Abdominoplasty Scars
Conditions
Keywords
post, surgical
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.
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.
Interventions
DEVICEpulsed dye laser
patient will have scar treated with pulsed dye laser
DEVICEAffirm Laser
patient will have scar treated with Affirm laser
DEVICEcombined PDL and Affirm Lasers
patient will have scar treated with Affirm and pulsed dye lasers
OTHERPlacebo
patient will receive no treatment
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulsed Dye Laser PDL Patient will be have scar treated with pulsed dye laser.
pulsed dye laser: patient will have scar treated with pulsed dye laser | 0 |
| Affirm Laser Patient will be have scar treated with Affirm Laser
Affirm Laser: patient will have scar treated with Affirm laser | 0 |
| Combined PDL and Affirm Lasers Patient will be have scar treated with combined Affirm + PDL
combined PDL and Affirm Lasers: patient will have scar treated with Affirm and pulsed dye lasers | 0 |
| Placebo Patient will be have scar treated with Placebo
Placebo: patient will receive no treatment | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized age >= 18 | — |
| Sex/Gender, Customized male or female | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 1 year
Population: study was not conducted per protocol, data was not collected, study terminated. Reported to IRB and closed study.