Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

This study has been completed.
Sponsor:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00735254
First received: August 13, 2008
Last updated: January 18, 2010
Last verified: January 2010
  Purpose

The purpose of this study is to examine the effect of using a pulsed dye laser (the VBEAM), a non-ablative laser (the Affirm) and a combination of both lasers to improve the appearance of your surgical scar. Both the pulsed dye laser and Affirm laser are approved by the US Food and Drug Administration (FDA) for the treatment of scars. Surgical scars are a type of scar that can benefit from laser therapy. Redness and the appearance of small blood vessels near the surface of the skin (telangiectasias) develop in such scars as part of the normal healing process and usually spontaneously remit, but often slowly and incompletely. In many cases, lasers can accelerate the clearing of this redness and also improve scar texture.


Condition Intervention Phase
Abdominoplasty Scars
Device: pulsed dye laser (the VBEAM)
Device: Affirm Laser (non-ablative laser )
Device: combined PDL and Affirm Lasers
Device: Placebo
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • The purpose of this study is to determine the efficacy of the 585-nm pulsed dye laser (PDL) and 1440-nm Affirm laser in the treatment of surgical scars starting one week after closure of transverse abdominal incision. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2008
Study Completion Date: January 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
PDL Patient will be have scar treated with pulsed dye laser.
Device: pulsed dye laser (the VBEAM)
Active Comparator: 2
Affirm Laser
Device: Affirm Laser (non-ablative laser )
Active Comparator: 3
combined Affirm + PDL
Device: combined PDL and Affirm Lasers
Placebo Comparator: 4
Placebo
Device: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 years and older
  • No significant medical illness
  • Surgical procedure that involves closure of the transverse abdominal incision performed in the department of dermatology and plastic surgery at the Cleveland Clinic main campus.
  • Subjects with the willingness and ability to understand and provide informed consent

Exclusion Criteria:

  • Under 18 years of age
  • Pregnancy or Lactation
  • Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months
  • Subjects with liver/kidney disease, diabetes mellitus, hypertension, connective tissue disease or who are immunocompromised
  • Subjects with a known susceptibility to keloid formation or hypertrophic scarring
  • Subjects who are unable to understand the protocol or to give informed consent
  • Subjects with mental illness
  • Subjects with obvious non-healing wound
  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: NCT00735254

Locations
United States, Ohio
Cleveland Clinical Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Edward Galiczynski, DO, CCF
ClinicalTrials.gov Identifier: NCT00735254     History of Changes
Other Study ID Numbers: 08-352
Study First Received: August 13, 2008
Last Updated: January 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
post
surgical

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014