[A double blind randomised clinical trial to assess the efficacy of the treatments of the superficial pressure sores].
In spite of the progresses of knowledge and care, pressure sores continue to be a clinically relevant problem. A double blind randomised controlled trial was organised to assess the efficacy of triticum vulgaris (Fitostimoline) vs placebo in the re-epithelisation of superficial pressure sores. Patients with stage NPUAP II or superficial pressure sores, with an expected survival of more than 3 months and eligible for a follow-up up to 8 weeks were included, over a period of 2 years in 46 clinical sites. The protocol was approved by local ethical committees and informed consent was obtained before randomisation. Medications were performed by nurses if the patient was hospitalised and by nurses or properly instructed caregivers at home. Weekly follow-up controls were assumed by nurses. Out of the 294 randomised patients 270 were included in the analyses. The two groups are comparable for the main characteristics except for Norton Scale mean values, less severe in the group assigned to active treatment (10.1+/-3.7 vs 8.9+/-3.2). The mean follow-up was of 3.8 and 4.2 weeks with a mean duration of 26+/-18 and 29+/-18 days for the experimental group and controls respectively. Seventy-six patients in the treatment group and controls (58.0 and 54.7) had their lesions re-epithelized. Adjusting results for age, initial Norton and Push scores there are no differences between treated and controls (OR 0.99 95% IC 0.60-1.67). This multicentre study, sponsored by a research group of nurses, failed to support the hypothesis that triticum vulgaris, the active component of the product Fitostimoline, given on top of recommended treatment, provides a specific therapeutic advantage in terms of frequency and timing of re-epithelization in superficial pressure sores.
Di Giulio
Paola
P
Saiani
Luisa
L
Laquintana
Dario
D
Palese
Alvisa
A
Perli
Serena
S
Andreatta
Mariarosa
M
Rosa
Federica
F
Chini
Patrizia
P
Soraperra
Francesca
F
Ventura
Ida
I
Suriani
Cinzia
C
Romani
Silvia
S
Zancarli
Miriam
M
Martini
Marta
M
Partel
Francesca
F
Bassetti
Serena
S
Kaisermann
Rita
R
Bortolotti
Chiara
C
Gianordoli
Mirta
M
Rizzoli
Ilaria
I
Nardelli
Roberta
R
Pellizzari
Enrico
E
Valduga
Edda
E
Castaman
Marta
M
Pordenon
Marta
M
Beltrame
Moira
M
Bertolo
Cecilia
C
Casasola
Eleonora
E
Del Pin
Patrizia
P
Giolo
Simonetta
S
Marcatti
Emanuele
E
Pecini
Dina
D
Rodaro
Marisa
M
Zanon
Cristina
C
Stefanon
Laura
L
Covre
Lidia
L
Babbo
Consuela
C
Martin
Irma
I
Roilo
Antonia
A
Zanutel
Marta
M
Sabbadin
Silvano
S
Boin
Laura
L
Caron
Alessia
A
Martignago
Egidio
E
Venturin
Valter
V
Greggio
Annalisa
A
Frigo
Paola
P
Lazzaron
Daniela
D
Tonietto
Annalisa
A
Zanin
Barbara
B
Zorzi
Silvano
S
Zuanon
Antonio
A
Salmaso
Daniele
D
Frison
Tiziana
T
Marin
Irene
I
Buosi
Antonella
A
Fiorese
Elena
E
Gasparin
Dino
D
Goat
Barbara
B
Saccardo
Graziella
G
Simonetto
Ornella
O
Gomiero
Silvio
S
Baccara
Nicoletta
N
Ghirardello
Lucia
L
Niolu
Marilena
M
Silvestri
Sabrina
S
Buffon
Maria Luisa
ML
Casson
Paola
P
Santantonio
Rosy
R
Albore
Piersandro
P
Mazzorana
Elvira
E
Terziariol
Laura
L
Bulgarelli
Giuliana
G
Barani
Elisa
E
Gasparini
Patrizia
P
Migliori
Salvina
S
Sasso
Elisa
E
Marfisi
Rosa Maria
RM
Tognoni
Gianni
G
Sgaroni
Guya
G
Noro
Gabriele
G
Mattiuzzo
Mara
M
D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D006801:Humans; D008297:Male; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D003668:Pressure Ulcer / Q000188:drug therapy*; D014908:Triticum
D028321:Plant Preparations