title: A prospective, multi-centre, randomised, open label, parallel, comparative study to evaluate effects of AQUACEL® Ag and Urgotul® Silver dressing on healing of chronic venous leg ulcers.
abstract: This study compared wound healing efficacy of two silver dressings, AQUACEL(®)  Ag and Urgotul(®)  Silver, against venous ulcers at risk of infection, over 8 weeks of treatment. The primary objective was to show non inferiority of AQUACEL(®)  Ag to Urgotul(®)  Silver. Patients (281) were randomised into two groups. The AQUACEL(®)  Ag group had 145 patients treated with AQUACEL(®)  Ag for 4 weeks followed by AQUACEL for another 4 weeks. TheUrgotul(®)  Silver group had 136 patients treated with Urgotul(®)  Silver for 4 weeks followed by Urgotul(®)  for another 4 weeks. In both groups, ulcer size and depth, safety events and ulcer healing were compared. After 8 weeks of treatment, the AQUACEL(®)  Ag group had a relative wound size reduction (49·65% ± 52·53%) compared with the Urgotul(®)  Silver group (42·81% ± 60·0%). The non inferiority of the AQUACEL(®)  Ag group to the Urgotul(®)  Silver group was established based on the difference between them (6·84% ± 56·3%, 95% confidence interval -6·56 to 20·2) and the pre-defined non inferiority margin (-15%). Composite wound healing analysis showed that the AQUACEL(®)  Ag group had statistically higher percentage of subjects with better wound progression (66·9% versus 51·9%, P = 0·0108). In general, both dressings were effective at promoting healing of venous ulcers.
authors: Department of Dermatology & Wound Healing, School of Medicine, Cardiff University, Cardiff, UK. hardingkg@cardiff.ac.uk
authors: Keith
authors: K
authors: Harding
authors: Finn
authors: F
authors: Gottrup
authors: Arkadiusz
authors: A
authors: Jawień
authors: Jacek
authors: J
authors: Mikosiński
authors: Krystyna
authors: K
authors: Twardowska-Saucha
authors: Sławomir
authors: S
authors: Kaczmarek
authors: Maciej
authors: M
authors: Sopata
authors: Cliff
authors: C
authors: Shearman
authors: Alaine
authors: A
authors: Pieronne
authors: Dheerendra
authors: D
authors: Kommala
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D047070:Bandages, Hydrocolloid; D002266:Carboxymethylcellulose Sodium / Q000008:administration & dosage*; D002908:Chronic Disease; D004337:Drug Carriers; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018030:Silver Compounds / Q000008:administration & dosage* / Q000627:therapeutic use; D016896:Treatment Outcome; D014647:Varicose Ulcer / Q000188:drug therapy* / Q000473:pathology; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D004337:Drug Carriers; D018030:Silver Compounds; D002266:Carboxymethylcellulose Sodium