Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAdventHealth

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Device

    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.

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Cosmetic Group (Laser/BBL Therapy)Experimental treatment 1 intervention
Group B: Non-Cosmetic Group (Standard Postoperative Care)No intervention 0 interventions

Trial outcomes

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.

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

Secondary outcomes

1

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

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.

Time frame
Baseline (Preoperative) to 6 months post-surgery (±1 month)
2

Surgical Scar Revision Rate

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.

Time frame
Baseline (Surgery Day) to 12 months post-surgery

Other outcomes

1

Photographic Evaluation of Scar Appearance

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.

Time frame
4 weeks, 8 weeks, 14 weeks, and 6 months post-surgery.
2

Patient Global Satisfaction Rating

Participants will rate their overall satisfaction with scar appearance and comfort on a Likert scale from "Very Dissatisfied" to "Very Satisfied."

Time frame
6 months post-surgery.
3

Incidence of Adverse Events Related to Scar Management

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.

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

Locations

This trial has no locations.

Sponsors and contacts

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