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. 2022 Sep 26;2022(9):CD011642. doi: 10.1002/14651858.CD011642.pub2

Alsharnoubi 2018.

Study characteristics
Methods Study design: randomised controlled study (single‐blinded, intra‐individual, split‐scar) conducted in Egypt. Scar segment as the unit of randomisation.
Duration of the study: not reported
Follow‐up time: 12 weeks (intermediate‐term follow‐up)
Protocol was published before recruitment of participants: the study was conducted after the approval of the Laser Institute’s Research Ethical Committee.
Details of trial registration: not reported
Funding sources: none declared
Participants Number of participants assigned: 15 participants (with a total of 30 scar segments treated)
Group 1 (He‐Ne laser plus decamethyltetrasiloxane, polydimethylsiloxan and cyclopentasiloxane cream): 15 scar segments
Group 2 (decamethyltetrasiloxane, polydimethylsiloxan and cyclopentasiloxane cream): 15 scar segments
Loss: not described
Number of participants assessed: 15 participants (with a total of 30 segment scars assessed)
Group 1: 15 scar segments
Group 2: 15 scar segments
Inclusion criteria:
  • children of both sexes, with hypertrophic burn scars.


Exclusion criteria:
  • people with associated disorders, pregnancy, immunodeficiency, HIV, AIDS, or diabetes;

  • people who had skin abnormalities, such as active skin disease within the treatment areas (i.e. psoriasis, cancer, or autoimmune disease);

  • people with evidence of bleeding disorder or unstable heart disease, who had a history of photosensitivity, who had dark skin, or scars over growing joints;

  • people with history of the use of any other treatments for the scar in the past 4 weeks prior to the initiation of therapy.


Age (years): 4.73 ± 1.79 (mean /± SD); age range 2 to 10.
Gender:
‐Male: 5 (33.3%)
‐Female: 10 (66.7%)
Scar location: not specified
Consanguinity:
‐Positive: 9 (60%)
‐Negative: 6 (40%)
Scars aetiology:
‐Flame burn: 8 (53.3%)
‐Scaled burn: 7 (46.7%)
Skin Type:
‐Type I: 0 (0%)
‐Type II: 1 (6.67%)
‐Type III: 5 (33.3%)
‐Type IV: 9 (60%)
‐Type V: 0 (0%)
Skin thickness (by ultrasonography):
‐At baseline: 0.52 ± 0.17 mm (mean ± SD value of the whole scar)
Skin perfusion (by Laser Doppler perfusion imager ‐ LDPI):
‐At baseline: 1.27 ± 0.54 V (mean ± SD value of the whole scar)
Vancouver Scar Scale (VSS):
‐At baseline: 9 (value of the whole scar)
High score:
‐At baseline: 2 (value of the whole scar)
Pigmentation score:
‐At baseline: 2 (value of the whole scar)
Vascularity score:
‐At baseline: 2 (value of the whole scar)
Interventions The hypertrophic scars were divided into 2 halves; 1 half, received He‐Ne laser scanning technique plus topical treatment. The other half, the controlled area, received only Scaro cream.
 
Group 1: a laser device "bravo terza serie HE NE laser (ASA s.r.i)" with a wave length 632.8‐nm (head source with aimed beam) was used perpendicularly to half of hypertrophic scar, during 25 min in each application, with a power density of 119 mW/ cm2 and energy density of 16 J/cm2,using the scanning technique. The distance between the laser probe and the burn was 70 cm length. The treatment interval was twice per week, for 12 weeks. In addition, participants received topical treatment (with Scaro cream Scaro cream ‐ company: Macro; active ingredients: decamethyltetrasiloxane plus polydimethylsiloxane plus cyclopentasiloxane).
Group 2: half of hypertrophic scar received only topical treatment (with Scaro cream Scaro cream ‐ company: Macro; active ingredients: decamethyltetrasiloxane plus polydimethylsiloxane plus cyclopentasiloxane).
Outcomes Primary outcomes:
Vancouver Scar Scale (VSS):
Graded by a blinded observer to evaluate the skin thickness, pigmentation, and vascularity, before the treatment (pre‐test), and 3 months after (post‐test).
Secondary Outcomes:
Change in scar thickness: an ultrasound imaging system (LOGIQ P6 GE healthcare, Japan) was used to measure the skin thickness before the treatment (pre‐test), and 3 months after (post‐test).
Change in scar perfusion (erythema): skin perfusion was also evaluated before the treatment (pre‐test), and 3 months after (post‐test). A Laser Doppler perfusion imager (LDPI): A PIM II laser Doppler perfusion imager used (Lisca AB, Linköping, Sweden) was used.
Notes Descriptive statistics and T test were conducted for comparison of the mean age between both groups. T test was conducted for comparison of treatment mean values of scar thickness, and perfusion between both groups. Paired T test was conducted for comparison between treatment mean values of scar thickness, and perfusion before, and after treatment in each group, as well as areas in‐between the study, and control areas in each group. Mann–Whitney U test was conducted for comparison of VSS between both groups. Wilcoxon signed ranks test was conducted for comparison of VSS between treatment before and after in each group. The level of significance for all statistical tests was set at P < 0.05. All statistical measures were performed through the statistical package for social studies (SPSS) version 19 for windows.
The authors declare that they have 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 Participants and health professionals performing the treatment were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Each scar was evaluated by a blinded evaluator before the treatment (pre‐test), and 3 months after (post‐test)."
Incomplete outcome data (attrition bias)
All outcomes Unclear risk The results are presented and the number of participants included in each analysis is not provided. It was not clear if there were losses during the study.
Selective reporting (reporting bias) High risk No trial protocol is available. There are no data about the treated and control areas before the study, only values for the whole scar (before the study) and values for treated and control areas at the end of the study, regarding to the parameters evaluated.
Other bias Low risk No other sources of bias were found.