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临床试验/ACTRN12620001071910
ACTRN12620001071910已完成未知

Evaluation of subjective and objective scar outcomes post treatment of burn scars with fractionated CO2 ablative laser.

Dr Marcus Wagstaff0 个研究点目标入组 13 人开始时间: 2020年10月19日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
13

研究概览

简要总结

Patients who attended Royal Adelaide Hospital Burns Unit for a reconstruction review and went on to undergo CO2 laser to their scars were invited to participate in this study. 13 participants were included, some of which had repeat laser procedure to their scars and still had measurements taken. The outcomes that were rated by the patients themselves showed improvements in the treated scars with scores reaching a similar score to that given to the control scars which were not lasered. As part of the ratings completed by the patients, itch was also rated and also showed a decline after the laser procedures. Ratings completed by the investigator did not show any significant change in scar outcomes. The instruments used to measure depth (ultrasound), colour, water loss, and elasticity did not show any significant difference between lasered and non-lasered scars. There was a trend for some improvement of lasered scars up until 6 months affter the procedure but then a return to baseline at 12months. We were unable to establish a protocol for laser following a table outlining laser settings according to scar thickness due to other clinical factors impacting upon the surgeons choice of settings.

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
All

入选标准

  • Patients who consent to laser treatment
  • 18 years – 80 years
  • Burns scars with functional (e.g. itch, pain, contracture, limiting range of motion) and/or cosmetic impairment (e.g. pigmentation)
  • Patients whose scars have been assessed by a clinician as appropriate for laser management to improve scar outcome.

排除标准

  • Inability to provide consent – psychiatric or medical comorbidity
  • Active infections
  • Previous radiation treatment to the laser treatment area (i.e. Radiotherapy)
  • Pregnancy or lactation
  • Patients who are taking part in any other trial that may affect the outcome
  • Complex locations e.g. eyelids; ears; lips; genitals (difficulties with scar Ax)
  • Lumenis® CO2 laser is contraindicated where a patient has taken Accutane (Isotretinoin) within the past 6-12 months,
  • Has a history of keloid formation and demonstrate excessive or unusually prolonged erythema.

研究者

发起方
Dr Marcus Wagstaff

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