Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)

About this trial

Last updated 4 months ago

Study ID

2379205

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Started 2 months ago

What is this trial about?

The Surgical Care and Recovery with Laser Evaluation Trial (S.C.A.R.L.E.T.) is a prospective, single-center clinical study conducted at AdventHealth Medical Group Plastic and Reconstructive Surgery at Innovation Tower. The study evaluates whether early adjuvant ProFractional laser and/or Broadband Light (BBL) therapy improves the appearance, texture, and patient-reported outcomes of surgical scars following major body-contouring procedures. Participants undergoing qualifying surgeries will be grouped as either cosmetic (receiving three laser/BBL sessions) or non-cosmetic (receiving standard care only). Scar outcomes will be assessed using validated instruments-SCAR-Q and Patient and Observer Scar Assessment Scale (POSAS)-along with standardized photographic analysis at serial follow-ups through six months postoperatively.

What are the participation requirements?

Inclusion Criteria

Adults aged 18 years or older. Scheduled to undergo one or more of the following major body-contouring procedures during the study period: Brachioplasty (arm lift) Chest or breast contouring surgery Abdominoplasty or panniculectomy Buttock lift or lower body lift Thighplasty (thigh lift) Able and willing to provide written informed consent. Able to read and write in English (required for completion of validated questionnaires). Willing and able to comply with scheduled follow-up visits, questionnaires, and study procedures for up to 12 months post-surgery.

Exclusion Criteria

Inability or unwillingness to provide informed consent. Inability to comply with study visits or procedures. Non-English speakers, as the validated SCAR-Q and POSAS instruments are not currently available in equivalent translations. Current use of nicotine or nicotine-containing products, including cigarettes, vaping, chewing tobacco, or nicotine replacement therapy, due to the known adverse effects of nicotine on wound healing and scar formation. Any medical condition, treatment, or circumstance that, in the opinion of the Investigator, may increase participant risk, compromise safety, or interfere with study participation or data integrity. Pregnant or breastfeeding women (laser/BBL therapy contraindicated in pregnancy). History of abnormal scar formation such as keloids or hypertrophic scarring (if deemed clinically significant by the investigator). Recent energy-based treatment (laser, IPL, or BBL) to the surgical site within the previous 3 months.