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

This study has been terminated.
(PI decision)
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00735254
First received: August 13, 2008
Last updated: April 18, 2017
Last verified: April 2017
  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
Abdominoplasty Scars Device: pulsed dye laser Device: Affirm Laser Device: combined PDL and Affirm Lasers Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Participant, 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:
  • Efficacy of PDL vs Affirm laser vs combined laser treatments in appearance of surgical scar [ Time Frame: 1 year ]
    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.


Enrollment: 3
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: Pulsed dye laser
PDL Patient will be have scar treated with pulsed dye laser.
Device: pulsed dye laser
patient will have scar treated with pulsed dye laser
Other Name: VBEAM
Active Comparator: Affirm laser
Patient will be have scar treated with Affirm Laser
Device: Affirm Laser
patient will have scar treated with Affirm laser
Other Name: non-ablative laser
Active Comparator: combined PDL and Affirm Lasers
Patient will be have scar treated with combined Affirm + PDL
Device: combined PDL and Affirm Lasers
patient will have scar treated with Affirm and pulsed dye lasers
Other Name: VBEAM, non-ablative laser
Placebo Comparator: Placebo
Patient will be have scar treated with Placebo
Other: Placebo
patient will receive no treatment

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes 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
Investigators
Study Director: Rebecca Tung, MD The Cleveland Clinic
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00735254     History of Changes
Other Study ID Numbers: 08-352
Study First Received: August 13, 2008
Last Updated: April 18, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by The Cleveland Clinic:
post
surgical

ClinicalTrials.gov processed this record on June 23, 2017