Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)

AdventHealth

Status: Begins enrollment in 1 month

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

Treatments: Device: ProFractional Laser Therapy and/or Broadband Light (BBL) Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07359352

2379205

Details and patient eligibility

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Cosmetic Group (Laser/BBL Therapy)

Experimental group

Description:

Participants in this group will receive three sessions of ProFractional laser and/or Broadband Light (BBL) therapy following their qualifying body-contouring surgical procedure. Treatments will begin approximately 4 weeks postoperatively, with subsequent sessions at 8 weeks and 14 weeks (±2 weeks). Laser parameters will be determined by the treating provider based on clinical assessment and Fitzpatrick Skin Type. Assessments will include standardized scar photographs, SCAR-Q, and POSAS questionnaires at each visit and at 6 months postoperatively. The objective is to determine whether early adjuvant energy-based therapy improves scar quality, appearance, and patient-reported satisfaction compared to standard care.

Treatment:

Device: ProFractional Laser Therapy and/or Broadband Light (BBL) Treatment

Non-Cosmetic Group (Standard Postoperative Care)

No Intervention group

Description:

Participants in this group will undergo standard postoperative wound management without laser or BBL therapy. They will complete the same follow-up visits and outcome assessments as the cosmetic group-including SCAR-Q and POSAS questionnaires, and standardized photographic documentation-at 4, 8, and 14 weeks, and 6 months postoperatively. This group serves as a comparator to evaluate the natural progression of scar healing and satisfaction under standard care conditions.