A pilot observational study to evaluate the safety and efficacy in delivery of the donor skin segment using spray gun on the donor site
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- a. Spray area to the harvested donor area ratio on the donor site
研究概览
简要总结
This study aims to evaluate the use of a spray gun to apply donor skin segments during skin grafting. It is a pilot interventional study designed to assess both the effectiveness and safety of this method for healing donor sites.
The primary goal is to see how well the spray gun promotes healing of the skin graft donor area. The secondary goal is to determine whether this method is safe for patients. The study is being conducted by the Departments of Plastic Surgery and Pharmacology at KMC Manipal.
Participants will include hospitalized adults undergoing split-thickness skin grafting. One half of their donor wound will be treated using the spray gun, while the other half will heal using traditional methods. The study will observe healing progress, pain levels, and any complications for up to 10 days.
The potential risks include graft failure, infections, and pain. However, the study aims to confirm the benefits of quicker healing and less pain when using this spray method compared to traditional grafting approaches. Ethical considerations and patient confidentiality are addressed, and compensation for any trial-related injury is provided.
The sample size is small (30 participants), and results from this pilot study could help fill research gaps on more efficient and safer skin grafting techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults 18 years and above, any sex, willing to provide a written informed consent.
- •[Women must be of no child-bearing potential or must have tested Negative for UPT] Female participants can be considered not of childbearing potential only if they are with current bilateral tubal ligation or occlusion, or post-hysterectomy, or post-bilateral ovariectomy, or post-menopause.
- •Patients who are hospitalized and in whom Split thickness skin graft is harvested
- •The participant/ Legally acceptable representative is willing to give written informed consent.
排除标准
- •Patients who are critically ill
- •Documented skin disease at the time of enrollment as judged by the investigator
- •Treatment with immunosuppressants
- •Women who are pregnant or breast feeding
- •Inclusion in other ongoing study at present that would preclude the subject from participating in this study as judged by the investigator
- •Any other pathology that in the investigators opinion might interfere with the current study.
结局指标
主要结局
a. Spray area to the harvested donor area ratio on the donor site
时间窗: Days 5 7 and 10
b. Area of epithelialization
时间窗: Days 5 7 and 10
c. Percentage of epithelialization measured with imaging software in order to compare with the initial wound area.
时间窗: Days 5 7 and 10
次要结局
- a. Incidence of infection/ Discharge(b. Delay in healing due to complications)
- VAS Pain score(Days 5 7 and 10)
研究者
Dr Joseph Thomas
Kasturba Medical College Manipal