Abdominoplasty ScarsNCT00735254
Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars
A study testing pulsed dye laser, Affirm Laser and combined PDL and Affirm Lasers in people with Abdominoplasty Scars, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abdominoplasty Scars
- What is being tested?
- pulsed dye laser, Affirm Laser and combined PDL and Affirm Lasers
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinical Foundation
Cleveland, Ohio, 44195
About this study
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.
Read the 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.
- Conditions
- Abdominoplasty Scars
- Being tested
- pulsed dye laser, Affirm Laser, combined PDL and Affirm Lasers, Placebo
- Keywords
- post, surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulsed dye laserDevice
Also called VBEAM
patient will have scar treated with pulsed dye laser
Affirm LaserDevice
Also called non-ablative laser
patient will have scar treated with Affirm laser
combined PDL and Affirm LasersDevice
Also called VBEAM, non-ablative laser
patient will have scar treated with Affirm and pulsed dye lasers
PlaceboOther
patient will receive no treatment
| Study group | Role | What they receive |
|---|---|---|
| Pulsed dye laser | Active comparator | PDL Patient will be have scar treated with pulsed dye laser. Receives: Device: pulsed dye laser |
| Affirm laser | Active comparator | Patient will be have scar treated with Affirm Laser Receives: Device: Affirm Laser |
| combined PDL and Affirm Lasers | Active comparator | Patient will be have scar treated with combined Affirm + PDL Receives: Device: combined PDL and Affirm Lasers |
| Placebo | Placebo comparator | Patient will be have scar treated with Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionJan 2010
Why it stopped: PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Abdominoplasty ScarsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Tung, MD, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735254
- Sponsor's protocol ID
- 08-352
- Status last verified
- Feb 2018
- First submitted
- 13 Aug 2008
- Last updated
- 8 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulsed Dye Laser and Affirm Laser in the Treatment of Abdominoplasty Scars
- ClinicalTrials.gov ID
- NCT00735254
- Acronym / sponsor ID
- 08-352
- Conditions
- Abdominoplasty Scars
- Keywords
- post, surgical
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 8 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pulsed dye laser | Active comparator | Device: pulsed dye laserPDL Patient will be have scar treated with pulsed dye laser. |
| Affirm laser | Active comparator | Device: Affirm LaserPatient will be have scar treated with Affirm Laser |
| combined PDL and Affirm Lasers | Active comparator | Device: combined PDL and Affirm LasersPatient will be have scar treated with combined Affirm + PDL |
| Placebo | Placebo comparator | Other: PlaceboPatient will be have scar treated with Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pulsed dye laserAlso: VBEAMpatient will have scar treated with pulsed dye laser | Device | Pulsed dye laser |
| Affirm LaserAlso: non-ablative laserpatient will have scar treated with Affirm laser | Device | Affirm laser |
| combined PDL and Affirm LasersAlso: VBEAM, non-ablative laserpatient will have scar treated with Affirm and pulsed dye lasers | Device | combined PDL and Affirm Lasers |
| Placebopatient will receive no treatment | Other | Placebo |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Abdominoplasty Scars
Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
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Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)
Post-surgical Scars, Hypertrophic Scars
Recruiting
Silicone Taping for the Improvement of Abdominal Donor Site Scars
Hypertrophic Scar, Scar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Tung, MD study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulsed dye laser, Affirm Laser and combined PDL and Affirm Lasers in people with Abdominoplasty Scars, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of PDL vs Affirm Laser vs Combined Laser Treatments in Appearance of Surgical Scar (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2018.