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. 2013 Jun 6;2013(6):CD008738. doi: 10.1002/14651858.CD008738.pub2

Soroff 1994.

Methods Study design: pilot study.
Setting/location: hospital (Hospital Institutional Review Board, Minnesota). Country: USA.
Period of study: not stated (published in 1994).
Unit of randomisation: burn wound.
Unit of analysis: burn wound.
Sample size calculation: no.
Use of ITT analysis?: no.
Participants Inclusion criteria:
1. Age: ≥ 18 years.
2. Partial‐thickness burns (defined as partial destruction of the dermal layer with dead tissue adherent to underlying viable dermis).
3. Two wounds of similar size and severity (noncontiguous).
Exclusion criteria:
1. Chemical or electrical burns.
2. Burns ≥ 25% TBSA.
3. Known hypersensitivity to collagenase, silver sulfadiazine, polymyxin B sulfate, or bacitracin.
4. Pregnant or breastfeeding women.
Randomised: 15 patients (30 burn wounds).
Excluded (post‐randomisation): 2 (13.3%).
Reason for exclusion: refused treatment (1); had an infection at an unrelated burn site (1).
Assessed: 13 patients (86.6%).
Age (years): not stated.
Gender (male: female): 14 (93.3%): 1 (6.6%).
Burned surface (% TBSA): (mean, SD): 11.7 ± 9.7 (range 2%‐34%).
TBSA full thickness burns: > 25% TBSA: 1 (34%), 1 (30%).
Inhalation injury: not stated.
Time post‐burn (h): not stated.
Burn type: scald (hot liquid or steam) 5 (33.3%), fire (flame) 5 (33.3%), other agents (hot ashes, flash, combined flame/flash) 5 (33.3%).
Wounds infected at baseline?: no.
Co‐morbidity: not described.
Interventions Type of antibiotic prophylaxis: topical antibiotic prophylaxis.
Type of interventions: polymyxin B sulfate/bacitracin vs SSD.
Group 1 (1st burn site): polymyxin B sulfate/bacitracin spray, covered with collagenase ointment, topically administered twice daily.
 Group 2 (2nd burn site): SSD cream, topically administered twice daily .
Before treatment wound cultures were taken, and burns cleansed with normal saline solution.
Duration of intervention: until wound bed was clean (disappearance of injured dermis).
Co‐interventions: not described.
Outcomes Time to wound healing.
Adverse events.
Notes In total, only 15 patients for both treatment groups were treated for different, non‐contiguous wounds.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Two noncontiguous burns of similar size and severity were treated according to a randomisation schedule" (Page 13 trial report).
Comment: insufficient information provided to make a judgement.
Allocation concealment (selection bias) Unclear risk No information provided.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No information provided (probably an open trial due to the different natures of the interventions (spray + ointment versus cream).
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Blinding of outcome assessors not reported, and probably not done, because of the different natures of the interventions (spray + ointment versus cream).
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 13/15 (87%) and 13/15 burn wounds (87%) in the collagenase and in the control groups, respectively, were included in the final analysis. Incomplete outcome data probably did not distort the study results.
Selective reporting (reporting bias) High risk No protocol provided, and none of the outcomes reported were listed in the methods section of the trial report.
Other bias Low risk The basal characteristics of participants did not present significant differences between comparison groups.