Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AdventHealth
- 入组人数
- 150
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and providers are aware of treatment allocation; however, photographic scar evaluations are conducted by blinded assessors who do not have access to participant group assignments or treatment histories. This ensures objectivity in evaluating visual scar outcomes.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.