Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars - Full Text View

Sponsored by:	The Cleveland Clinic
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00735254

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:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars

Resource links provided by NLM:

MedlinePlus related topics: Scars Surgery

U.S. FDA Resources

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
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator PDL Patient will be have scar treated with pulsed dye laser.	Device: pulsed dye laser (the VBEAM)
2: Active Comparator Affirm Laser	Device: Affirm Laser (non-ablative laser )
3: Active Comparator combined Affirm + PDL	Device: combined PDL and Affirm Lasers
4: Placebo Comparator 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735254

Locations

United States, Ohio
Cleveland Clinical Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Edward M Galiczynski, DO 216-445-8454 galicze@ccf.org
Principal Investigator: Edward M Galiczynski, DO
Principal Investigator: Rebecca Tung, MD
Sub-Investigator: Risal Djohan, MD

Sponsors and Collaborators

The Cleveland Clinic

More Information

No publications provided

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

Keywords provided by The Cleveland Clinic:

post
surgical

Study placed in the following topic categories:

Skin Diseases
Cicatrix

Additional relevant MeSH terms:

Skin Diseases
Cicatrix

ClinicalTrials.gov processed this record on September 04, 2009