Carayanni 2011.
| Methods | Country where data collected: Greece Parallel‐group RCT (stratified by burn thickness) Unit of randomisation: participant Unit of analysis: participant Duration: 18 days |
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| Participants | Inclusion criteria: thermal burns with TBSA < 15% and need for hospitalisation but no need of surgical operation Exclusion criteria: cancer or diabetes Participants: 217 randomised (3 excluded for needing surgery) hospital patients Mean age (years): 42.6 vs 42.7 Male participants: 60/104 vs 71/107 Burn type: flame 57 vs 56; scald 50 vs 48 Burn degree: deep partial‐thickness: 50 vs 52; superficial 54 vs 55 (stratified randomisation) Burn size (%TBSA): NR; surface area 10.26 (4.37) vs 9.89 (4.89) (cm2) Burn location: NR |
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| Interventions | Intervention arm 1: moist exposed burn ointment (MEBO) applied twice per day. No dressings were used. N = 104 Intervention arms 2: povidone iodine applied twice per day plus bepanthenol cream applied twice daily after 3rd or 4th day (according to degree of epithelialisation). No dressings were used. N = 107 Cointerventions: burns were lightly debrided by antiseptic in the shower every second day |
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| Outcomes | Primary outcome: infections Secondary outcome: adverse events Secondary outcome: resource use (length of hospital stay) Secondary outcome: cost associated with resource use Secondary outcome: pain (VAS) |
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| Notes | Funding: most resources provided by Regional General Hospital of Athens "Georgios Gennimatas" (Greece) Department of Plastic Surgery, Microsurgery and Burn Center (equipment, stock medicines (except MEBO), and personnel) MEBO provided by MEBO International Group Company (MEBO medicines, China) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Randomly, alteration [sic] was used of permuted 20 sub‐blocks of sizes from 1‐3 for deep partial thickness burns group and 25 sub‐blocs of the same size for the superficial partial burn groups." Comment: does not state how randomisation sequence was derived |
| Allocation concealment (selection bias) | Unclear risk | Quote: "The allocation was carried out by the staff of outpatient reception desk of the Clinic. Patient Envelopes were provided for patients requiring treatment allocation in each group. These were numbered sequentially and a list was provided with the envelopes and completed with the trial number and patient name. The date when the envelope was opened (i.e., the date of randomization) was added." Comment: the envelopes were sequentially numbered but not said to be sealed or opaque, and it's not known what the reception staff knew about the participants |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Blinding was made only for persons evaluating treatment outcomes in order to eliminate classification bias." This was not the case for pain "Blinding the treatments was not possible because Povidone iodine has a characteristic color and odor" Comment: outcome assessors were blinded to treatment allocation except for pain outcomes where participants were the assessors |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "211 (214 randomized) patients, aged between 18‐75 years were prospectively selected. Three patients were excluded because of violation of the inclusion criteria (need of surgical operation). The flow of the participants is described in Figure 1..... We did have loss of contact for the pain measurement (9th day and after) for 3 patients recovered earlier than 8th day (1 for the MEBO group and 2 for the old therapy group). These censored observations were imputed by the Method of Last Observation Carried Forward, with decreased risk of bias because the censoring occurred near the end of the follow‐up period" Comment: Figure one shows all randomised participants included in analysis; the number of participants affected by censoring was low. |
| Selective reporting (reporting bias) | Low risk | Comment: no specific quote but primary outcomes and other outcomes specified and reported fully |
| Other bias | Low risk | Comment: no specific quote but no evidence of other sources of bias and detailed reporting of methods |