Efficacy and tolerability of hyaluronan (ialuset) in the treatment of pressure ulcers: a multicentre, non-randomised, pilot study.
BACKGROUND
Pressure ulcers are complex chronic wounds and a frequent cause of morbidity in elderly subjects in hospitals and nursing homes. Local treatment is based on the use of dressings that protect the wound and provide a favourable environment for healing to occur. ialuset, a treatment based on hyaluronan (hyaluronic acid), is already available on the market and known to be an effective treatment for venous leg ulcers. However, no clinical trials of hyaluronan as a treatment option for pressure ulcers have been reported as yet.


METHODS
The purpose of this review was to investigate the efficacy and tolerability of ialuset in the treatment of pressure ulcers. To this end, this article reports data from 21 predominantly elderly patients with National Pressure Ulcer Advisory Panel grade II, III or IV pressure ulcers treated with ialuset cream or gauze pads over a 3-week period in ten hospitals in France.


RESULTS
A significant median decrease of 4cm2 in the surface area of treated wounds was observed after 3 weeks of ialuset use (p < 0.05 vs baseline). A >or=50% reduction in pressure ulcer surface area was seen in 65.0% of patients (95% CI 44.8, 84.3). Nine patients (45%) showed a >or=50% increase in epithelial surface compared with the initial lesion. Patient-reported pain appeared to decrease during the 3-week treatment period, although this decrease did not quite reach statistical significance (p = 0.07). Additionally, a significant decrease in the mean percentage of fibrous tissue in the wound was observed (p = 0.02), as was a non-significant increase in granulation tissue (p = 0.1). General efficacy was considered as good or very good for nearly all patients on review of the data (19/20 patients as assessed by clinicians). Overall tolerability was also considered good or very good in 12/15 assessments by patients at day 21.


CONCLUSIONS
These preliminary findings suggest that ialuset is a promising option in the treatment of pressure ulcers; however, further investigation in the form of large, randomised clinical trials is required before firm conclusions can be drawn regarding the efficacy and tolerability of this treatment in this context.
Barrois
Brigitte
B
Service de Médecine Physique et Réadaptation, Centre Hospitalier de Gonesse, Gonesse, France. Brigitte.barrois@ch-gonesse.fr
Carles
Muriel
M
Rumeau
Michel
M
Tell
Laurence
L
Toussaint
Jean-François
JF
Bonnefoy
Marc
M
de Vathaire
Florent
F
D000368:Aged; D005260:Female; D005602:France; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009779:Occlusive Dressings; D009824:Ointments; D010865:Pilot Projects; D003668:Pressure Ulcer / Q000188:drug therapy*; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects
D009824:Ointments; D006820:Hyaluronic Acid