Effect of Photobiomodulation Therapy (PBMT) on Scar Quality Following Traumatic Facial Wound Closure: A Prospective Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Scar Quality Assessed by POSAS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to group allocation through the use of a sham laser procedure identical in appearance to the active PBMT intervention. The outcomes assessor will also be blinded to treatment allocation to minimize assessment bias. The care provider administering the intervention cannot be blinded due to the nature of the procedure.
入排标准
- 年龄范围
- 13 Years 至 47 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Sham Photobiomodulation Therapy (Device)
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.
干预措施: Photobiomodulation Therapy (PBMT) (Device)
结局指标
主要结局
Scar Quality Assessed by POSAS
时间窗: 3 months and 12 months after completion of treatment
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.
次要结局
未报告次要终点
研究者
Hani M. Al-Kufi
Assistant Lecturer, College of Dentistry, Islamic University
Islamic University of Najaf