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

Abdominoplasty Scars Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00735254
• Other study ID #: 08-352
• Status: Terminated
• Phase: N/A
• First received: August 13, 2008
• Last updated: February 7, 2018
• Start date: July 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2018
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

In summary, we will perform a total of three laser treatments. A personal interview, clinical examination, and a photograph will be taken at each visit. At the end of the three treatments, a final personal interview, clinical evaluation and photograph will be taken to document the effects of the laser treatments. At the end of the study, the patient will have the option to receive two additional laser treatments four weeks apart, also at no cost, to the entire scar.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2010
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominoplasty Scars

Intervention

Device:
• pulsed dye laser
patient will have scar treated with pulsed dye laser
• Affirm Laser
patient will have scar treated with Affirm laser
• combined PDL and Affirm Lasers
patient will have scar treated with Affirm and pulsed dye lasers

Other:
• Placebo
patient will receive no treatment

Locations

Country	Name	City	State
United States	Cleveland Clinical Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar	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.	1 year