NCT04965883Unknown不适用
Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- compare the cost of treatment in both groups
研究概览
简要总结
- All the patients will be included in the study will be resuscitated on arrival in our department.
- Detailed history will be taken and burn evaluation will take place in respect to TBSA according to Lund and Browder chart and burn depth.
- Dreesing will be done with topical antimicrobial agent.
- Fluid resuscitation with lactated Ringer's solution according to modified Parkland's formula.
- Injectable proton pump inhibitors, and analgesics will be started as initial drug therapy.
- Close follow up of the patients will be done then evaluation of the patients will be done in the fourth day and dividing the patients into two groups: the first group "early exicion and grafting " and the second group " dressing and delayed grafting ".
- The first group will include patients with early surgery from 4 to 10 days since burn.
- Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn.
- Then the data will be collected and analyzed for comparison between the two groups regarding : the timing of operation and its relation to the length of stay, functional outcome and cost of treatment
详细描述
- The first group will include :
- Patients with good general condition and hemodynamically stable that fit for early surgery.
- Patients that accept the option of early surgery and can give consent for it .
- Patients with available donor site for early grafting.
- Patients with burn at certain sites may be of priority for early excision and grafting to avoid long term complication of delayed wound healing such as : on joint surface, hands, feet, and face.
- The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time.
- The first dressing will be in the fifth day post operative.
- In the other hand the second group will include:
- Patients with bad general condition or hemodynamicaly unstable at the early excision period (4-10 days post burn).
- Patients that refuse early surgery and give no consent for early surgery.
- Patients with no available donner site for early excision and grafting during the fourth day evaluation .
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who had deep second and third degree burns.
- •patients with flame and scald burns.
排除标准
- •Patients who had only first or superficial second degree burns.
- •patients with high voltage contact electric burns and chemical burns.
研究组 & 干预措施
Early Excision and Grafting
Experimental
- The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time.
- The first dressing will be in the fifth day post operative.
干预措施: Excision and Grafting (Procedure)
Dressing and Delayed Grafting
Experimental
• Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn.
干预措施: dressing then delayed grafting (Procedure)
结局指标
主要结局
compare the cost of treatment in both groups
时间窗: one year
regarding how much money will be used since burn upto recovery measured by filling questionnaire by the patients.
Compare the number of blood units needed in both groups ( the first group : early exicion and grafting , the second group : dressing and delayed grafting )
时间窗: one year
We will estimate how many blood units needed in both groups since admission upto discharge from hospital.
次要结局
- Compare the length of hospital stay between of early excision and grafting(EEG) versus dressing and delayed grafting(DDG) of deep burn.(one year)
研究者
Shenoda Gamel Fayez
resident doctor at plastic surgery department sohag university hospital
Sohag University
研究点 (1)
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