Post-surgical ScarsSCARLETNCT07359352
Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)
A study testing ProFractional Laser Therapy and/or Broadband Light (BBL) Treatment in people with Post-surgical Scars and Hypertrophic Scars, run by AdventHealth.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-surgical Scars, Hypertrophic Scars, Scar Appearance Dissatisfaction
- What is being tested?
- ProFractional Laser Therapy and/or Broadband Light (BBL) Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Bridget Clinical Operations Manager, MS, MPH, CCRC, CCRP, PMP contact
About this study
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.
Read the 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.
- Conditions
- Post-surgical Scars, Hypertrophic Scars, Scar Appearance Dissatisfaction, Aesthetic Surgical Outcomes, Wound Healing After Body-contouring Surgery
- Being tested
- ProFractional Laser Therapy and/or Broadband Light (BBL) Treatment
- Keywords
- Surgical scar, Postoperative scar, Hypertrophic scar, Body-contouring surgery, Abdominoplasty scar, Brachioplasty scar, Thighplasty scar, Scar revision, Laser-assisted scar remodeling
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline (Preoperative) to 6 months post-surgery (±1 month)
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.
Measured: Baseline (Surgery Day) to 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-surgical ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07359352
- Sponsor's protocol ID
- 2379205
- Acronym
- SCARLET
- Status last verified
- Jan 2026
- First submitted
- 14 Jan 2026
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will not be sharing information from this study, but will be publishing information in scientific journals.
Publications
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.
PubMed 33567135Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.
PubMed 24085055Tanzi 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.
PubMed 12534517
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Care And Recovery With Laser Evaluation Trial (SCARLET)
- ClinicalTrials.gov ID
- NCT07359352
- Acronym / sponsor ID
- SCARLET / 2379205
- Conditions
- Post-surgical Scars, Hypertrophic Scars, Scar Appearance Dissatisfaction, Aesthetic Surgical Outcomes, Wound Healing After Body-contouring Surgery
- Keywords
- Surgical scar, Postoperative scar, Hypertrophic scar, Body-contouring surgery, Abdominoplasty scar, Brachioplasty scar, Thighplasty scar, Scar revision
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cosmetic Group (Laser/BBL Therapy) | Experimental | Device: ProFractional Laser Therapy and/or Broadband Light (BBL) TreatmentParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProFractional Laser Therapy and/or Broadband Light (BBL) TreatmentProFractional 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. | Device | Cosmetic Group (Laser/BBL Therapy) |
Primary outcome
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.
2 secondary outcomes
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)
Surgical Scar Revision Rate
Time frame: Baseline (Surgery Day) to 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Results publication: PubMed 33567135Chung 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.
- Results publication: PubMed 24085055Cohen JL. Minimizing skin cancer surgical scars using ablative fractional Er:YAG laser treatment. J Drugs Dermatol. 2013 Oct;12(10):1171-3.
- Results publication: PubMed 12534517Tanzi 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.
- Individual participant dataSharing planned: Undecided. We will not be sharing information from this study, but will be publishing information in scientific journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bridget Clinical Operations Manager, MS, MPH, CCRC, CCRP, PMP contact
Questions about this trial
What is this clinical trial studying?
A study testing ProFractional Laser Therapy and/or Broadband Light (BBL) Treatment in people with Post-surgical Scars and Hypertrophic Scars, run by AdventHealth.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bridget Clinical Operations Manager, MS, MPH, CCRC, CCRP, PMP (407-303-5503, bridget.miller@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in SCAR-Q Total Score from Baseline to 6 Months Post-Surgery (time frame: Baseline (Preoperative) to 6 months post-surgery (±1 month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07359352, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.