Blue Light for Donor Site Healing in Burn Patients

ConditionsDonor Site Complication Burn Photobiomodulation Therapy Blue Light

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorAUSL Romagna Rimini

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

Photobiomodulation with blue light
Device
The BL will be applied to the entire DS for 60 seconds, with one session per week, for a total of 3-4 weeks depending on the healing process.

Treatment groups

25 Participants

are divided into 2 treatment groups

Group A: Experimental treatmentExperimental treatment 1 intervention

Group B: Standard TreatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

Donor Site Healing Time

To compare the healing times of skin Donor Site treated with Standard of Care (SoC) in combination with Blue Light therapy compared to those treated with SoC.

Time frame