Effectiveness and Clinical Application of MolecuLight Bacterial Fluorescence Imaging in Wound Debridement
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Percentage of residual bacterial light spots
研究概览
简要总结
MolecuLight is a device that utilizes a special light which, when used on wounds, helps identify the regions which pathogenic bacterial counts are the highest. The device applies 405nm violet light which is harmless to the human tissue. When specific components in bacteria catches up the light, a photoluminescent reaction is triggered and the fluorescence light is caught by the camera on this device in real time.
When treating an infected wound which requires debridement and/or reconstruction, traditionally surgeons rely on many clinical clues to judge the severity and region of infection. However, these clues, such as lab data, vital signs, bacterial culture growth, or infection symptoms/signs, are usually indirect and also require several days to be fully interpretated.
The advantage of MolecuLight is its simple, direct, real-time, and flexible application, which is very important and valuable when treating an infected wound. We aim to add this device to our routines and see if the treatment course for these wounds can be more rapid and effective, and also utilize the countless potential of immediate bacterial identification in numerous aspects of our work.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with wounds that present obvious symptoms or/and signs of infection, and chronic wounds that have failed to heal or improve for 14 days (Chronic wounds are often complicated or caused by wound infection)
- •Patients that are scheduled for surgical treatment for the wound
- •Patients that are older than (including) 20 years and younger than (including) 85 years.
- •Wounds with a size larger than 1x1 cm2
排除标准
- •Wounds that heal within 14 days.
- •Patient is unable to continue further surgical treatment due to any reason
- •The wound site is amputated
- •Patient refuses further surgical treatment
- •The patient has an active malignancy currently under treatment
- •Patient is immunocompromised or currently under systemic steroid treatment
- •The wound had been treated by radiation
- •The patient refuses to participate in this study
结局指标
主要结局
Percentage of residual bacterial light spots
时间窗: Immediately after each debridement within surgery
The percentage of residual bacterial light spots. After each debridement, we use MolecuLight to evaluate the residual shinny area (post-debridement shinny area/pre-debridement shinny area)
Numbers of Re-debridement
时间窗: Immediately after each surgery
If the bacterial shinny area after debridement \> 10% wound area, the debridement will be performed again until \< 10% residual bacterial shinny area
Duration of wound healing
时间窗: Time of complete epithelialization without drainage
Time of complete epithelialization without drainage
次要结局
- Incidence of surgical complications(8 weeks postoperatively)
- Antibiotic use(8 weeks postoperatively)
- Duration of antibiotic use(8 weeks postoperatively)
研究者
Chang shun cheng
Director of Wound Care Center and Department of Plastic Surgery
Taipei Medical University Shuang Ho Hospital