Photobiomodulation Therapy for Scar Quality After Facial Wound Closure (NCT07523204) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Photobiomodulation Therapy for Scar Quality After Facial Wound Closure
Iraq36 participantsStarted 2024-10-17
Plain-language summary
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.
Who can participate
Age range
13 Years – 47 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Scar Quality Assessed by POSAS
Timeframe: 3 months and 12 months after completion of treatment