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

NCT00735254 | Terminated Results

• 1 other identifier: 08-352
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Abdominoplasty Scars

Keywords

post; surgical

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Pulsed dye laser

ACTIVE COMPARATOR

PDL Patient will be have scar treated with pulsed dye laser.

Device: pulsed dye laser

Affirm laser

ACTIVE COMPARATOR

Patient will be have scar treated with Affirm Laser

Device: Affirm Laser

combined PDL and Affirm Lasers

ACTIVE COMPARATOR

Patient will be have scar treated with combined Affirm + PDL

Device: combined PDL and Affirm Lasers

Placebo

PLACEBO COMPARATOR

Patient will be have scar treated with Placebo

Other: Placebo

Interventions

pulsed dye laser DEVICE

patient will have scar treated with pulsed dye laser

Also known as: VBEAM

Pulsed dye laser

Affirm Laser DEVICE

patient will have scar treated with Affirm laser

Also known as: non-ablative laser

Affirm laser

combined PDL and Affirm Lasers DEVICE

patient will have scar treated with Affirm and pulsed dye lasers

Also known as: VBEAM, non-ablative laser

combined PDL and Affirm Lasers

Placebo OTHER

patient will receive no treatment

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinical Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Lasers, Dye

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Limitations and Caveats

protocol was not followed and data was not collected. reported to IRB, closed study. PI left institution

Results Point of Contact

• Title: Edward Galiczynski, MD
• Organization: Arizona Dermatology and Cosmetic

egaliczynski@arizonaderm.com

(602) 277-1449

Study Officials

• Rebecca Tung, MD

  The Cleveland Clinic

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: January 1, 2010
• Last Updated: February 8, 2018
• Results First Posted: February 8, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)