Caruso 2006.

Methods	Study design: prospective, randomised study. Setting/location: hospital (8 burn centres ‐ see notes for details). Country: USA. Period of study: January 2003‐September 2004 (1.8 years). Unit of randomisation: patient. Unit of analysis: patient. Sample size calculation: yes. Quote: "A sample size of at least 82 patients was selected to obtain a minimum of 64 evaluable patients" (Page 301 trial report). Use of ITT analysis?: no, Quote: "In the AQUACEL® Ag dressing group, all 42 patients were included in the safety and intent‐to‐treat analyses. In the silver sulfadiazine group, 40 of 42 patients were included in the safety and intent‐to‐treat analyses because 2 patients did not receive study treatment" (Page 301 trial report).
Participants	Inclusion criteria: 1. Patients with burn injuries acquired within 36 h preceding enrolment. 2. Age: ≥ 2 months. 3. Partial‐thickness burns, superficial burns, mid‐dermal, or mixed partial‐thickness burns. 4. 5%‐40% TBSA Exclusion criteria: 1. Electrical or chemical burns, or burns caused by frostbite. 2. Antibiotic taken during 2 days preceding burn injury. 3. Evidence of inhalation injury. 4. Fractures and/or neurological injury. 5. Treatment of the burn with an active agent (e.g. SSD) before study entry. 6. Pregnant. 7. Deep‐partial burns or full‐thickness burns (i.e. areas likely to require excision and grafting). Randomised: 84 patients (Group 1: n = 42, Group 2: n = 42). Excluded (post‐randomisation): Group 1: 2 (5%). Reason for exclusion: these 2 patients did not receive study treatment. Patients assessed: 82 patients (97.6%) (Group 1: n = 40 (95%) Group 2: n = 42 (100%)). Age (years): (mean, range): Group 1: 24 (0.5‐76.5), Group 2: 29.4 (0.8‐80.6). Gender (male: female): Group 1: 30 (75%): 10 (25%), Group 2: 27 (64%): 15 (36%). Burned surface (% TBSA): (mean, range): Group 1: 10.8% (5.0‐27.5%), Group 2: 12% (5.0‐35.0%). Inhalation injury: none. Time post‐burn (h): (mean, range): Group 1: 5.5 (0.0‐18.7), Group 2: 7.2 (1.0‐49.5). Burn type: Group 1: scald (hot liquid or steam) 18 (45%), fire (flame) 8 (20%), contact (hot solids) 1 (2.5%), other (several agents) 13 (32.5%); Group 2: scald 27 (64.3%), fire 4 (9.5%), other 11 (26.19%). Wounds infected at baseline?: no. Co‐morbidity: not described.
Interventions	Type of antibiotic prophylaxis: topical antibiotic prophylaxis. Type of interventions: SSD vs Ag dressing. Group 1: SSD 1% cream topically once daily. Group 2: AQUACEL® Ag dressing (ConvaTec, a Bristol‐Myers Squibb company, Skillman, NJ) topically every 2‐3 days. Duration of intervention: 21 days, or until complete re‐epithelialization. Co‐interventions: not stated.
Outcomes	Rate of full re‐epithelialization (healing was defined as either 100% re‐epithelialization, or within 21 days). Time to complete wound healing (days). Adverse event (defined as any untoward medical occurrence that was new, or worsened during the study). Infection. Wound infection. Mortality.
Notes	Sources of support: Quote: "This study was supported by a grant from ConvaTec, a Bristol‐ Myers Squibb company" (Page 298). "Study centers were compensated for performing the study, and ConvaTec provided AQUACEL® Ag dressing and SSD. Patients were not compensated for their participation. ConvaTec supervised the design of the study, the data analyses, and the development of the manuscript" (Page 309 trial report). Note on Methods section (above): Arizona Burn Center, Phoenix, Arizona; Lehigh Valley Hospital, Allentown, Pennsylvania; Hennepin County Medical Center, Minneapolis, Minnesota; Shriners Burns Hospital‐Galveston, Galveston, Texas; University of South Alabama Medical Center, Mobile, Alabama; Integris Baptist Medical Center, Oklahoma City, Oklahoma; Los Angeles County and University of Southern California Medical Center, Los Angeles, California; New York‐Presbyterian Hospital, New York.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were assigned randomly to a protocol of care that included either AQUACEL® Ag dressing or silver sulfadiazine. The randomisation schedule was stratified by extent of burns (5% to 20% or > 20% to 40% of TBSA) and age (0–3 years or 4 years and older)" (Page 299 trial report). Quote: "Baseline characteristics were comparable between treatment groups (Table 1)" (Page 301 trial report). Comment: insufficient information to make a judgement.
Allocation concealment (selection bias)	Unclear risk	No information provided.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Study treatment was not blinded" (Page 299 trial report).
Blinding of outcome assessment (detection bias) All outcomes	High risk	No blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	42/42 (100%) and 40/42 patients (95%) in the AQUACEL Ag dressing and in the SSD group, respectively, were included in the final analysis. Although a per protocol analysis was performed (2 participants from the SSD group were excluded due to not having received study treatment), it probably did not bias the results of the study.
Selective reporting (reporting bias)	Low risk	No protocol provided, but given the outcomes listed in the methods section, all pre‐specified outcomes were reported.
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias existed.