| Efficacy and safety of the freeze-dried cultured human keratinocyte lysate, LyphoDerm 0.9%, in the treatment of hard-to-heal venous leg ulcers. | |
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MedLine Citation:
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PMID: 15828938 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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LyphoDerm (XCELLentis, Belgium) is an end-sterilized, freeze-dried lysate from cultured allogeneic epidermal keratinocytes, formulated into a hydrophilic gel. Its efficacy and safety were evaluated, in combination with standard care (hydrocolloid dressing and compression therapy), in 194 patients suffering from hard-to-heal (lasting more than 6 weeks and not responding to conventional therapy) venous leg ulcers. Two control groups received standard care, with or without vehicle, respectively. Patients had a median age of 67.5 years and the majority were females (61%). The median duration of the ulcer was 43 weeks and in 39% of the subjects it had been present for more than 1 year. Thirty-eight percent of the patients in the standard care + LyphoDerm group had complete ulcer healing within 24 weeks (primary end point) compared to 27% of patients in the standard care + vehicle pooled groups (P = 0.114) in the "as treated" intent-to-treat cohort (37% vs. 27% in the "as randomized intent-to-treat cohort; p = 0.137). In the subgroup of patients with enlarging ulcers, the difference between the two groups was significant (30% vs. 11%; p = 0.024 in the "as treated" intent-to-treat cohort and 31% vs. 9%; p = 0.005 in the "as randomized" intent-to-treat cohort). LyphoDerm was well tolerated and safe, and no differences in the frequency of adverse events were noted between the treatment groups. Although the primary objective of the study was not achieved, the exploratory analysis carried out in patients with enlarging ulcers suggests that LyphoDerm could offer a new prospect for the treatment of patients with venous ulcers that may prove to be a significant adjunct to the overall provision of care. |
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Authors:
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Keith G Harding; Thomas Krieg; Sabine A Eming; Mieke L F Flour; Arkadiusz Jawien; Andrzej Cencora; Andrzej Kaszuba; Wojciech Noszcyk; Peter Willems; Andy De Deene; Evelyne Joos; Peter De Waele; Bernard Delaey |
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Publication Detail:
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Type: Clinical Trial; Clinical Trial, Phase II; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society Volume: 13 ISSN: 1067-1927 ISO Abbreviation: Wound Repair Regen Publication Date: 2005 Mar-Apr |
Date Detail:
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Created Date: 2005-04-14 Completed Date: 2005-08-02 Revised Date: 2006-11-15 |
Medline Journal Info:
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Nlm Unique ID: 9310939 Medline TA: Wound Repair Regen Country: United States |
Other Details:
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Languages: eng Pagination: 138-47 Citation Subset: IM |
Affiliation:
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Department of Surgery, Wound Healing Research Unit, University of Wales, College of Medicine, Cardiff, United Kingdom. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Aged Aged, 80 and over Bandages Bandages, Hydrocolloid Cells, Cultured Female Freeze Drying Humans Keratinocytes* Male Middle Aged Skin, Artificial* Time Factors Treatment Outcome Varicose Ulcer / physiopathology*, therapy* Wound Healing |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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