Khattab 2019.
Study characteristics | ||
Methods |
Study design: randomised parallel controlled trial conducted in Egypt. Participants as the unit of randomisation. Duration of the study: March 2018 to March 2019 Follow‐up time: 24 weeks (intermediate‐term follow‐up) Protocol was published before recruitment of participants: not reported Details of trial registration: not reported Funding sources: none declared |
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Participants |
Number of participants assigned: 40 participants with a total of 56 keloid scars Group 1 (intralesional Verapamil): total of 20 participants treated (26 keloids treated) Group 2 (PDL plus intralesional Verapamil): total of 20 participants treated (30 keloids treated) Loss: not described Number of participants assessed: 40 (56 scars) Inclusion criteria:
Exclusion criteria:
Age (mean) Group 1: 30.45 Group 2: 32.65 Race: not reported Gender: Group 1: male 11; 55 (number; %); female 09; 45 (number; %) Group 2: male 09; 45 (number; %); female 11; 55 (number; %) Skin phototypes: not reported Duration of scar (months): 6 months to 20 years Scar Location: Group 1: extremity 10; 50; trunk: 2; 10; face: 2; 10. Group 2: extremity 9; 45; trunk: 4; 20; face: 2; 10. Scar Aetiology: Group 1: trauma: 8; 40 (number; %); burn: 6; 30 (number; %); spontaneously: 6; 30 (number; %). Group 2: trauma: 10; 50 (number; %); burn: 6; 20 (number; %); spontaneously: 4; 20 (number; %). Previous Treatment: not reported |
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Interventions |
Group 1: 20 participants were only treated with intralesional verapamil 2.5 mg/mL (verapamil hydrochloride ‐ Verahexal Knoll AG, Ludwigshafen, Germany), every 3 weeks, for a maximum of 8 sessions or until complete flattening of the scar. Group 2: 20 participants treated with PDL (4‐15 J/cm2, 7 mm spot, 1.5 msec pulse duration, 595‐nm wavelength, DCD, 30 msec spray: 20 msec delay) every 6 to 8 weeks, and intralesional verapamil. A minimum of 4 sessions was advised to the participants for the purpose of this study. Laser beams of various shapes were used which included square, hexagonal or line for various shapes and areas of keloids, based on suitability and convenience. The single pass was given to all the participants selected. Post‐procedure cooling was done following the laser treatment. Systemic antibiotic, azithromycin 500 mg once a day for 3 days, and topical antibacterial cream containing fusidic acid for a week were prescribed. |
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Outcomes | At every session, pretreatment photographs were taken under the identical camera and lighting conditions and measurements were recorded for both the groups. Primary outcomes Participants Satisfaction Scale (PSS): Clinical and photographic assessment to evaluate the improvement in overall appearance, dyschromia, the degree of hypertrophy, and texture using a modified Manchester quartile score (MQS)(14). The following 4‐point scale was utilised: 0 ‐ less than 25% improvement; 1‐ 25% to 50% improvement; 2‐ to 50% to 75% improvement; 3 ‐ more than 75% improvement. For each participant, scores in each category were then averaged to assign an overall score. Vancouver scar scale: Assessed scars on 4 domains: vascularity, pigmentation, pliability, and height. The scores range from 0 to 14. The maximum score is 14, indicating the worst result; a score of 0 indicates normal skin. For VSS, keloid height was measured with callipers; pliability was assessed by palpation; vascularity was assessed by visual inspection, and pigmentation was scored after blanching and comparing it with the surrounding skin. |
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Notes |
Statistical analysis:
Data are presented as percentage, mean, and SD. Percentages were compared using the X2‐test, linear correlations, and statistical program at 0.05, 0.01, and 0.001 level of P. The Wilcoxon test was used to test the significant improvement of VSS parameters in each group. The VSS scores were compared between the 2 groups using the Mann‐Whitney U test. A P value < 0.05 was considered to be statistically significant. Statistical analysis was done using SPSS version 19. Financial support and sponsorship: nil. Conflicts of interest: there are no conflicts of interest. |
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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 | Not cited or 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 | Unclear risk | There is no mention about the blinding of the evaluators. |
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) | Low risk | No trial protocol is available, but all parameters listed in the methods section to assess the scar changes were described. |
Other bias | Low risk | No other sources of bias were found. |