Blue Light for Donor Site Healing in Burn Patients
Recruiting now · Not applicable
Conditions studied: Donor Site Complication, Burn, Photobiomodulation Therapy, Blue Light
In brief
The goal of this clinical trial is to learn whether blue light (BL) photobiomodulation can improve the healing of donor site (DS) wounds in patients with burn injuries who are treated surgically. This study will investigate whether adding BL therapy to the usual treatment can improve healing and patient outcomes in adult patients with intermediate and deep burns. The main questions it aims to answer are: * Does the use of BL therapy combined with standard treatment reduce the healing time of DS compared with standard treatment alone? * Does BL therapy improve wound conditions, reduce pain, and decrease signs of infection during the healing process? * Is BL therapy safe and well tolerated when applied to DS? * Does the treatment improve the long-term quality of the scar after healing? Researchers will compare DS areas treated with standard care alone to DS areas treated with standard care plus BL therapy to see whether BL improves healing outcomes. Each participant will serve as their own comparison: two different DS areas on the same patient will receive the two different treatments. Participants will: * Receive the standard treatment for DS, which includes routine wound care and dressing * Receive BL therapy on one DS area in addition to the standard treatment, while another DS area will receive standard treatment alone * Attend regular clinical evaluations where clinicians will assess wound healing and the condition of the wound bed * Report their pain levels using a simple numeric scale during the healing period * Undergo skin swabs to detect possible signs of infection * Be monitored for any local side effects, such as redness, burning sensation, warmth, itching, or skin irritation related to the light treatment After the DS have completely healed, participants will return for follow-up visits at 1 month and 3 months. During these visits, researchers will evaluate the quality of the scars and monitor for any late side effects.
Key facts
- Study ID
- NCT07453927
- Run by
- AUSL Romagna Rimini
- People needed
- 25
- Starts
- 2025-09-29
- Expected to finish
- 2026-09-28
- Last updated by the study team
- 2026-04-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients with intermediate-deep burns with Total Body Surface Area (TBSA) > 10% requiring surgical treatment with escharectomy, presenting at least two Donor Site.
- Patients over 18 years of age;
- Patients who have signed the informed Consent Form (ICF) and understood the purpose of the study, or, if unable to give consent personally due to their condition, their legal guardian.
You may not qualify if…
- Intermediate-deep burns TBSA < 10% or superficial burns;
- Patients under the age of 18;
- Patients who are participating in other clinical trials with drugs or medical devices;
- Patients with neoplasms or other conditions requiring the use of cytostatic or immunosuppressive drugs;
- Patients with conditions that induce skin photosensitivity;
- Pregnant or breastfeeding women;
- Patients or relatives who are unable to understand the purposes of the trial;
Where it is running
- U.O. Centro Grandi Ustionati - Osp. Maurizio Bufalini — Cesena, Forlì-Cesena, Italy (enrolling)
Full record on ClinicalTrials.gov
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