Surgical Care And Recovery With Laser Evaluation Trial (SCARLET) (SCARLET)

January 14, 2026 updated by: AdventHealth
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cosmetic Group (Laser/BBL Therapy)

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

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.
No Intervention: Non-Cosmetic Group (Standard Postoperative Care)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SCAR-Q Total Score from Baseline to 6 Months Post-Surgery
Time Frame: Baseline (Preoperative) to 6 months post-surgery (±1 month)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in POSAS (Patient and Observer Scar Assessment Scale) Score from Baseline to 6 Months Post-Surgery
Time Frame: Baseline (Preoperative) to 6 months post-surgery (±1 month)

The POSAS is a hybrid assessment tool composed of patient and observer subscales evaluating scar pigmentation, thickness, surface relief, pliability, pain, and itch.

Lower scores indicate scars more similar to normal skin. Both patient and observer scores will be collected at each postoperative timepoint and compared longitudinally between intervention and control groups.
Baseline (Preoperative) to 6 months post-surgery (±1 month)
Surgical Scar Revision Rate
Time Frame: Baseline (Surgery Day) to 12 months post-surgery

The proportion of participants requiring surgical scar revision within 12 months postoperatively will be compared between the laser/BBL and standard care groups.

Scar revision is defined as any re-excision, laser resurfacing, or procedural intervention performed specifically to improve the cosmetic or structural quality of a prior surgical scar.
Baseline (Surgery Day) to 12 months post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Photographic Evaluation of Scar Appearance
Time Frame: 4 weeks, 8 weeks, 14 weeks, and 6 months post-surgery.
Standardized photographs of surgical sites will be collected at each follow-up visit under controlled lighting and positioning. Blinded evaluators will assess photographs using visual analog scales for pigmentation, surface texture, and overall aesthetic improvement.
4 weeks, 8 weeks, 14 weeks, and 6 months post-surgery.
Patient Global Satisfaction Rating
Time Frame: 6 months post-surgery.
Participants will rate their overall satisfaction with scar appearance and comfort on a Likert scale from "Very Dissatisfied" to "Very Satisfied."
6 months post-surgery.
Incidence of Adverse Events Related to Scar Management
Time Frame: From first laser/BBL treatment through 6-month follow-up.
Adverse events such as erythema, hyperpigmentation, infection, or delayed wound healing will be monitored throughout the study and classified by severity and relationship to the intervention.
From first laser/BBL treatment through 6-month follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 22, 2026

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2379205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will not be sharing information from this study, but will be publishing information in scientific journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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