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Randomized Controlled Trial
The use of a polylactide-based copolymer as a temporary skin substitute in deep dermal burns: 1-year follow-up results of a prospective clinical noninferiority trial.
- Harald F Selig, Maike Keck, David B Lumenta, Martina Mittlböck, and Lars P Kamolz.
- Vienna Burn Center, Division of Plastic and Reconstructive Surgery, Department of Surgery, Medical University of Vienna, Vienna, Austria. selighf@gmail.com
- Wound Repair Regen. 2013 May 1;21(3):402-9.
AbstractDeep dermal burns can be covered with different kind of materials and techniques; one of them is a polylactide-based temporary skin substitute. The aim of this study was to intraindividually compare its 1-year outcome with the results obtained by use of autologous skin grafts in patients suffering from deep dermal burns. A prospective noninferiority trial was designed in order to assess skin quality and scar formation by use of subjective (Vancouver Scar Scale; Patient and Observer Scar Assessment Scale) and objective (noninvasive cutometry) burn scar assessment tools. All items of the Patient and Observer Scar Assessment Scale, except vascularity, were found to be noninferior in the areas covered with the temporary skin substitute vs. autologous skin. Results of objective scar evaluation showed comparable viscoelastic parameters without reaching noninferiority. Overall, the outcome of deep dermal burns covered with a polylactide-based temporary skin substitute revealed satisfactory results in terms of scar formation and skin quality as compared with autologous skin. This paper supports its use in deep dermal burns, where autologous skin donor sites require either to be reserved for coverage of full-thickness skin defects in severe burns or to be saved for reduction of additional morbidity in selected patient collectives.© 2013 by the Wound Healing Society.
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