Daoud 2019.
Study characteristics | ||
Methods |
Study design: prospective randomised intra‐individual (split‐scar) controlled trial with 3 treatment arms conducted in the USA. Scar segment as the unit of randomisation. Duration of the study: not reported Follow‐up time: 6 months (intermediate‐term follow‐up) Protocol was published before recruitment of participants: the study was board‐approved but there is no mention about protocol publishing. Details of trial registration: not reported Funding sources: this trial received funding from the Lumenis corporation. |
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Participants |
Number of participants assigned: 23 participants (with a total of 69 scar segments enrolled) Group 1 (fractional CO2 laser): 23 segments Group 2 (fractional CO2 laser plus Intense Pulsed Light ‐ IPL) : 23 segments Group 3 (control ‐ no treatment): 23 segments Loss: 4 participants. Number of participants assessed: 19 participants Group 1: 19 segments Group 2: 19 segments Group 3: 19 segments Inclusion criteria:
Exclusion criteria:
Age (years): 18 to 60 Gender: not specified Scar Location: not specified Skin phototypes: I‐IV Duration of scars (months): at least 12 months |
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Interventions | Scars were divided into 3 segments of equal area and randomised into either single laser, multi‐laser, or control (no laser treatment). Analgesia was achieved topically with BLT (20% / 8% / 4%). Group 1: submitted to a total of 4 treatment sessions at 6 to 8‐week interval, with single laser CO2 AFL (Lumenis UltraPulse Encore™, Yokneam, Israel, 15 to 20 mJ, 10% Density, 200 to 300 Hz, 120 μm spot). Group 2: submitted to a total of 4 treatment sessions at 6 to 8‐week interval, with IPL (Lumenis M22 IPL, Yokneam, Israel, 15 mm × 35 mm footprint, settings varied based on scar) immediately followed by CO2 AFL (same parameters of group 1). Group 3: no treatment. |
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Outcomes |
Primary outcomes Manchester Scar Scale (MSS): The MSS considered 5 categories (colour, matte versus shiny, contour, distortion and texture) and was assessed by a blinded observer. Lower scores indicate a better scar character profile. The average decrease in MSS score was reported and means scar severity (improvement). Patient and Observer Scar Assessment Scale (POSAS): The POSAS is a scar assessment scale that combine participant and blinded observer evaluation of 5 components: appearance, pigmentation, hypertrophy, vascularity and roughness (results from 5 to 50; the highest score reflects the worst scar). Secondary Outcomes: Digital Photography assessment: Digital photographs (pre‐ and post‐treatment) were evaluated by blinded observers, in order to identify which one was taken before and after treatment; they also analysed if there was improvement of the scars (appearance). |
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Notes |
Statistical analysis: Data were analysed using a parametric analysis of variance (ANOVA) between the 3 groups (control, CO2 alone, CO2 plus IPL) and the 2 time periods (pre‐treatment and post‐treatment). A 2 x 3 ANOVA with repeated measures was used for statistical comparisons. The trial received funding from the Lumenis corporation. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation was cited but the method was not described. |
Allocation concealment (selection bias) | Unclear risk | Allocation process was not described. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and health professionals performing the treatment were not blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Results were assessed by a blinded observer. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Four lost to follow‐up prior to the third treatment. The reasons were specified (loss of communication). As‐treated analyses were performed. |
Selective reporting (reporting bias) | Unclear risk | No trial protocol is available. All parameters listed in the methods section to assess changes in the scars were described, however, the methods used to assess these parameters were not described. |
Other bias | Low risk | No other sources of bias were found. |