Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 t

Первичные конечные точки

• Change in SCAR-Q Total Score from Baseline to 6 Months Post-Surgery [Срок оценки: Baseline (Preoperative) to 6 months post-surgery (±1 month)]

Вторичные конечные точки (2)

• Change in POSAS (Patient and Observer Scar Assessment Scale) Score from Baseline to 6 Months Post-Surgery [Срок оценки: Baseline (Preoperative) to 6 months post-surgery (±1 month)]
• Surgical Scar Revision Rate [Срок оценки: Baseline (Surgery Day) to 12 months post-surgery]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Chung JH, Kim DS, Cheon JH, Yoon JM, Baek SK, Jung KY, Yoon ES, Park SH. Current Protocol for Aesthetic Scar Management in Thyroid Surgery. Laryngoscope. 2021 Jul;131(7):E2188-E2195. doi: 10.1002/lary.29441. Epub 2021 Feb 10. PMID 33567135
• Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3. PMID 24085055
• Tanzi EL, Alster TS. Single-pass carbon dioxide versus multiple-pass Er:YAG laser skin resurfacing: a comparison of postoperative wound healing and side-effect rates. Dermatol Surg. 2003 Jan;29(1):80-4. doi: 10.1046/j.1524-4725.2003.29012.x. PMID 12534517

Идентификаторы

NCT: NCT07359352 · 2379205

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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