Photobiomodulation therapy (PBMT) as an adjunct therapy for burn wound care in patients: A pilot study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Time taken for epithelization/ appearance of granulation tissue
研究概览
简要总结
PBMT has been reported to accelerate healing and promote tissue repair in chronic wounds.
A prospective , comparative , single center interventional study is proposed to be conducted at VMMC and Safdarjung hospital, New Delhi. All the patients coming to the department of burns , Plastic and reconstructive surgery, with thermal burns and meeting inclusion criteria will be considered as the study population.
The study shall include 80 patients, with 20 patients in each group.
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Study design; prospective interventional study
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study period;3 months
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Sample size; 80 patients
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Venue:Department of Burns and Plastic Surgery, Dept of Anaesthesia, VMMC and SJH
Patients with second degree superficial and deep burns within 24 hours of injury with TBSA involved (1-5%). Age between 18-65 years, hemodynamically stable will be included in the study.
patients will be divided into 4 groups. Control sham group and 3 study groups. Patients will be managed with standard of care management with PBMT - pulsed 810nm light, 904 nm light, combination of the two.
Time taken for epithelization / healing of wound will be noted
Study duration extended for another 6 months in view of inadequate number of recruitments
the Study was completed on 01/04/2025
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients having second degree superficial or deep dermal burns within 24 hours of injury, with 1.TBSA involved (1-5 %) in the upper or lower limbs, chest, abdomen and back.
- •2.Aged between 18 to 65 years
- •Hemodynamically stable
- •Not taking medication for any ailment.
排除标准
- •Presence of gangrene,
- •Pregnancy
- •Photosensitivity
- •Uncontrolled systemic disease
- •Chronic skin disease
- •Diagnosed uncontrolled mental illness, alcoholism or other addictions.
结局指标
主要结局
1. Time taken for epithelization/ appearance of granulation tissue
时间窗: 12 weeks
次要结局
- 1. Pain : visual analog scale (VAS).(2. Biomarkers in serum: IL-1β, IL-6, TNF-α, Precalcitonin, CRP levels. (on 1st and last visit))
研究者
Dr Sujata Sarabahi
VMMC and Safdarjung Hospital, New Delhi