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Prospective Study on the Treatment of Lower-Extremity Chronic Venous and Mixed Ulcers Using Tissue-Engineered Skin Substitute Made by the Self-assembly Approach

Boa, Olivier MD; Cloutier, Chanel Beaudoin MD; Genest, Hervé MD; Labbé, Raymond MD; Rodrigue, Bertrand MD; Soucy, Jacques MD; Roy, Michel MD; Arsenault, Frédéric MD; Ospina, Carlos E. MD; Dubé, Nathalie MSc; Rochon, Marie-Hélène MSc; Larouche, Danielle PhD; Moulin, Véronique J. PhD; Germain, Lucie PhD; Auger, François A. MD

doi: 10.1097/01.ASW.0000433102.48268.2a
FEATURES: ORIGINAL INVESTIGATIONS
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BACKGROUND: Despite present optimal standard treatment of lower-extremity ulceration, a high incidence of recurrence and treatment failure is observed. The objective of this project was to evaluate the effect of a self-assembled skin substitute (SASS) made by tissue engineering as a temporary cutaneous dressing in the treatment of hard-to-heal chronic ulcers.

PATIENTS AND METHODS: The prospective uncontrolled case study includes patients suffering from venous or mixed ulcers lasting more than 6 months and unresponsive to compression therapy, with an Ankle Brachial Index greater than 0.5. Compression therapy was combined with the weekly application of SASS, produced from the patient’s own skin cells, until healing. A weekly follow-up recorded wound size, skin aspect, pain, drainage, and percentage of wound healing. Photographs were also taken to assess ulcer evolution.

RESULTS: Fourteen ulcers present on 5 patients were treated. A mean of 6.7 SASS depositions by ulcer was required for healing. Two ulcers developed a minor wound infection, which was treated with oral antibiotics; another 2 ulcers recurred, and 1 healed with a second course of treatment, whereas 1 ulcer had a small recurrence treated with local wound care.

CONCLUSION: The authors’ study suggests that the SASS used as a biological dressing is a promising treatment for hard-to-heal chronic venous and mixed ulcers that are unresponsive to compression therapy.

The objective of this project was to evaluate the effect of a self-assembled skin substitute made by tissue-engineering as a temporary cutaneous dressing in the treatment of hard-to-heal chronic ulcers.

Olivier Boa, MD, is a Plastic Surgeon at Quebec CHU, Quebec City, Quebec, Canada. Chanel Beaudoin Cloutier, MD, is a Plastic Surgery Resident at Université Laval, Quebec City, Quebec, Canada. Hervé Genest, MD, is a Plastic Surgeon, and Raymond Labbé, MD, is a Plastic Surgeon; both at Quebec CHU, Quebec City, Quebec, Canada. Bertrand Rodrigue, MD, is a Dermatologic Surgeon (Retired) in Quebec City, Quebec, Canada. Jacques Soucy, MD, is a Dermatologist; Michel Roy, MD, is a Plastic Surgeon; and Frédéric Arsenault, MD, is a Plastic Surgeon; all at Quebec CHU, Quebec City, Quebec, Canada. Carlos E. Ospina, MD, is a Biological specialist at the Quebec Poison Center, Quebec City, Quebec, Canada. Nathalie Dubé, MSc, is a Nursing Clinical Advisor/Manager at the Vieille Capitale Health and Social Services Center (CSSS de la Vieille Capitale), Quebec City, Quebec, Canada. Marie-Hélène Rochon, MSc, is a Patent Agent at Norton Rose Fulbright Canada, Montreal, Quebec, Canada. Danielle Larouche, PhD, is Project Manager at Université Laval LOEX Center, Quebec City, Quebec, Canada. Véronique J. Moulin, PhD, is a Professor, and Lucie Germain, PhD, is a Professor; both at Université Laval, Quebec City, Quebec, Canada. François A. Auger, MD, is Director of Université Laval LOEX Center, Quebec City, Quebec, Canada.

Acknowledgments: The authors thank Jean-François Oligny, Marie-Josée Gauthier, Véronique Racine, Israël Martel, and Claudia Fugère for technical assistance, as well as Dr Dan Lacroix for critical reading of the manuscript. This work was supported by the foundation from Pompiers du Québec pour les Grands Brûlés (FPQGB), Canadian Institutes of Health Research (CIHR; MOP-14364) and Cell and Tissue Therapy Network (Thécell) from the Fonds de Recherche du Québec en Santé (FRQS). Dr Boa and Ms Rochon were FRQS scholarship recipients. Dr Germain held the Canadian Research Chair on Stem Cells and Tissue Engineering from the CIHR.

The authors have disclosed that they have no financial relationships related to this article. Submitted November 5, 2012; accepted in revised form March 8, 2013.

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