Blue light to speed healing of donor-site wounds after skin grafts
Blue Light in the Treatment of Donor Site in Burn Patient: a Controlled Clinical Trial
This study will try adding blue light therapy to usual care to see if donor-site wounds heal faster and with less pain or infection in adults with intermediate-to-deep burns who need skin grafts.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AUSL Romagna Rimini Academic / other |
| Locations | 1 site (Cesena, Forlì-Cesena) |
| Trial ID | NCT07453927 on ClinicalTrials.gov |
What this trial studies
Adults with intermediate-to-deep burns who require split-thickness skin grafting and have at least two donor sites will receive standard care on one donor area and standard care plus blue light photobiomodulation on another, allowing within-patient comparison. Investigators will measure time to re-epithelialization, wound condition, pain scores, signs of infection, safety and tolerability, and longer-term scar quality. The intervention consists of noninvasive blue light applied in addition to routine postoperative dressings over the donor-site healing period. The trial is conducted at the burn center of Osp. Maurizio Bufalini in Cesena, Italy.
Who should consider this trial
Good fit: Adults (over 18) with intermediate-to-deep burns covering more than 10% TBSA who require surgical escharectomy and have at least two donor sites are the intended participants.
Not a fit: Patients with superficial burns or TBSA under 10%, those with photosensitivity, patients on cytostatic or immunosuppressive therapy, pregnant or breastfeeding women, or those otherwise ineligible are unlikely to be candidates or to receive benefit from this protocol.
Why it matters
Potential benefit: If successful, blue light could shorten donor-site healing time, reduce pain and infection risk, and improve long-term scar appearance.
How similar studies have performed: Preclinical studies and some clinical reports indicate blue light can have antimicrobial and wound-healing effects, but controlled data specifically for donor-site healing in burn patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 this trial is running
Cesena, Forlì-Cesena
- U.O. Centro Grandi Ustionati - Osp. Maurizio Bufalini — Cesena, Forlì-Cesena, Italy (Recruiting)
Study contacts
- Study coordinator: Jutta Renate Lehmann, Dr.
- Email: juttarenate.lehmann@auslromagna.it
- Phone: +39 3391023866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.