Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07453927

Blue Light in the Treatment of Donor Site in Burn Patients: a Controlled Clinical Trial

Led by AUSL Romagna Rimini · Updated on 2026-04-06

25

Participants Needed

1

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether blue light (BL) photobiomodulation can improve healing of donor site wounds in adult patients with intermediate or deep burn injuries treated surgically. The study aims to find out if adding BL therapy to standard care reduces healing time, improves wound conditions, reduces pain and infection signs, is safe, and enhances long-term scar quality. Burn injuries often require skin grafting, and donor sites can have complications that affect healing and patient comfort. Participants will receive standard wound care on both donor sites, with one site also receiving weekly BL therapy using a medical device for 60 seconds per session over 3-4 weeks. The donor site on the right side will get BL plus standard care, while the left side will receive only standard care. This intra-patient controlled design allows direct comparison of healing between treated and untreated areas within the same patient. During the treatment period, participants will have weekly clinical evaluations including wound observation, pain assessments, skin swabs for infection, and photographic documentation. After complete healing, follow-up visits at 1 and 3 months will assess scar quality and check for late side effects. Safety monitoring will record any adverse reactions related to the blue light treatment throughout the study. The total study duration per participant spans about 4-5 weeks of treatment plus follow-up.

CONDITIONS

Brief Title

Blue Light for Donor Site Healing in Burn Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with intermediate-deep burns with Total Body Surface Area (TBSA) > 10% requiring surgical treatment with escharectomy, presenting at least two donor site areas
  • Patients aged 18 years or older
  • Patients who have signed the informed consent form or whose legal guardian has consented if they are unable to do so themselves
Not Eligible

You will not qualify if you...

  • Patients with intermediate-deep burns with TBSA < 10% or superficial burns
  • Patients under 18 years of age
  • Patients currently participating in other clinical trials involving drugs or medical devices
  • Patients with neoplasms or conditions requiring cytostatic or immunosuppressive drugs
  • Patients with conditions causing skin photosensitivity
  • Pregnant or breastfeeding women
  • Patients or relatives unable to understand the study purposes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - Approximately 3 to 4 weeks depending on healing progression

Participants receive standard wound care on both donor site areas; one area also receives blue light therapy once per week to promote healing.

Weekly visits for dressing changes and clinical evaluations

Follow-up

Duration - Up to 3 months after healing

Participants return for follow-up visits to evaluate scar quality and monitor for late adverse events after wound healing.

2 visits at 1 month and 3 months post-healing (in-person or outpatient clinic)

Trial Site Locations

Total: 1 location

1

U.O. Centro Grandi Ustionati - Osp. Maurizio Bufalini

Cesena, Forlì-Cesena, Italy, 47521

Actively Recruiting

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Research Team

J

Jutta Renate Lehmann, Dr.

D

Davide Griffa, Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Blue light therapy in the management of chronic wounds: a narrative review of its physiological basis and clinical evidence.

Daniel Zhang, Adriel Song Wei Leong, Gabrielle McMullin

https://pubmed.ncbi.nlm.nih.gov/37163654

Effectiveness of Blue light photobiomodulation therapy in the treatment of chronic wounds. Results of the Blue Light for Ulcer Reduction (B.L.U.R.) Study.

Marco Fraccalvieri, Giuseppe Amadeo, Paolo Bortolotti...

https://pubmed.ncbi.nlm.nih.gov/34498454

The effects of photobiomodulation using LED on the repair process of skin graft donor sites.

Rosadélia Malheiros Carboni, Marcela Leticia Leal Gonçalves, Elaine Marlene Tacla...

https://pubmed.ncbi.nlm.nih.gov/34713365

Effect of low-level laser therapy on the healing process of donor site in patients with grade 3 burn ulcer after skin graft surgery (a randomized clinical trial).

Reza Vaghardoost, Mahnoush Momeni, Nooshafarin Kazemikhoo...

https://pubmed.ncbi.nlm.nih.gov/29368069