Pulsed Dye Laser Treatment of Recent Surgical Scars
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedAugust 10, 2011
August 1, 2011
1.7 years
December 2, 2009
August 9, 2011
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
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.
Study Arms (2)
Surgical scar - part 1
EXPERIMENTALSurgical scar - part 1
Surgical scar - part 2
PLACEBO COMPARATORSurgical scar - part 2
Interventions
Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.
Part 2 of the surgical scar will serve as a within patient control.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Ghent
Ghent, 9000, Belgium
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Evelien Verhaeghe, MD
University Hospital, Ghent
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 2, 2009
First Posted
September 14, 2010
Study Start
November 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
August 10, 2011
Record last verified: 2011-08