Autologous skin substitute for hard-to-heal ulcers: retrospective analysis on safety, applicability, and efficacy in an outpatient and hospitalized setting.
Chronic ulcers ((arterio)venous, decubitus, or postoperative) have no tendency to heal within a period of at least 3 months despite optimal therapy according to internationally accepted guidelines. This retrospective study evaluates the safety and efficacy of an autologous, dermal-epidermal skin substitute (SS) for treating ulcers of various origins. Ulcers were treated within 7 Dutch centers over 5 years. Sixty-six ulcers (size: 0.75-150 cm²; duration: 0.25-32 years) with a follow-up time of 24 weeks after a single-skin substitute application were assessed. Wound-bed preparation consisted of vacuum-assisted-closure-therapy (5 days, hospitalized) or application of acellular dermis (5-7 days, outpatient). Time to heal, adverse events, and recurrence 1 year after complete healing were recorded. Complete ulcer healing occurred in 36 of 66 ulcers (55%) at 24 weeks. At that time point, a further 29% of ulcers showed decrease in ulcer size between 50 and 99%. No difference was observed between the hospitalized vs. outpatient treatment with complete healing. There were 32 of 36 healed ulcers that were available for follow-up 1 year after complete closure, of which 27 (84%) were still closed. Only two minor/moderate possibly related adverse events were recorded. This retrospective analysis shows that SS provides a safe and successful treatment for particularly chronic ulcers of various origins.
Department of Dermatology, VU Medical Center, Amsterdam, The Netherlands.
Chantal S
CS
Blok
Liselot
L
Vink
Edith M
EM
de Boer
Catherine
C
van Montfrans
Henk M
HM
van den Hoogenband
Michael C
MC
Mooij
Stefanie A
SA
Gauw
Jos A F P M
JA
Vloemans
Ineke
I
Bruynzeel
Aleid
A
van Kraan
Joop
J
Kuik
Taco
T
Waaijman
Rik J
RJ
Scheper
Susan
S
Gibbs
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000553:Ambulatory Care / Q000706:statistics & numerical data*; D002908:Chronic Disease; D005260:Female; D005500:Follow-Up Studies; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009426:Netherlands / Q000453:epidemiology; D010045:Outpatients / Q000706:statistics & numerical data; D012189:Retrospective Studies; D017768:Skin, Artificial; D013997:Time Factors; D016896:Treatment Outcome; D014456:Ulcer / Q000453:epidemiology / Q000503:physiopathology / Q000628:therapy*; D014945:Wound Healing