NCT07359352

Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: AdventHealth · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Surgical body-contouring procedures often produce long, visible scars that can affect patient satisfaction and quality of life. This study aims to determine whether early initiation of fractional laser or BBL therapy can enhance wound remodeling, reduce scar revision rates, and improve overall aesthetic and psychosocial outcomes compared to standard postoperative care. Eligible adult participants (≥18 years) scheduled for body-contouring procedures-including brachioplasty, chest/breast contouring, abdominoplasty/panniculectomy, buttock/lower-body lift, or thighplasty-will be enrolled. Participants will be assigned to one of two cohorts: Cosmetic Group: Will receive three sessions of laser and/or BBL therapy at approximately 4, 8, and 14 weeks postoperatively, following established safety parameters. Non-Cosmetic Group: Will receive standard postoperative care without adjuvant light-based treatment. Both groups will complete the SCAR-Q and POSAS questionnaires at 4, 8, 14 weeks, and 6 months after surgery. Standardized photographs of the surgical site will be taken at each visit for blinded evaluation of scar color, texture, and overall quality. Fitzpatrick Skin Type will be recorded for subgroup analysis. The primary objective is to determine whether early adjuvant laser/BBL therapy produces statistically significant and clinically meaningful improvements in scar quality-based on SCAR-Q and POSAS scores-compared to standard care. The secondary objective is to assess whether adjuvant treatment reduces the incidence of surgical scar revisions within the first postoperative year. The study will enroll approximately 150 participants and is expected to take up to 24 months for recruitment with a total study duration of 36 months (including analysis). Statistical analyses will include repeated measures ANOVA and Chi-square tests with α = 0.05. Safety assessments will include documentation of adverse events related to both surgery and light-based therapy (e.g., erythema, hyperpigmentation, infection, or delayed wound healing). All laser treatments will be performed by qualified providers in accordance with manufacturer guidelines and institutional protocols. No compensation is provided to participants. Findings are intended for publication in peer-reviewed surgical or aesthetic medicine journals to improve evidence-based postoperative scar management strategies.

Conditions

• Post-surgical Scars
• Hypertrophic Scars
• Scar Appearance Dissatisfaction
• Aesthetic Surgical Outcomes
• Wound Healing After Body-contouring Surgery

Interventions

Type	Name	Description
DEVICE	ProFractional Laser Therapy and/or Broadband Light (BBL) Treatment	ProFractional laser creates microthermal injury zones that stimulate collagen remodeling and accelerate re-epithelialization. Broadband Light (BBL) therapy uses filtered pulsed light to target hemoglobin and melanin, reducing erythema and pigmentation while promoting dermal repair. Each participant in the cosmetic arm will receive up to three sessions spaced 4-6 weeks apart, using device settings individualized by the investigator to the participant's scar characteristics and skin type. All treatments are performed by trained and credentialed clinical staff in accordance with manufacturer safety guidelines and AdventHealth institutional standards.

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-10-01
• First posted: 2026-01-22
• Last updated: 2026-01-22