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. 2017 Jul 12;2017(7):CD011821. doi: 10.1002/14651858.CD011821.pub2

Homann 2007.

Methods Country where data collected: Germany
RCT with intra‐individual design
Unit of randomisation: burn
Unit of analysis: burn
Duration: 21 days
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
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
Outcomes Primary outcome: wound healing
Primary outcome: infection
Secondary outcome: adverse events
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.
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