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To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial

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Abstract

The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (Grades 3 Wagner) were included in this randomized clinical trial. The study was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with Integra Flowable Wound Matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; p = 0.001). Amputation and rehospitalization rates were higher in the control group compared to the first group, therefore, the difference was statistically significant (p = 0.0019; p = 0.028, respectively). The Integra Flowable Wound Matrix, was significantly superior, compared to the wet dressing, by promoting the complete healing of diabetic foot ulcers. Ease of use, absence of adverse effects, and a facilitated wound healing process are among the properties of the matrix. These characteristics make it appropriate in the management of diabetic foot ulcers. Additional research will shed more light on the promising advantages of this material in healing diabetic foot ulcers.

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Abbreviations

DFUs:

Diabetic foot ulcers

TNF:

Tumor necrosis factor

IL-1b:

Interleukin 1 beta

VEGF:

Vascular endothelial growth factor

MMPs:

Matrix metalloproteinases

PPAR:

Peroxisome proliferator-activated receptors

IFWM:

Integra TM Flowable Wound Matrix

ABI:

Ankle-brachial index

CI:

Confidence interval

MDNS:

Michigan Diabetic Neuropathy Screening Score

MIC:

Minimal inhibitory concentration

PP:

Per-Protocol

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Acknowledgements

The authors would like to acknowledge the Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences for providing patients and necessary staff for this study.

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Authors and Affiliations

  1. Department of Medical, Surgical, Neurologic, Metabolic and Aging Sciences, University of Campania “Luigi Vanvitelli”, Piazza Miraglia, 2, 80138, Naples, Italy

    F. Campitiello, M. Mancone, A. Della Corte, R. Guerniero & S. Canonico

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  1. F. Campitiello
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  2. M. Mancone
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  3. A. Della Corte
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  4. R. Guerniero
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  5. S. Canonico
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Correspondence to M. Mancone.

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The authors declare the absence of any potential conflict of financial interest (or none) for all authors.

Research involving human participants and/or animals

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Informed consent was obtained from all individual participants included in the study.

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Campitiello, F., Mancone, M., Della Corte, A. et al. To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial. Updates Surg 69, 523–529 (2017). https://doi.org/10.1007/s13304-017-0461-9

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  • DOI: https://doi.org/10.1007/s13304-017-0461-9

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