Not Yet RecruitingPhase 4ACTRN12616000343404

Can early intervention with CO2 laser therapy promote scar maturation following a burn injury?


Sponsor

Prof Suzanne Rea

Enrollment

20 participants

Start Date

Apr 4, 2016

Study Type

Interventional

Conditions

Summary

In high income countries, improvements in first aid and acute specialised care have resulted in reduced mortality from major burn injuries (from approximately 25% to less than 9%). Although specialised care has significantly improved outcomes for these patients, the near universal complication of burn-related scarring persists as a constant reminder of limitations of care. For burn survivors, the development of painful, restrictive and disfiguring scarring, known as hypertrophic scarring (HS), has an incidence ranging from 30-70% in reviewed epidemiological data. The treatment of scarring has, thus far, been unable to keep pace with the advancements in resuscitation and other acute therapies. The consequences of scar formation are many and varied, including joint contractures and stiffness, chronic pain, itching, and anhydrosis. Additionally, the emotional repercussions can be significant, with many patients reporting stigmatization and discrimination due to their burn scars. As the mortality of acute burn injury continues to diminish, the burden of scarring may continue to rise. Current treatment options for hypertrophic scarring are not yet sufficient to significantly reduce its associated morbidity. Burn clinicians and researchers are focused on understanding scarring in more depth and discovering potential ways to improve patient outcomes. Within this field of innovation, laser resurfacing techniques are gaining greater interest and are currently being utilised in several centres worldwide for the treatment of HS. The aim of this study is to investigate if the early use of laser treatment helps minimise scar, decreases the time required in pressure garments, improves range of motion and thus results in fewer episodes of expensive reconstructive surgery. A 10,600nm fractional carbon dioxide laser supplied by Lumenis Ltd is the device to be used in this study. This laser has FDA approval for over 100 applications including the management of scars. It has the ability to deliver precise high energy in short-pulses to thickened scars, and has a good record for safety and outcomes. The Burns Service of WA has been using this laser for over 18 months for the management of scars, and the health professionals involved have received the appropriate safety training. Participants will receive 3 laser treatments 4-6 weeks apart. Outcome measures will be conducted before laser treatment, after the last treatment of laser and 3 months post laser treatment.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria5

  • Adults > 18 years of age
  • Two or more non-contiguous discrete burn areas
  • Each burn > 1% TBSA
  • Scars which would ordinarily be managed by pressure garments
  • All patients to be at least 3 months from burn injury

Exclusion Criteria5

  • Pregnant or lactating females,
  • Facial scars
  • Keloid scars
  • Inability to give informed consent
  • Systemic glucocorticoid use

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Interventions

A 10,600nm fractional carbon dioxide laser supplied by Lumenis Ltd is the device to be used in this study. This laser has FDA approval for over 100 applications including the management of scars. It h

A 10,600nm fractional carbon dioxide laser supplied by Lumenis Ltd is the device to be used in this study. This laser has FDA approval for over 100 applications including the management of scars. It has the ability to deliver precise high energy in short-pulses to thickened scars, and has a good record for safety and outcomes. Participants will receive 3 laser treatments 4- 6 weeks apart. The timing of procedures is dependent on patient availability and availability of surgical capacity (ie space on theatre list). Each treatment session lasts between 5 and 15 minutes, depending on the size treated. The patient will receive either a general or local anesthetic prior to the procedure. The choice of anesthetic is at the patient's discretion. The treatments are delivered in a laser safe environment - either in the operating theatre or the laser treatment room on the burns unit. The area to be treated is determined by the surgeon and the patient before the procedure. The laser treatment is delivered by the burn surgeon who is trained in the use of laser therapies and holds a current laser licence. Outcome measures will be conducted before laser treatment, after the third (last) treatment of laser and 3 months after the third laser treatment.


Locations(1)

Fiona Stanley Hospital - Murdoch

WA, Australia

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ACTRN12616000343404


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