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

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.

[1]  X. Thomas,et al.  First Results of a Prospective Study on Erythropoietin Biosimilar (Epoetin zeta) Use in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation for Hematological Malignancies , 2015 .

[2]  E. Caterson,et al.  Tissue engineering of skin. , 2013, Journal of the American College of Surgeons.

[3]  M. Shah,et al.  Use of Suprathel® for partial thickness burns in children. , 2013, Burns : journal of the International Society for Burn Injuries.

[4]  M. Mittlböck,et al.  The use of Suprathel(®) in deep dermal burns: first results of a prospective study. , 2012, Burns : journal of the International Society for Burn Injuries.

[5]  O. Lotter,et al.  A clinical evaluation of Biobrane(®) and Suprathel(®) in acute burns and reconstructive surgery. , 2011, Burns : journal of the International Society for Burn Injuries.

[6]  Michel Vert,et al.  Degradable Polymers in Medicine: Updating Strategies and Terminology , 2011, The International journal of artificial organs.

[7]  I. Kaartinen,et al.  Suprathel® causes less bleeding and scarring than Mepilex® Transfer in the treatment of donor sites of split-thickness skin grafts , 2011, Journal of plastic surgery and hand surgery.

[8]  H. Hoeksema,et al.  Burn scar assessment: A systematic review of objective scar assessment tools. , 2010, Burns : journal of the International Society for Burn Injuries.

[9]  M. Landthaler,et al.  Management of Split-Thickness Donor Sites With Synthetic Wound Dressings: Results of a Comparative Clinical Study , 2010, Annals of plastic surgery.

[10]  Susanne Hellmich,et al.  Suprathel–Acetic Acid Matrix Versus Acticoat and Aquacel as an Antiseptic Dressing: An In Vitro Study , 2010, Annals of plastic surgery.

[11]  Susanne Hellmich,et al.  Antiseptic therapy with a polylacticacid–acetic acid matrix in burns , 2010, Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society.

[12]  P. Vogt,et al.  [Skin tissue engineering--from split skin to engineered skin grafts?]. , 2010, Handchirurgie, Mikrochirurgie, plastische Chirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Handchirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Mikrochirurgie der Peripheren Nerven und Gefasse : Organ der V....

[13]  L. Kamolz,et al.  The treatment of deep dermal hand burns: How do we achieve better results? Should we use allogeneic keratinocytes or skin grafts? , 2010, Burns : journal of the International Society for Burn Injuries.

[14]  J. Leon-Villapalos,et al.  The use of human deceased donor skin allograft in burn care , 2010, Cell and Tissue Banking.

[15]  Robert Sheridan,et al.  Closure of the excised burn wound: autografts, semipermanent skin substitutes, and permanent skin substitutes. , 2009, Clinics in plastic surgery.

[16]  H. Ryssel,et al.  The antimicrobial effect of acetic acid--an alternative to common local antiseptics? , 2009, Burns : journal of the International Society for Burn Injuries.

[17]  L. Kamolz,et al.  Adult Burn Patients With More Than 60% TBSA Involved–Meek and Other Techniques to Overcome Restricted Skin Harvest Availability–The Viennese Concept , 2009, Journal of burn care & research : official publication of the American Burn Association.

[18]  L. Prantl,et al.  Suprathel, a New Skin Substitute, in the Management of Partial-Thickness Burn Wounds: Results of a Clinical Study , 2008, Annals of plastic surgery.

[19]  L. Kamolz,et al.  Tissue engineering for cutaneous wounds: an overview of current standards and possibilities , 2008, European Surgery.

[20]  L. Prantl,et al.  Suprathel, a new skin substitute, in the management of donor sites of split-thickness skin grafts: results of a clinical study. , 2007, Burns : journal of the International Society for Burn Injuries.

[21]  C. Uhlig,et al.  [New strategies for the treatment of thermally injured hands with regard to the epithelial substitute Suprathel]. , 2007, Handchirurgie, Mikrochirurgie, plastische Chirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Handchirurgie : Organ der Deutschsprachigen Arbeitsgemeinschaft fur Mikrochirurgie der Peripheren Nerven und Gefasse : Organ der V....

[22]  H. Planck,et al.  Suprathel-an innovative, resorbable skin substitute for the treatment of burn victims. , 2007, Burns : journal of the International Society for Burn Injuries.

[23]  Mi-Yeon Kim,et al.  Evaluation of Natural Change of Skin Function in Split‐Thickness Skin Grafts by Noninvasive Bioengineering Methods , 2006, Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.].

[24]  H. Schaller,et al.  Comparing the Vancouver Scar Scale With the Cutometer in the Assessment of Donor Site Wounds Treated With Various Dressings in a Randomized Trial , 2006, Journal of burn care & research : official publication of the American Burn Association.

[25]  S. Pocock,et al.  Reporting of noninferiority and equivalence randomized trials: extension of the CONSORT 2010 statement. , 2006, JAMA.

[26]  P. V. van Zuijlen,et al.  The Patient and Observer Scar Assessment Scale: A Reliable and Feasible Tool for Scar Evaluation , 2004, Plastic and reconstructive surgery.

[27]  P. V. van Zuijlen,et al.  Skin elasticity meter or subjective evaluation in scars: a reliability assessment. , 2004, Burns : journal of the International Society for Burn Injuries.

[28]  K. Kiyokawa,et al.  Cryopreserved cultured epidermal allografts achieved early closure of wounds and reduced scar formation in deep partial-thickness burn wounds (DDB) and split-thickness skin donor sites of pediatric patients. , 2001, Burns : journal of the International Society for Burn Injuries.

[29]  W. Kuri-Harcuch,et al.  Controlled clinical study of deep partial-thickness burns treated with frozen cultured human allogeneic epidermal sheets. , 2000, The Journal of burn care & rehabilitation.

[30]  A. Gosain,et al.  Biomechanical Evaluation of Titanium, Biodegradable Plate and Screw, and Cyanoacrylate Glue Fixation Systems in Craniofacial Surgery , 1998, Plastic and reconstructive surgery.

[31]  F Kainberger,et al.  Lactosorb panel and screws for repair of large orbital floor defects. , 1997, Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery.

[32]  J. Laws State-of-the-art burn treatment. , 1996, Occupational health & safety.

[33]  M. Baryza,et al.  The Vancouver Scar Scale: an administration tool and its interrater reliability. , 1995, The Journal of burn care & rehabilitation.

[34]  E. Deitch,et al.  Hypertrophic burn scars: analysis of variables. , 1983, The Journal of trauma.

[35]  R F Edlich,et al.  The abbreviated burn severity index. , 1982, Annals of emergency medicine.

[36]  N. Modiano The Children. , 1898 .

[37]  Douglas G Altman,et al.  Reporting of noninferiority and equivalence randomized trials: an extension of the CONSORT statement. , 2006, JAMA.

[38]  R. Koller,et al.  The use of allogeneic cultivated keratinocytes for the early coverage of deep dermal burns – indications, results and problems , 2004, Cell and Tissue Banking.

[39]  R. Kreis,et al.  Expansion techniques for skin grafts: comparison between mesh and Meek island (sandwich-) grafts. , 1994, Burns : journal of the International Society for Burn Injuries.