title: Clinical trial of the temporary biosynthetic dermal skin substitute based on a collagen and hyaluronic acid named Coladerm H/HM, first part.
abstract: BACKGROUND
  This paper presents the results of the first part of the clinical study of temporary biosynthetic dermal skin substitute based a on collagen and hyaluronic acid, named Coladerm H/HM. The aim of this study was to evaluate safety and effects of Coladerm H/HM in covering the split-thickness skin graft donor sites in humans. This membrane was applied to a part of the split-thickness skin graft donor site; its effects and properties were compared to standard dressing used for covering the split-thickness skin graft donor sites at the Department of Burns and Reconstructive Surgery, University Hospital Bratislava, Slovakia, Dermazin® (Lek) + Acidum Aceticum 1% (magistraliter), which were applied together to the rest of the donor site.
  
  
  METHODS
  Twenty patients were randomly selected with the following criteria: age of 18-65 years, no severe accompanying diseases such as diabetes, renal failure, immune disorders, severe arteriosclerosis, severe allergic conditions. Evaluation was done according to the evaluation protocol.
  
  
  RESULTS
  Primary assessment showed that Coladerm H/HM does not influence the rate of epithelization from a long term point of view, but the initial faster epithelization contributes to the reduction of the risk of complications, which may arise from a long term open wounds. Secondary assessment showed the effect of Coladerm H/HM to the secretion of the wounds in the second inspection interval when the wound was dry in the whole group. Next, Coladerm H/HM contributed to the temporarily statistically significant positive effect to the color of donor area in the third inspection interval. Positive bacteriological finding occurred in one patient secondary. Analgetic effect of Coladerm H/HM assessed by a doctor was expressed as good in 70%. 95% of patients reported only mild pain after application of Coladerm H/HM. There were no significant side effects recorded, only 1 patient stated itching, which disappeared spontaneously. Application of Coladerm H/HM has positive properties for treating the split-thickness skin graft donor sites in humans.
  
  
  CONCLUSIONS
  Coladerm H/HM showed positive results covering the split-thickness skin graft donor sites in the first part of the clinical trial. Production of the Coladerm H/HM and its introduction into the clinical practice is planned after successful completion of all the parts of clinical trial.
authors.affiliation: Department of Plastic Surgery, City Hospital of T. Bat'a, Ltd., Zlin, Czech Republic. darina.potocka@gmail.com
authors.forename: D
authors.initials: D
authors.lastname: Potocká
authors.forename: D
authors.initials: D
authors.lastname: Kevická
authors.forename: J
authors.initials: J
authors.lastname: Koller
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001672:Biocompatible Materials; D003094:Collagen; D004848:Epithelium / Q000502:physiology; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid; D008297:Male; D008875:Middle Aged; D062326:Re-Epithelialization / Q000502:physiology*; D016038:Skin Transplantation; D017768:Skin, Artificial; D014945:Wound Healing; D014947:Wounds and Injuries / Q000503:physiopathology; D055815:Young Adult
chemical_list: D001672:Biocompatible Materials; D006820:Hyaluronic Acid; D003094:Collagen