NCT07359352

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Apr 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Oct 2027

First Submitted

Initial submission to the registry

January 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 14, 2026

Last Update Submit

January 14, 2026

Conditions

Post-surgical ScarsHypertrophic ScarsScar Appearance DissatisfactionAesthetic Surgical OutcomesWound Healing After Body-contouring Surgery

Keywords

Surgical scarPostoperative scarHypertrophic scarBody-contouring surgeryAbdominoplasty scarBrachioplasty scarThighplasty scarScar revisionLaser-assisted scar remodeling

Outcome Measures

Primary Outcomes (1)

  • Change in SCAR-Q Total Score from Baseline to 6 Months Post-Surgery

    The SCAR-Q is a validated, patient-reported outcome instrument designed to assess appearance, symptoms (such as pain, itchiness, and tightness), and psychosocial impact of scarring. Scores are transformed on a 0-100 scale, with higher scores indicating better scar-related quality of life and aesthetic satisfaction. The change in total and domain-specific SCAR-Q scores from baseline to six months postoperatively will be compared between participants receiving ProFractional laser/BBL therapy and those receiving standard postoperative care.

    Baseline (Preoperative) to 6 months post-surgery (±1 month)

Secondary Outcomes (2)

  • Change in POSAS (Patient and Observer Scar Assessment Scale) Score from Baseline to 6 Months Post-Surgery

    Baseline (Preoperative) to 6 months post-surgery (±1 month)

  • Surgical Scar Revision Rate

    Baseline (Surgery Day) to 12 months post-surgery

Other Outcomes (3)

  • Photographic Evaluation of Scar Appearance

    4 weeks, 8 weeks, 14 weeks, and 6 months post-surgery.

  • Patient Global Satisfaction Rating

    6 months post-surgery.

  • Incidence of Adverse Events Related to Scar Management

    From first laser/BBL treatment through 6-month follow-up.

Study Arms (2)

Cosmetic Group (Laser/BBL Therapy)

EXPERIMENTAL

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.

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

Non-Cosmetic Group (Standard Postoperative Care)

NO INTERVENTION

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.

Interventions

ProFractional Laser Therapy and/or Broadband Light (BBL) TreatmentDEVICE

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.

Cosmetic Group (Laser/BBL Therapy)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 33567135RESULT

  • Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.

    PMID: 24085055RESULT

  • 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: 12534517RESULT

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Bridget Clinical Operations Manager, MS, MPH, CCRC, CCRP, PMP

CONTACT

407-303-5503bridget.miller@adventhealth.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a prospective, two-arm, parallel-group, single-center cohort study comparing postoperative scar outcomes between: Cosmetic Group - receiving three sessions of ProFractional laser and/or Broadband Light (BBL) therapy at approximately 4, 8, and 14 weeks postoperatively, and Non-Cosmetic Group - receiving standard postoperative care only. Both groups complete standardized scar assessments (SCAR-Q, POSAS) and undergo photographic documentation at predefined intervals up to 6 months after surgery.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2026

First Posted

January 22, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

January 22, 2026

Record last verified: 2026-01