Manuskiatti 2001.

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: 32 weeks (intermediate‐term follow‐up) Protocol was published before recruitment of participants: not reported Details of trial registration: not reported Funding sources: none
Participants	Number of participants assigned: 10 participants (keloidal or hypertrophic median sternotomy scars of 10 participants were divided into 4 segments, with a total of 40 segments evaluated) Segment 1 (585‐nm PDL 3J/cm²): a total of 10 segments treated Segment 2 (585‐nm PDL 5J/cm²): a total of 10 segments treated Segment 3 (585‐nm PDL 7J/cm²): a total of 10 segments treated Segment 4 (no treatment ‐ control segment): a total of 10 segments not treated Loss: none Number of participants assessed: 10 participants (40 segments) Segment 1: a total of 10 segments treated Segment 2: a total of 10 segments treated Segment 3: a total of 10 segments treated Segment 4: a total of 10 segments not treated Inclusion criteria: participants with keloidal or hypertrophic median sternotomy scars, considered by the participant to not be healing as he or she desired; scars should have at least 6 months duration. Exclusion criteria: scars should not have received prior treatment. Age: 59 ± 19 years of age (mean ± SD) Gender: female: 6; 60 (number; %); male: 4; 40 (number; %) Duration of scars: at least 6 months Skin phototypes: Skin type I: 1; 10 (number; %) Skin type II: 5; 50 (number; %) Skin type III: 2; 20 (number; %) Skin type VI: 2; 20 (number; %) Scar Location: median sternotomy scars Scar Length: not specified Scar Cause: post‐surgery
Interventions	Each scar was divided equally into 4 segments with an area of 1 cm untreated between individual treated segments to avoid the effect of overlapping pulses on the adjacent treated area and to have a well‐defined segment for observation of each treatment modality. Three segments of each scar were randomly treated with a 585‐nm PDL (Photogenica V, Cynosure Inc, Bedford, Mass). Laser spots were overlapped by 10%, and the entire lesion of each segment, including a few millimetres surrounding the lateral aspects of the lesion, was irradiated during each session. The location assignment of each of the 4 segments (superior to inferior) was rotated sequentially with each participant to minimise potential effects of scar location. Segment 1: 1 segment of each participant's scar was treated with a 585‐nm PDL using a 450‐msec pulse and 5‐mm spot size at an energy density of 3 J/cm² for 6 treatment sessions at 4‐week intervals. Segment 2: 1 segment of each participant's scar was treated with a 585‐nm PDL using a 450‐msec pulse and 5‐mm spot size at an energy density of 5 J/cm² for 6 treatment sessions at 4‐week intervals. Segment 3: 1 segment of each participant's scar was treated with a 585‐nm PDL using a 450‐msec pulse and 5‐mm spot size at an energy density of 7 J/cm² for 6 treatment sessions at 4‐week intervals. Segment 4: 1 segment of each participant's scar was not treated (control).
Outcomes	Primary outcomes Overall Scar Improvement (Patient Self‐assessment): At the end of the study, participants subjectively evaluated the improvement of their scars' severity compared with a standardised photograph taken before treatment. The results were graded as being completely clear (100% improvement) or placed in a category of 25% increments. Treatment‐related adverse effects: The areas treated with the PDL became purpuric, which lasted from 7 to 10 days. There were erosions secondary to blistering on some areas treated with a fluence of 5 J/cm² and on all areas treated with 7 J/cm² in participants with skin type VI. All erosions healed within 7 days. Neither treatment‐related adverse textural nor pigmentary alterations were observed on conclusion of the study. Secondary Outcomes: Change in scar height: dial calliper (Mitutoyo, Japan) was used to determine the scar height by measuring the maximum vertical elevation of the scar above normal skin. Change in scar erythema: scar erythema was quantified with a hand‐held colorimeter (ChromaMeter CR‐200; Minolta, Ramsey, NJ). A higher erythema value indicates an increased saturation towards redness. The mean of 3 measurements was obtained from each area under study. Change in scar pliability: scar pliability was graded according to a standard scale used to assess functional mobility of the scar related to the contracture and elastic texture of the scar. Change in scar symptoms: all participants (4/4) who had pruritic or irritative sensations reported cessation of the symptoms after one laser session. Change in scar texture: an improvement in scar texture towards that of adjacent normal skin was also observed in all laser‐irradiated segments.
Notes	The authors have indicated no significant interest with commercial supporters and no conflict of interest.
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	Not described.
Blinding of participants and personnel (performance bias) All outcomes	High risk	There is no mention about blinding of participants or health professionals. It is likely that the blinding could have been broken, and the outcomes are likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	There is no mention about the blinding of the evaluators.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants completed the study.
Selective reporting (reporting bias)	Low risk	No trial protocol is available, but all parameters listed in the methods section to assess changes in the scars were described.
Other bias	Low risk	No other sources of bias were found.