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

Abstract

Deep 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.

Statistical reporting in randomized controlled trials from the dermatology literature: a review of 44 dermatology journals

“…After manuscript review, two were excluded for being duplicates and 27 were excluded for not being RCTs. This left 181 articles in 27 journals to be included in the review . Of these, 137 studies had parallel‐armed control groups, 42 had placebo control groups, one was a cross‐over design and one used no treatment as the control group.…”

Made in Germany: A Quality Indicator Not Only in the Automobile Industry But Also When It Comes to Skin Replacement: How an Automobile Textile Research Institute Developed a New Skin Substitute

“…Superficial and partial-thickness burns covered with Suprathel ® , especially in more extensive burns, provide a comfortable and nearly painless treatment, with reduced stress for patients and reduced stress and workload for medical staff [89]. It can be combined with the tangential excision or enzymatic debridement in partial-thickness burns, and given the presence of a sufficient number of epidermal remnants, healing without complications can be expected in deeper partial-thickness burns, it can reduce the need for grafting [90][91][92][93] and can provide better cosmetic results than in mesh-grafted areas. This has been confirmed by validated scar scales (i.e., POSAS (Patient and Observer Scar Assessment Scale) and VSS (Vancouver Scar Scale) six months after the burn.…”

Effects of fiber density and plasma modification of nanofibrous membranes on the adhesion and growth of HaCaT keratinocytes

“…Artificial skin substitutes can be made from poly(HEMA), 4,5 polybuthylene terephthalate, 6 nylon, 7,8 hydroxybuthyrate, 9 polycaprolactone, 10 polylactic acid, 11 and polyglycolic acid, or their copolymers. 11,12 The most widely tested and applied natural biomaterials are chitosan, 13,14 collagen, 15 hyaluronic acid, 16,17 and chondroitin sulfate. 18 For our study, we used biodegradable nanofibrous membranes made from polylactic acid (polylactide, PLA).…”