Homann 2007.
Methods | Country where data collected: Germany RCT with intra‐individual design Unit of randomisation: burn Unit of analysis: burn Duration: 21 days |
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Participants | Inclusion criteria: 2 partial‐thickness burn wounds of comparable size, location and prior treatment, ≤ 3 days from injury; TBSA ≤ 50%; wound area between 36 cm2 ‐300 cm2; upper body injuries needed to both occur on wither ventral or dorsal side Exclusion criteria: infected wounds at study onset, wounds in the axillary or inguinal region, deep body folds or a distinctive adipose tissue region Participants: 43 participants with 2 comparable burns Mean age (years): NR Male participants: NR Burn type: NR Burn degree: partial‐thickness Burn size (%TBSA): 11.1 ± 7.7 (79.2 cm2 vs 77.3 cm2) Burn location: NR |
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Interventions | Intervention arm 1: polyvinylpyrrolidone iodine liposome hydrogel (Repithel) (3% PVP‐iodine, 3% phospholipin 90 H liposome). Applied once daily as 2 mm layer covered with paraffin gauze dressing. N = 43 Intervention arm 2: SSD (10 mg/g). Applied once daily as 2 mm layer covered with paraffin gauze dressing. N = 43 Cointerventions: no additional topical treatments |
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Outcomes | Primary outcome: wound healing Primary outcome: infection Secondary outcome: adverse events |
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Notes | Funding: Mundipharma GmbH (manufacturer) This was a "split‐body" or "intra‐individual" design where a person with two wounds had one wound randomised to each treatment. It was not clear whether the analysis took account of this. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “The randomization list was prepared by the statistics department from Mundipharma GmbH, using the EDP program Rancode 3.6.” Comment: computer‐generated randomisation list is classed as low in terms of risk‐of‐bias. |
Allocation concealment (selection bias) | Unclear risk | Quote: “After written informed consent was obtained, patients were enrolled and the 2 burn wounds to be assessed were randomized to treatment with the liposome PVP‐I hydrogel Repithel or the silver‐sulfadiazine cream Flammazine.” Comment: no explicit mention of allocation concealment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: “A limitation to this study is the fact that, due to the characteristic coloring of PVP‐I, this was not a blinded study." Comment: unblinded study |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Quote: “Forty‐three patients comprised the full analysis set (intent‐to‐treat) and 39 patients completed the study per protocol. Protocol violations were wounds older than 3 days in 2 patients and lack of comparability of wounds or a full‐thickness (degree IIb/III) burn wound in 1 patient each.” Comment: no unexplained loss to follow‐up |
Selective reporting (reporting bias) | Unclear risk | Quote: “The clinical assessment of study wounds included inflammation (secretion, reddening, coating) and healing tendency (very good, good, moderate, none).” Comment: some uncertainty about the above statement – the word “included” implies there may possibly have been more outcomes assessed. |
Other bias | Unclear risk | Comment: it was unclear whether the analysis took account of the intra‐individual design |