Dimakakos 2009;227 Greece; RCT
No information about methods of randomisation, allocation concealment or blinding; healing data analysed by intention to treat
Funder not stated | 42 patients with venous leg ulcers (confirmed by Doppler) randomised. All ulcers were infected at baseline. Baseline wound size and duration reported but no mention of primary/recurrent ulceration | Group 1: silver foam dressing (Contreet®, Coloplast) (n = 21; group 2: non-adhesive foam dressing (Biatain®, Coloplast) (n = 21)
All patients received short-stretch bandage. Dressings were changed twice weekly. Some patients received antibiotics. Treatment duration was 9 weeks | Complete healing at 5 weeks: group 1: 8/21 (38%); group 2: 4/21 (19%)
Complete healing at 9 weeks: group 1: 17/21 (81%); group 2: 10/21 (48%)
Healing also shown at 3, 4, 6, 7 and 8 weeks in a table
Data on bacterial load were reported
Other outcomes: pain, exudation, adverse events
No withdrawals for healing data |
Jørgensen 2005;228 Canada Denmark, Germany, Italy, The Netherlands, UK, USA; RCT
Computer-generated block randomisation used; allocation concealment not described; outcome assessment non-blind; safety analysis was by intention to treat and efficacy analysis was per protocol
Funded by Coloplast A/S, Humlebaek, Denmark | 129 patients with moderately or highly exuding venous or mixed venous/arterial leg ulcers were randomised. Minimum ulcer area was 2 cm2. Ulcers were ‘critically colonised’ at baseline (definition provided) but not clinically infected (this was an exclusion criterion). Baseline wound size and duration reported but no information about primary/recurrent ulceration | Group 1: silver-release foam dressing (Contreet) (n = 65); group 2: polyurethane foam dressing (Allevyn; S&N) (n = 64)
Compression therapy described as ‘mandatory’ according to clinical practice of study centres (modification of compression for those with mixed disease not described). Some patients received topical steroids to peri-ulcer skin. Dressings and bandages were changed weekly. Treatment duration was 4 weeks | Complete healing at 4 weeks (per protocol): group 1: 5/52 (10%); group 2: 5/57 (9%)
Time to healing not reported
Assessment of infection not reported (patients requiring systemic antibiotics were excluded from the per-protocol analysis)
Other outcomes: absolute and relative change in ulcer area; odour; exudate; quality of life; dressing performance; adverse events
Withdrawals: 20 in total (16%) |
Lazareth 2008;229 France; RCT
Block randomisation was used; allocation concealment by sealed envelopes; outcome assessment not blind but assessments retrospectively checked by blinded investigators; analysis was by intention to treat; population defined as randomised patients with at least one follow-up assessment for wound size
Funded by URGO Laboratories, France | 102 patients with venous leg ulcers (ABPI > 0.8) of duration < 24 months and surface area 5–40 cm2 were randomised. In addition, leg ulcers had to have at least three of five clinical signs of ‘high bacterial load’ (pain, erythema, oedema, odour, exudation). At baseline, all patients had clinical signs of high bacterial load but clinical infection and current/recent antibiotic use were exclusion criteria. Baseline wound size, duration and ulcer status (primary or recurrent) were reported | Group 1: silver dressing (non-adhesive, non-occlusive dressing – proprietary name not stated) (n = 52); group 2: dressing as above but not containing silver (n = 50)
All patients received compression (details not given). Dressings and bandages were changed every other day or less frequently. Treatment duration for randomised comparison was 4 weeks (all patients received the non-silver dressing between weeks 4 and 8) | Dichotomous healing data not reported, nor time to healing
Main outcome was mean ± SD (median) change in ulcer area at 4 weeks (cm2): group 1: –6.5 ± 13.4 (4.2); group 2: –1.3 ± 9.0 (1.1) (p = 0.023)
Other outcomes: healing rate (cm2/day); probability of achieving 40% area reduction; local signs of heavy bacterial colonisation; adverse events
Withdrawals at 8 weeks: group 1: 8/52 (15%); group 2: 20/50 (40%) |
Meaume 2005;230 France; RCT
Randomisation stratified according to wound type; allocation concealment not mentioned; outcome assessment not blind; analysis by intention to treat
Funded by Johnson & Johnson Wound Management | 101 patients with venous leg ulcers and pressure ulcers were randomised (99 patients analysed). Wounds were colonised but not clinically infected at baseline; recent systemic antibiotic use was an exclusion criterion. Baseline wound area, duration and whether primary or recurrent ulcers were reported | Group 1: silver-releasing hydroalginate dressing (Silvercel®, Systagenix) (n = 51; 38 with leg ulcers and 13 with pressure ulcers); group 2: non-silver calcium alginate dressing (Algosteril®, Smith & Nephew) (n = 48; 33 with leg ulcers and 15 with pressure ulcers)
All venous leg ulcer patients received compression. Dressings were changed every few days. Treatment duration was 4 weeks | Dichotomous healing data not reported, nor time to healing
Main outcome was mean ± SD change in ulcer area (cm2) – results for leg ulcers only: group 1: –9.5 ± 17.9; group 2: –6.0 ± 11.7 (p = 0.117)
Other outcomes: percentage change in ulcer area; healing rate (cm2/day); use of systemic antibiotics during the trial; number of wounds developing clinical infection; adverse events
Withdrawals: group 1: 10/51 (20%); group 2: 9/48 (19%) |
Michaels 2009;231 UK; pragmatic RCT
Computer-generated block randomisation with stratification according to ulcer size and treatment centre; allocation concealment not described; methods of outcome assessment not reported (but unlikely to be blind); analysis was by intention to treat
Funded by UK NIHR Health Technology Assessment programme | 213 patients with venous leg ulcers (ABPI ≥ 0.8, wound duration > 6 weeks, maximum wound diameter < 1 cm) were randomised. Recent use of antibiotics was an exclusion criterion. Baseline ulcer size/duration and primary/recurrent ulceration were reported | Group 1: silver-releasing dressing according to clinicians’ choice [most commonly Urgotul SSD (Urgo), Acticoat 7 (S&N), Aquacel Ag (S&N) or Contreet foam] (n = 107); group 2: non-adherent, non-antimicrobial dressing from any manufacturer according to clinicians’ choice (most patients received low-adherence knitted viscose dressings) (n = 106)
All patients received multilayer compression (choice of bandage according to local practice). Dressings/bandages were changed weekly or more often if required. Treatment duration was 12 weeks. After 12 weeks the randomised treatment could be changed or stopped, according to the clinicians’ judgement | Complete healing at 12 weeks (n = 208 analysed): group 1: 62/104 (59.6%); group 2: 59/104 (56.7%) (p = 0.673)
Complete healing at 6 months (n = 203 analysed): group 1: 87/102 (85.3%); group 2: 78/101 (77.2%) (p = 0.141)
Complete healing at 12 months (n = 193 analysed): group 1: 95/99 (96.0%); group 2: 90/94 (95.7%) (p = 0.940)
Median days to healing: group 1: 67 (95% CI 54 to 80); group 2: 58 (95% CI 43 to 73) (p = 0.408) (Cox proportional hazards model)
Other outcomes: ulcer recurrence at 6 and 12 months (no difference between groups); adverse events; quality of life (EQ-5D and SF-36); costs; resource use; cost-effectiveness |
Münter 2006;232 Germany, UK, Denmark, Italy, Switzerland, Belgium, Slovenia, Brazil, Canada; pragmatic RCT
Computer-generated block randomisation; sealed envelopes; outcome assessment not blind; analysis by intention to treat (last observation carried forward)
Funded by Coloplast A/S, Humlebaek, Denmark | 619 patients with various chronic wounds were randomised (burns, donor sites, surgical, leg ulcers, pressure ulcers, diabetic foot ulcers). Clinical infection of the wound was not an exclusion criterion. Baseline wound area and duration were reported but primary/recurrent ulceration not mentioned | Group 1: sustained silver-releasing foam dressing (Contreet Foam) (n = 326 overall; 218 with venous/mixed leg ulcers); group 2: local best practice (included various alternative dressings including silver) (n = 293 overall; 197 with venous/mixed leg ulcers)
Compression given to leg ulcer patients in line with local practice. Dressings and bandages changed at least weekly. Treatment duration was 4 weeks | No report of dichotomous healing or time to healing
Median % reduction in ulcer area for all leg ulcers (n = 415 analysed): group 1: 45.5%; group 2: 28.8% (p = 0.0001); for venous leg ulcers (a subset of the above – n = 297 analysed): group 1: 46.2%; group 2: 26.9% (p = 0.0001)
Other outcomes: % slough; wound progress; peri-ulcer skin/maceration; exudate; ease of dressing use; odour; pain; time spent on dressing change; mean wear time of dressing; quality of life
Withdrawals not described |
Wunderlich 1991;233 Germany; RCT
Methods of randomisation and allocation concealment not stated; outcome assessment not blind; analysis not by intention to treat
Funder not stated | 40 patients with venous leg ulcers were randomised. No mention of ulcer infection status at baseline. Baseline ulcer area and duration were reported; no mention of primary/recurrent ulceration | Group 1: silver-impregnated charcoal dressing (Actisorb Plus; J&J) used for all stages of wound healing (n = 20); group 2: various topical agents used; if wound in granulation phase, mineral oil or povidone iodine/sea salt paste was used, whereas if in epithelialisation phase, paraffin-impregnated gauze or oil and water emulsion was used (n = 20)
All patients received debridement initially and throughout the trial as required. No mention of compression. Treatment duration was 6 weeks | Complete healing at 6 weeks: group 1: 6/19 (32%); group 2: 2/19 (11%). Between-group difference reported as not significant
Other outcomes: mean ulcer size at 6 weeks; percentage reduction in ulcer area at 2, 4 and 6 weeks
Withdrawals: one patient per group |
