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. |
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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. |
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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. |
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Outcomes | Time to wound healing. Adverse events. |
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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. |