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Pulsed Dye Laser Treatment of Recent Surgical Scars

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01201525
First received: December 2, 2009
Last updated: August 9, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Surgical Scars
 Procedure: Pulsed dye laser treatment
Procedure: Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Scars
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Physician global assessment for the treated and control region (PhGA) [ Time Frame: Before start of the study, 1 and 6 months after treatment ] [ Designated as safety issue: No ]
  • Patient global assessment for the treated and control region (PGA) [ Time Frame: Before start of the study, 1 and 6 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of scar color by colorimetry [ Time Frame: Before start of the study, 1 and 6 months after treatment. ] [ Designated as safety issue: No ]
  • Assessment of scar tickness by ultrasound measurements [ Time Frame: Before start of the study, 1 and 6 months after treatment. ] [ Designated as safety issue: No ]
  • Assessment of viscoelasticity by Cutometer measurements [ Time Frame: Before start of the study, 1 and 6 months after treatment. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Surgical scar - part 1
Surgical scar - part 1
 Procedure: Pulsed dye laser treatment
Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.
Placebo Comparator: Surgical scar - part 2
Surgical scar - part 2
 Procedure: Control
Part 2 of the surgical scar will serve as a within patient control.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01201525

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Evelien Verhaeghe, MD University Hospital, Ghent
  More Information

Additional Information:
website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Evelien Verhaeghe, MD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT01201525     History of Changes
Other Study ID Numbers: 2009/218
Study First Received: December 2, 2009
Last Updated: August 9, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013