cell‐based regenerative medicine technologies for periodontal soft tissue augmentation

Harnessing electronic healthcare data for wound care research: Standards for reporting observational registry data obtained directly from electronic health records

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