Surgical Scars Clinical Trial
Official title:
Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial
| Verified date | August 2011 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser
treatments.
Study design: Prospective single blinded within patient controlled randomised trial. Recent
surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be
treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will
serve as a within patient control. 1 and 6 months after the intervention both parts of the
scar will be evaluated.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | August 2011 |
| Est. primary completion date | August 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with planned surgical intervention leaving a scar from at least 5 cm in an area prone to hypertrophic scarring : neck, shoulders, chest, mandibular angle and extremities - Age at least 18 years old. - Patient able and willing to give written informed consent Exclusion Criteria: - Patients with planned surgical intervention on hands, feet and genital area - Patients with a history of photodermatoses - Patients with a history of keloids - Patients with a history of adverse outcomes related to PDL |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | University Hospital Ghent | Ghent |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Physician global assessment for the treated and control region (PhGA) | Before start of the study, 1 and 6 months after treatment | No | |
| Primary | Patient global assessment for the treated and control region (PGA) | Before start of the study, 1 and 6 months after treatment | No | |
| Secondary | Assessment of scar color by colorimetry | Before start of the study, 1 and 6 months after treatment. | No | |
| Secondary | Assessment of scar tickness by ultrasound measurements | Before start of the study, 1 and 6 months after treatment. | No | |
| Secondary | Assessment of viscoelasticity by Cutometer measurements | Before start of the study, 1 and 6 months after treatment. | No | |
| Secondary | Clinical scar assessment by the Vancouver Scar scale and POSAS scale. | Before the start of the PDL treatment, and 1 and 6 months after the last treatment. | No |