Mohammadi 2009.

Methods	Study design: randomised clinical trial. Setting/location: hospital (Ghotbeddin Burn Hospital, Shiraz). Country: Iran. Period of study: October 2005‐February 2007 (16 months). Unit of randomisation: patient. Unit of analysis: patient. Sample size calculation: no. Use of ITT analysis?: unclear.
Participants	Inclusion criteria: 1. Patients with deep burns (2nd‐ and 3rd‐degree). 2. Burns over 20‐50% TBSA. 3. Patients admitted to burn centre. Exclusion criteria: 1. Age: > 60 years. 2. History of cardiac disease, renal failure, diabetes mellitus or any other severe metabolic disorder. Randomised: 124 patients (Group 1: n = 63, Group 2: n = 61). Excluded (post‐randomisation): Group 1 (control group): 1 (1.6%). Reasons for exclusion: Quote: "... an 18‐year‐old female, a case of suicide with 40% burn, who underwent amniotic membrane dressing. On the 5th day, the patient had high grade fever due to which her dressing was changed to regular antibiotic and gauze dressing. She was expired on the 14th day of hospitalization. This was the only case whose treatment policy was changed during hospitalization and so she was excluded from the survey". Withdrawals: Group 2: 5 (8.6%) (2 males and 3 females). Reasons: died during the study. Age (years): (mean): Group 1: 23.31 ± 14.53, Group 2: 25.3 ± 11.81. Gender (male: female): Group 1: 35 (55.5%): 28 (44.4%), Group 2: 35 (57.3%): 26 (42.6%). Burned surface (% TBSA): (mean): Group 1: 32.4% ± 8.9%, Group 2: 31.2% ± 8.3%. TBSA full thickness burns: Group 1: 63 (100%), Group 2: 61 (100%). Inhalation injury: not stated. Time post‐burn (h): not stated. Burn type: in both groups most common mechanism was flame followed by flash. Wounds infected at baseline?: no. Co‐morbidity: no comorbidity.
Interventions	Type of antibiotic prophylaxis: topical antibiotic prophylaxis. Type of interventions: amniotic membrane vs SSD. Group 1: amniotic membrane. Wounds were washed with normal saline and diluted Betadine and then covered with a layer of amniotic membrane, then a layer of Vaseline gauze, and a dressing with gauze and band. Placentas were acquired from elective caesarean sections. The amniotic membrane was separated from chorion and placenta and washed thoroughly with normal saline, kept in a sterile pot of normal saline plus 80 mg gentamycin, and stored in refrigerator at 4°C. A blood sample drawn from the umbilical cord was checked for syphilis (VDRL test), HIV, HCV, and HBS, and, only if all these tests were negative, was the amniotic membrane used. Dressings were changed every 3‐4 days. Group 2: SSD or mafenide acetate. Wounds were irrigated twice daily with normal saline and diluted Betadine and then covered with SSD, or in some cases mafenide acetate dressing. Duration of intervention: before skin graft (26 days). Co‐interventions: not described.
Outcomes	Wound infection. Sepsis (suspected as present with the following symptoms: signs of hypothermia, hypotension, abrupt hyperglycaemia, decreased urine output, thrombocytopenia and diet intolerance, including blood culture and urine culture). LOS (days). Mortality.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: " . . . were admitted in our center were randomly divided into two groups, using random allocation (regardless of the depth of the burn)" (Page 67 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	Unclear risk	Quote: "In this double‐blinded randomised clinical trial". Comment: it is not clear who was blinded.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Quote: "In this double‐blinded randomised clinical trial" Comment: it is not clear who was blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Comment: it is not clear how the authors considered the post randomisation exclusions and withdrawals in the analysis, however, due to their low number (6/124, i.e. 5%) they may have not distorted the study results.
Selective reporting (reporting bias)	High risk	No protocol provided, and some of the outcomes reported were listed in the methods section of the trial report.
Other bias	Unclear risk	Insufficient information to assess whether an important risk of bias existed.