Photobiomodulation Therapy for Scar Quality After Facial Wound Closure (PBMT-SCAR)

Effect of Photobiomodulation Therapy (PBMT) on Scar Quality Following Traumatic Facial Wound Closure: A Prospective Pilot Randomized Controlled Trial

This study is a prospective pilot randomized controlled trial designed to evaluate the effect of photobiomodulation therapy (PBMT) on scar quality following traumatic facial wound closure. Traumatic facial wounds often result in aesthetically and functionally significant scars, which may negatively affect patients' quality of life. PBMT has been proposed as a non-invasive adjunctive therapy that may enhance tissue repair, reduce inflammation, and improve scar outcomes.

In this study, patients with traumatic facial wounds undergoing primary closure will be randomly assigned to receive either PBMT or sham treatment following suture removal. Scar quality will be assessed using validated clinical scales over a defined follow-up period. The findings of this study aim to provide clinical evidence regarding the effectiveness of PBMT in improving scar appearance and overall healing outcomes.

Study Overview

• Status: Active, not recruiting
• Conditions: Traumatic Facial Wounds
• Intervention / Treatment: Device: Sham Photobiomodulation Therapy; Device: Photobiomodulation Therapy (PBMT)

Detailed Description

This prospective pilot randomized controlled clinical trial aims to investigate the effect of photobiomodulation therapy (PBMT) on scar quality following traumatic facial wound closure. Traumatic facial wounds represent a common clinical challenge in oral and maxillofacial surgery, often leading to scar formation with aesthetic and psychological consequences. Despite advances in wound management, optimizing scar quality remains a significant concern.

Photobiomodulation therapy (PBMT) has gained increasing attention due to its potential to promote tissue regeneration, enhance collagen organization, modulate inflammatory responses, and accelerate the healing process. In this study, eligible patients presenting with traumatic facial wounds requiring primary closure will be included. All wounds will be managed using standardized surgical protocols, including layered suturing techniques.

Following suture removal, participants will be randomly allocated into two groups: an intervention group receiving PBMT and a control group receiving sham treatment. PBMT will be applied using a diode laser with predefined parameters, including wavelength, power output, irradiation time, and energy density, ensuring consistency across all treatment sessions. The therapy will be administered over multiple sessions according to a standardized treatment protocol.

Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), a validated tool that assesses multiple scar characteristics from both clinician and patient perspectives. Assessments will be performed at predefined follow-up intervals to monitor scar maturation and overall outcomes.

The primary outcome of this study is the improvement in scar quality as measured by POSAS scores. This study is designed as a pilot trial to generate preliminary data that may support the development of larger randomized controlled trials in the future. The results are expected to contribute to the growing body of evidence regarding the clinical applications of PBMT in soft tissue healing and scar management.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • An Najaf
    • Kufa, An Najaf, Iraq, 54001
      • Department of Oral and Maxillofacial Surgery, College of Dentistry, The Islamic University, Najaf, Iraq

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients presenting with traumatic facial wounds requiring primary closure with sutures.
• Superficial to partial-thickness wounds located in the facial region (including infraorbital/periorbital, cheek, chin, forehead, or perioral areas).
• Wound length ranging from 3.5 to 10 cm.
• Patients willing to participate and comply with all treatment sessions and follow-up visits.
• Written informed consent obtained from adult participants or from parents/legal guardians for participants under 18 years of age.

Exclusion Criteria:

• Patients with uncontrolled systemic diseases that may impair wound healing (e.g., uncontrolled diabetes, immunocompromised conditions).
• Patients receiving medications known to affect wound healing (e.g., corticosteroids, immunosuppressive drugs).
• Presence of infected wounds at baseline.
• Patients with a history of keloid or hypertrophic scar formation.
• Pregnant or lactating women.
• Patients who are unable or unwilling to comply with the study protocol or follow-up schedule.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Photobiomodulation Therapy (PBMT); Participants in this group will receive photobiomodulation therapy (PBMT) following suture removal. The treatment will be applied using a diode laser with standardized parameters including wavelength, power output, and energy density. PBMT will be administered over multiple sessions according to a predefined protocol to enhance scar quality and tissue healing.	Device: Photobiomodulation Therapy (PBMT); Photobiomodulation therapy (PBMT) will be administered using a 940 nm diode laser (EPIC X, Biolase Inc., Irvine, CA, USA). The laser will operate in continuous wave (CW) mode with a power output of 2 W. The beam diameter will be approximately 3 cm, corresponding to a spot size of about 7.07 cm and an irradiance of approximately 0.3 W/cm². Each irradiation point will be exposed for 20 seconds, delivering an energy density of approximately 5.6 J/cm. PBMT sessions will be performed three times per week for a total of 10 sessions. Laser irradiation will be delivered using a specialized handpiece in a defocused, non-contact mode to ensure uniform energy distribution across the treatment area.; Other Names: Low-Level Laser Therapy (LLLT)
Sham Comparator: Sham Laser (Control); Participants in this group will receive a sham laser procedure following suture removal. The procedure will mimic the PBMT application in appearance and duration, but without delivering active laser energy. This approach is used to maintain participant blinding and serve as a control for comparison.	Device: Sham Photobiomodulation Therapy; A sham photobiomodulation therapy procedure will be performed using the same 940 nm diode laser device (EPIC X, Biolase Inc., Irvine, CA, USA) without emitting active laser energy. The laser handpiece will be applied in a defocused, non-contact manner over the wound area following suture removal, with the same application time (20 seconds per point) and session frequency (three times per week for a total of 10 sessions) as the active treatment group. This approach is used to maintain participant blinding while ensuring no therapeutic laser energy is delivered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scar Quality Assessed by POSAS	Scar quality will be evaluated using the Patient and Observer Scar Assessment Scale (POSAS), a validated scale that includes both observer-rated and patient-reported components. The POSAS consists of two subscales: Observer Scale (6 items: vascularity, pigmentation, thickness, relief, pliability, and surface area); Patient Scale (6 items: pain, pruritus, color, stiffness, thickness, and irregularity) Each item is scored on a 10-point scale ranging from 1 (normal skin) to 10 (worst imaginable scar), with a total score calculated by summing individual item scores. The total POSAS score ranges from 6 to 60 for each subscale, where lower scores indicate better scar quality and outcomes. Time Frame: 3 months and 12 months after completion of treatment.	3 months and 12 months after completion of treatment

Collaborators and Investigators

• Sponsor: Hani M. Al-Kufi

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Estimated): October 7, 2026
• Study Completion (Estimated): October 20, 2026

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Scar quality; Photobiomodulation therapy (PBMT); Traumatic facial wounds; Patient and Observer Scar Assessment Scale (POSAS)
• Additional Relevant MeSH Terms: Therapeutics; Laser Therapy; Phototherapy; Low-Level Light Therapy
• Other Study ID Numbers: PBMT-RCT-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No