Pulsed Dye Laser Treatment of Recent Surgical Scars

Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01201525

Enrollment

Registered

2010-09-14

Start date

2009-11-30

Completion date

2011-08-31

Last updated

2011-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Scars

Brief summary

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.

Interventions

PROCEDUREPulsed dye laser treatment

Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.

PROCEDUREControl

Part 2 of the surgical scar will serve as a within patient control.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Physician global assessment for the treated and control region (PhGA)	Before start of the study, 1 and 6 months after treatment
Patient global assessment for the treated and control region (PGA)	Before start of the study, 1 and 6 months after treatment

Secondary

Measure	Time frame
Assessment of scar color by colorimetry	Before start of the study, 1 and 6 months after treatment.
Assessment of scar tickness by ultrasound measurements	Before start of the study, 1 and 6 months after treatment.
Assessment of viscoelasticity by Cutometer measurements	Before start of the study, 1 and 6 months after treatment.
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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026