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

Gotschall 1998.

Methods Study design: prospective, randomised, controlled clinical trial.
Setting/location: hospital (Children's National Medical Center, Washington). Country: USA.
Period of study: 1 November 1993‐31 December 1996 (3.1 years).
Unit of randomisation: patient.
Unit of analysis: patient.
Sample size calculation: no.
Use of ITT analysis?: unclear.
Participants Inclusion criteria:
1. Age: ≤ 12 years.
2. Admitted to the regional paediatric burn centre.
3. Partial‐thickness burns.
4. Scald burns (defined as burns resulting from hot non‐viscous fluids and did not include substances such as oatmeal or mashed potato).
5. Burns ≤ 15% TBSA
6. When the burns affected only were flat body surfaces.
Exclusion criteria:
1. Children suspected to be victims of child abuse.
2. History of allergy to silicone.
3. Chronic diseases that might affect the healing process (e.g. white blood cell deficiency).
Randomised: 63 children (Group 1: n = 33, Group 2: n = 30).
Withdrawals: children whose wounds converted to full‐thickness were withdrawn from the study.
Burned surface (% TBSA): (mean, SD):Group 1: 6.8% ± 3.4%, Group 2: 5.1% ± 2.2%.
Inhalation injury: not stated.
Time post‐burn (h): not stated.
Burn type: Group 1: scald (hot liquid or steam) 33 (100%); Group 2: scald (hot liquid or steam) 30 (100%).
Wounds infected at baseline?: no.
Co‐morbidity: not described.
Interventions Type of antibiotic prophylaxis: topical antibiotic prophylaxis.
Type of interventions: silicone mesh dressing vs SSD.
Group 1: silicon‐coated nylon dressing (Mepitel, Mölnlycke Health Care, USA).
 Group 2: SSD cream.
Gauzes wet and dry were applied under cotton gauze dressing over both treatment arms.
Duration of intervention: until complete healing.
Co‐interventions: not stated.
Outcomes Wound healing.
Healing time (measured by number of days until wounds were 25%, 50%, 75% and 100% epithelialized).
Burn wound infection (clinical data and swab culture).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Treatment was assigned randomly" (Page 280 trial report).
Quote: "There were no significant differences between the two groups with respect to age, sex, or race" (Page 280 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 It was not reported whether participants and personnel were blinded, but they were probably not, due to the different nature of the interventions.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "The principal Iimitation of this investigation is the lack of "blinding" to treatment assignment by the people assessing the wounds at the dressing changes" (Page 283 trial report).
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Did not report number of withdrawals.
Quote: ". . . children whose wounds had converted to full‐thickness were withdrawn from the study" (Page 280 trial report).
Comment: it is not clear whether the outcome data were incomplete.
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 Low risk The study appeared to be free of other sources of bias.