Maya 1986.
Methods |
Study design: randomised controlled trial. Setting/location: hospital (Hospital Infantil de Tacubaya de los Servicios Médicos del D.D.F.). Country: Mexico. Period of study: not stated (published in 1986). Unit of randomisation: patient. Unit of analysis: patient. Sample size calculation: no. Use of ITT analysis?: yes. |
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Participants |
Inclusion criteria: 1. Paediatric patients. 2. 2nd‐degree burns. 3. Patients admitted to the hospital. Exclusion criteria: not described. Randomised: 40 patients (Intervention group: n = 20, Control group: n = 20). Patients assessed: 40 patients (100%). Age (months): (mean, SD): Intervention group: 45.65 (26.87), Control group: 35.45 (26.44). Gender (male: female): Intervention group: 12 (60%): 8 (40%), Control group: 11 (55%): 9 (45%). Burned surface (% TBSA): (mean, SD): Intervention group: 12.25% (7.8), Control group: 12.65% (8). TBSA full thickness burns: Intervention group: 3 (15%), Control group: 2 (10%). Inhalation injury: not stated. Time post‐burn (h): (mean): Intervention group: 11.75 h, Control group: 14.87 h. Burn type: Intervention group: scald (hot liquid or steam) 17 (85%), fire (flame) 3 (15%); Control group: scald 16 (80%), fire 2 (10%), chemical 2 (10%). Wounds infected at baseline?: no. Co‐morbidity: not described. |
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Interventions |
Type of antibiotic prophylaxis: topical antibiotic prophylaxis. Type of interventions: rifamycin and amniotic membranes vs amniotic membranes. Intervention group: amniotic membranes and rifamycin. Rifamycin was sprayed over the amniotic membranes. Membranes were kept dry, and sprayed again with rifamycin in case of apparent discharge. Control group: amniotic membranes. Amniotic membranes were separated from the chorion. Then they were washed in 250 ml 0.9% saline solution plus 1 g of neomycin. Membranes were stored at 4ºC for 14 days. Cultures of control were conducted every five days to verify the absence of bacterial contamination. Afterwards, they were used for treatment. In both groups, once the membranes had been placed, they were stretched over the burn area and dried with a hair dryer. In case of slippage or infection, the amniotic membranes were changed. Duration of intervention: until wound healing (16 days). Co‐interventions: mechanical wash with Isodine and debridement of necrotic tissue, including blisters. Fluid replacement. |
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Outcomes | LOS (days) Wound infection Time to re‐epithelialization (days) |
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Notes | We tried to contact authors to obtain data on time to re‐epithelialization, given that the study did not provide enough information on this matter, but It was not possible to obtain data that could be used for our review. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "Forty patients with second‐degree burns were treated with amniotic membranes and rifamycin. They were randomly assigned to two treatment groups " (Page 73 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 | No blinding described (therefore, probably open). |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Insufficient information provided. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Did not report number of withdrawals. Comment: denominator values suggested complete follow‐ up. |
Selective reporting (reporting bias) | High risk | No protocol provided, and none of the outcomes reported were nominated in the methods section of this paper. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias existed. |