FOURTEENTH ANNUAL EUROPEAN PRESSURE ULCER ...

Thursday September 1st
Proceedings of the 14th Annual European Pressure Ulcer Meeting
Oporto, Portugal
Retrospective analysis of patients with ulcers of (arterio-)venous, traumatic or decubitus origin
treated with autologous skin substitute
C.M.A. Reijnders 1 , L. Vink 1,2 , C.S. Blok 1 , R.J. Scheper 1,2 , C. van Montfrans 1 , E.M. de Boer 1,2 , S. Gibbs 1*,2
1* VUmc, Netherlands, s.gibbs@vumc.nl; 2 A-Skin BV, Netherlands,
Introduction
We have developed an autologous full thickness living
skin substitute consisting of reconstructed epidermis
on fibroblast populated human dermis (SS) (Fig. 1).
The SS is constructed from very small (3 mm
diameter) punch biopsies of healthy skin taken from
the patient during routine visits to the out patient clinic.
The time taken to culture the SS is 3 weeks. The aim
of this retrospective study was to evaluate the safety,
efficiency and applicability of the SS together with the
transferability of the protocol between different centres
for treating chronic, hard to heal ulcers in an out
patient as well as a hospitalized setting. The
recurrence rate one year after complete healing was
also assessed. Ulcers of (arterio-)venous (venous with
in some cases an arterial component), post-traumatic
or decubitus origin were treated in multiple studies
between 2004 and 2009 in 7 Dutch centres.
Methods
Retrospectively a series of 5 studies (i) pilot, ii)
insurance initiated, iii) nursing home, iv) individual
case studies and v) an interim multicentre trial) were
analysed. Ulcers of varying location, size and aetiology
(e.g. (arterio-)venous insufficiency, post-traumatic,
decubitus) were included. Sixty six ulcers (54 patients;
ulcer size: 0.75-150 cm 2 ; duration: 0.25- 32 years) with
a minimum follow-up time of 24 weeks after SS
application were assessed. Wound-bed preparation
consisted of vacuum-assisted-closure-therapy (5 days,
hospitalized) or application of acellular dermis (5-7
days, ambulatory). Patients received one application of
SS followed by weekly evaluation and wound
treatment. Time to heal, adverse events and
recurrence rate one year after complete healing were
recorded.
Fig. 1: Full thickness autologous skin substitute
68
Results
Complete ulcer healing occurred in 41 of 66 ulcers (62
%). Ulcer size was significantly reduced at week 12
compared to week 0 and week 24 compared to week
12. At 12 weeks, ulcer size was significantly reduced
in the hospitalized group compared to the out patient
group. However after 24 weeks this difference
between hospitalized versus out patient treatment was
no longer observed. Ulcer recurrence was assessed 1
year after time to complete closure. From the 41
closed ulcers, 37 were available for follow-up, of which
thirty (81%) were still closed. Only one minor adverse
event was recorded (mild erythema of unknown cause
around the area of the skin substitute which was
successfully treated with systemic anti-histamine.
Discussion
This retrospective analysis shows that SS provides a
safe and successful treatment for particularly hard to
heal chronic ulcers of various origin. The protocol was
transferable to 7 Dutch centres. The SS could be
applied in an out patient setting making it more cost
effective and less time consuming than hospitalized
treatment.
Clinical relevance
Treatment for closure of hard to heal chronic skin
wounds
Acknowledgements
We appreciate the help of all specialists, wound-care
nurses and technicians involved in this study.
Participating centres were: Phlebologic Centre
Oosterwal, Nursing home Naarderheem, Groene Hart
Hospital, Nursing home Ter Gooi, Red Cross Hospital
Beverwijk, Waterland Hospital
Conflict of Interest
R.J. Scheper, E.M. de Boer and S. Gibbs are cofounders
of the university spin off company A-Skin
References
[1] Gibbs S, et al. Br J Dermatol 155: 267-74, 2006
[2] Spiekstra SW et al., Wound Repair Regen
15(5):708-17, 2007.
[3] Vriens AP et al., Cell Transplant 17(10-11):1199-
209, 2008.
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