Skin Graft Harvesting and Application by indigenously developed Spray Gun technique on Post Traumatic Raw areas: A Pilot study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- a Spray-to-Donor Area Ratio: Ratio of the sprayed area to the harvested donor skin area applied to the wound site.
研究概览
简要总结
This prospective, interventional pilot study will investigate the effectiveness of spray gun-assisted autologous skin grafting in accelerating healing in traumatic wounds. With the increasing burden of complex traumatic injuries in low-resource settings, there will be a pressing need to enhance wound healing outcomes while minimizing donor site morbidity. The spray gun method will allow uniform distribution of minced skin grafts, enabling significant expansion of donor skin and promoting early epithelialization. The study will be conducted at AIIMS Trauma Centre and will enroll 30 adult patients who will meet the inclusion criteria for split-thickness skin grafting (STSG). Each patient will serve as their own control. One half of the STSG donor site will be treated with the spray technique, while the other half will receive standard care. The primary endpoints will include graft take percentage, degree and rate of epithelialization, and pain assessment. Secondary parameters will include infection rates, dressing frequency, and analgesic requirements.
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 65.00 Year(s)(—)
- 性别
- All
入选标准
- •1 Patients who are hospitalized and in whom Split thickness skin graft is harvested 2 Patients presenting exclusively with traumatic wounds.
排除标准
- •1 Critically ill patients 2 Presence of skin disease at the time of enrolment 3 Treatment with immunosuppressants 4 Pregnant/lactating women 5 Concurrent participation in other studies.
结局指标
主要结局
a Spray-to-Donor Area Ratio: Ratio of the sprayed area to the harvested donor skin area applied to the wound site.
时间窗: Follow up at day 3,day 5, day7,day10, day14 and 6 weeks
b Graft Take Rate: Percentage of graft uptake, defined as the ratio of epithelialized graft area to the total grafted area, assessed on postoperative Day 10
时间窗: Follow up at day 3,day 5, day7,day10, day14 and 6 weeks
c Epithelialized Area: Measurement of the area of epithelialization on Days 5, 7, and 10 postoperatively.
时间窗: Follow up at day 3,day 5, day7,day10, day14 and 6 weeks
d Percentage of Epithelialization: Quantification of epithelialization on Day 10 using imaging software, expressed as a percentage of the initial wound area
时间窗: Follow up at day 3,day 5, day7,day10, day14 and 6 weeks
次要结局
- a Incidence of Infection/Discharge: Presence of infection or wound discharge up to Day 10 or until patient discharge, whichever occurs earlier.(b Delayed Healing Due to Complications: Occurrence of delayed wound healing attributable to any complications observed up to Day 10 or until discharge.)
研究者
Dr Sushma Sagar
JPNATC AIIMS
