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OpenTrials
Completed

NCT Number: NCT01201525

Pulsed Dye Laser Treatment of Recent Surgical Scars

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.

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Key information

Conditions

Surgical Scars

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulsed dye laser treatment

Procedure

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

Control

Procedure

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

Primary outcomes

  1. Physician global assessment for the treated and control region (PhGA)

    Time frame: Before start of the study, 1 and 6 months after treatment

  2. Patient global assessment for the treated and control region (PGA)

    Time frame: Before start of the study, 1 and 6 months after treatment

Secondary outcomes

  1. Assessment of scar color by colorimetry

    Time frame: Before start of the study, 1 and 6 months after treatment.

  2. Assessment of scar tickness by ultrasound measurements

    Time frame: Before start of the study, 1 and 6 months after treatment.

  3. Assessment of viscoelasticity by Cutometer measurements

    Time frame: Before start of the study, 1 and 6 months after treatment.

  4. Clinical scar assessment by the Vancouver Scar scale and POSAS scale.

    Time frame: Before the start of the PDL treatment, and 1 and 6 months after the last treatment.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 14, 2010
Registry last updated
Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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