EpiDex® Swiss field trial 2004-2008.
BACKGROUND
Approximately 20% of leg ulcers remain unresponsive to the best conservative standard of care. So far, these patients could either receive conventional skin grafts or had to accept their intractable wound. Skin substitutes from cell culture may represent a promising alternative to heal a major part of these patients on a non-surgical, potentially more cost-effective basis.


OBJECTIVE
To systematically evaluate the first 68 patients treated in Switzerland (Swiss EpiDex® field trial 2004-2008).


METHODS
Retrospective study on EpiDex treatment of a complete consecutive series of 68 patients with chronic wounds (66 chronic leg ulcers, 2 sores) unresponsive to best conservative standard of care. The primary end point was complete wound closure within 9 months after transplantation, the secondary end points change of wound surface area, pain reduction and overall judgement by the patient. Adverse effects were infection, dermatitis and others. Calculation of treatment costs was made.


RESULTS
By the end of the study, 50/68 (74%) of patients had their wound completely healed [venous 29/37 (78%); mixed 7/9 (78%); others 14/22 (64%)]; 10/68 (15%) had the wound surface area reduced by >50%, and 8/68 (12%) did not respond to the EpiDex treatment. Wound pain disappeared completely in 78% and partially in 13%. Fifteen patients (22%) received antibiotics for wound infection, and 2 (3%) developed dermatitis (not related to the local therapy). Average treatment costs for venous ulcers amounted to EUR 5,357, compared to EUR 5,722-8,622 reimbursed according to the German DRG system (2010) for an in-patient skin graft.


CONCLUSIONS
EpiDex may effectively heal up to three quarters of recalcitrant chronic leg ulcers. Thus, it represents an intermediate step to avoid costly in-patient split-skin mesh graft treatments. Patients remain mobilized, and a donor site is avoided. Large wound size or a necrotic wound bed limit the use of EpiDex. Otherwise, it offers the opportunity to avoid conventional skin grafts in a significant number of chronic leg ulcer patients.
Department of Dermatology, University Hospital of Zürich, Zürich, Switzerland.
Natalie
N
Ortega-Zilic
Thomas
T
Hunziker
Severin
S
Läuchli
Dieter O
DO
Mayer
Clarissa
C
Huber
Katrin
K
Baumann Conzett
Kirstin
K
Sippel
Luca
L
Borradori
Lars E
LE
French
Jürg
J
Hafner
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D015331:Cohort Studies; D003872:Dermatitis / Q000191:economics; D005260:Female; D006801:Humans; D007871:Leg Ulcer / Q000191:economics / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010146:Pain / Q000191:economics; D059408:Pain Management; D012189:Retrospective Studies; D016038:Skin Transplantation / Q000191:economics; D017768:Skin, Artificial; D013557:Switzerland; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000191:economics / Q000628:therapy*; D058106:Wound Closure Techniques / Q000191:economics; D014945:Wound Healing; D014946:Wound Infection / Q000188:drug therapy / Q000191:economics / Q000628:therapy*; D055815:Young Adult