Hypertrophic Scar
Conditions
Brief summary
A prospective, double blind, randomized controlled human clinical trial will be conducted by enrolling patients referred for laser treatment from the USAISR burn clinic. Laser candidates will be asked to participate who have an area of extremity or truncal scar measuring approximately 6cmX6cm total, in one contiguous region. The study sites, will consist of four equally sized treatment areas (3cm x 3cm), will be randomized to be treated with PDL, CO2, a combination of CO2+PDL, and an untreated control for 6 treatments. The areas will be photographed prior to each treatment and at the final visit 4-6 months after the last treatment. Color, pliability and thickness will be measured using a colorimeter, cutometer and high frequency ultrasound respectively at each appointment. Additionally, the Patient Observer Scar Assessment Scale (POSAS) will be used to score the quality of the scar, using two trained, blinded observers. The patients will also be asked on a voluntary basis for a pre-trial and post-trial 3mm punch biopsy to evaluate for the presence of histological changes.
Interventions
PROCEDURETreatment with Pulse Dye Laser
Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.
PROCEDURETreatment with CO2 Laser
CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
PROCEDURETreatment with combination of pulse dye laser and CO2 laser.
Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
OTHERControl
One area will be randomized to receive no laser treatment.
Sponsors
United States Army Institute of Surgical Research
The Metis Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Must have at least four areas of burn scar located on the trunk or extremities measuring 3cm x 3cm and not previously treated with laser. 2. Timing: There has been a minimum of 1 month after burn closure 3. The subject is at least 18 years of age and not older than 65. 4. Able and willing to provide verbal and written consent.
Exclusion criteria
1. Active infection in experimental area 2. Use of isotretinoin (Accutane) in last six months 3. Life or limb-threatening injury/disease 4. Prior history of non-compliance with medical regimes 5. Active drug use/abuse 6. Active psychiatric illness except depression (unless being treated for suicidal intentions) 7. Pregnancy 8. Active cancer, or new diagnosis of cancer within the past 5 years, with the exception of basal cell carcinoma, melanoma and squamous cell carcinoma, as long as the subject is disease free at the time of enrollment. 9. Prior PDL or other laser treatment of the study area. 10. Patient unable to tolerate laser procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of laser treatments | 4-6 weeks post treatment | Using the Patient and Observer Scar Assessment Scale (POSAS), evaluate the effectiveness of Pulse Dye Laser (PDL) and Carbon Dioxide (CO2) laser treatment on symptoms related to Hypertrophic Burn Scar (HBS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of symptoms | 4-6 weeks post treatment | To longitudinally compare the change in symptoms by treatment modality between treatment sessions by assessment with the Patient and Observer Scar Assessment Scale (POSAS) measured for each patient and two observers (to increase score reliability) at each follow-up visit. |
Countries
United States
Outcome results
None listed