Blue Light in the Treatment of Donor Site in Burn Patient: a Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Donor Site Healing Time
研究概览
简要总结
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.
详细描述
Burn injuries frequently require surgical treatment with split-thickness skin grafting. This procedure involves harvesting skin from a healthy area of the body, commonly referred to as the donor site (DS). Although donor sites are considered superficial wounds, their healing process can be associated with clinically relevant complications, including delayed re-epithelialization, pain, inflammation, and risk of infection. These complications may prolong hospitalization, negatively affect patient comfort and quality of life, and influence the overall outcome of burn management. Therefore, strategies that may accelerate DS healing while maintaining safety and tolerability are of considerable clinical interest.
Photobiomodulation with blue light (BL) has emerged as a promising therapeutic approach in the management of several types of skin wounds. Experimental and clinical evidence suggests that BL may exert antimicrobial effects, modulate inflammatory processes, and stimulate tissue repair mechanisms involved in wound healing. These biological effects could potentially support faster re-epithelialization and improved wound bed conditions. However, clinical evidence specifically addressing the role of BL therapy in DS healing among burn patients remains limited.
This clinical investigation aims to evaluate the clinical effectiveness and safety of BL photobiomodulation when used in addition to the Standard of Care (SoC) for the treatment of DS wounds in patients undergoing skin grafting for burn injuries.
Study Design The study is designed as an interventional, controlled, prospective, single-center post-market clinical study. The intervention involves the use of a CE-marked medical device (EmoLED) that emits blue light and is already approved and routinely used in clinical practice in accordance with the manufacturer's indications and applicable regulatory standards.
The study will enroll 25 patients with intermediate or deep burn injuries who require surgical treatment with split-thickness skin grafting and who present at least two DS areas suitable for comparative evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
Experimental treatment
Standard treatment + Blue Light
干预措施: Photobiomodulation with blue light (Device)
Standard Treatment
Standard Treatment
结局指标
主要结局
Donor Site Healing Time
时间窗: From enrollment to the end of treatment at 4-5 weeks
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.
次要结局
- Signs of Infection(From enrollment to the end of treatment at 4-5 weeks)
- Local Adverse Reactions(From enrollment to the end of treatment at 4-5 weeks)
- Wound Bed Score (WBS)(From enrollment to the end of treatment at 4-5 weeks)
- Numeric Pain Rating Scale (NRS)(From enrollment to the end of treatment at 4-5 weeks)
- Vancouver Scar Scale (VSS)(1 and 3 months after healing)