An interventional study of Laser treatment in Post Surgical Scars, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-10.
Sponsored by Henry Ford Health System · Not applicable, Interventional, and Treatment
RATIONALE FOR THE PROJECT
Surgical scars are a challenging condition to treat. The aesthetic outcome of surgical scars is of great importance to patients and physicians after reconstructive surgery. The current approaches for the treatment of surgical scars range from non-invasive approaches to aggressive treatments with re-excision or ablative resurfacing lasers. Fractional photothemolysis is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars.
Fractional photothemolysis (Fraxel SR laser, Reliant technologies, Inc) is a new technology whereby only microthermal zones of injury to the skin are created which triggers the wound healing response, leading to skin repair mechanisms to improve the appearance and textural changes associated with surgical scars. Fractionated resurfacing, with its significant proven efficacy in improving textural and pigmenatary abnormalities with a benign side effect profile, represents a promising novel treatment for surgical scars.
Aim:
Comparison of the outcome of the half of the surgical scar treated with Fraxel SR (Reliant Technologies, Inc.) laser versus the outcome of the contralateral half of the surgical scar which will be treated with the V-Beam Pulse Dye Laser
SIGNIFICANCE:
The cosmetic outcome of surgical scars is of paramount importance to surgeons and patients treated with both cosmetic and reconstructive surgery. It is impossible for surgeons to predict the wound healing properties of individual patients and particular anatomic sites and thus, there is little certainty that can be offered to patients about the cosmetic outcome of their surgical scars.
SUBJECTS IN THE PROJECT:
Inclusion Criteria:
For inclusion, the subject must:
Exclusion criteria:
A. Patients who do not meet the criteria above and/or who fail to follow their post-operative instructions or make both of their post-operative clinic appointments.
B. The control for this study will be the side of the scar treated with the V-Beam Pulse Dye Laser
C. We will be speaking to patients at Henry Ford Dermatology regarding participation in our study. We will ensure that all patients understand the voluntary nature of their participation in the study. They will sign informed consent. In addition, we will be asking patients to give us their assessment of which side of their surgical wound had better improvement, the side treated with Fraxel laser versus the side treated with V-Beam Pulse Dye Laser.
PROJECT DESIGN AND PROCOTOL:
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 12 is below the median of 39 across 251 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →Henry Ford Health System is the lead sponsor of 293 studies on the registry; 50 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 23 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Fraxel laser treatment
Procedure: Laser treatment
Pulsed dye laser treatment
Procedure: Laser treatment
Fraxel and pulsed dye laser
Also known as: -Fraxel SR Laser (Reliant Technologies, Inc.), -V-Beam Pulse Dye laser (Candela Corporation)
Overall cosmetic appearance, relative to adjacent skin and side effects.
Time frame: 6 months
skin matches surrounding skin, no scar formation visible, skin pigmentation and/or texture of scarred region is markedly different from surrounding skin).
Time frame: 6 months
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Henry Ford Health System