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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 20, 2014