A comparison of efficacy of early versus late excision and grafting in patients with acute burn- Open label randomised controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To Compare SOFA score of burns in early vs late excision and grafting in acute burns
研究概览
简要总结
Title: A Comparison of Efficacy of Early vs Late Excision and Grafting in Patients with Acute Burns – Open Label Randomized Controlled Study Candidate: Dr. Akshat Kakani, M.Ch (Plastic, Reconstructive, and Burns Surgery) Institution: AIIMS Rishikesh
**Introduction:**Burn injuries often require surgical intervention for optimal recovery. Early excision and grafting (EEG) have shown benefits in infection control, hospital stay reduction, and functional preservation. However, factors like late presentation and resource limitations hinder its widespread application. This study aims to compare EEG with late excision and grafting (LEG) in managing acute burns.
Objectives:
- Primary Objective: Compare SOFA scores on day 10 between early and late excision groups.
- Secondary Objectives:
- Compare hospital stay duration.
- Assess graft uptake on postoperative day 7.
- Compare mortality rates between the two groups.
Methodology:
- Study Design: Open-label randomized controlled trial
- Setting: Department of Burns & Plastic Surgery, AIIMS Rishikesh
- Duration: 18 months
- Sample Size: 36 patients (18 in EEG group, 18 in LEG group)
- Inclusion Criteria:
- Patients aged 18–60 years
- Total Body Surface Area (TBSA) burns between 10–40%
- Thermal, electrical, or chemical burns
- Hemodynamic stability
- Exclusion Criteria:
- Comorbid conditions (diabetes, hypertension, CKD, CLF)
- Additional trauma preventing anesthesia clearance
- Inhalational injuries
- Interventions:
- EEG Group: Surgery within 7 days of injury.
- LEG Group: Initial wound care, surgery delayed until bed is suitable for grafting.
- Randomization & Blinding: Participants will be randomly assigned using random envelope method. Open-label design.
- Outcome Measures:
- SOFA score on day 10
- Length of hospital stay
- Functional outcomes (clinical assessment)
- Mortality rates
- Graft uptake on postoperative day 7
Statistical Analysis:
- Student t-test for SOFA score and hospital stay comparison.
- Chi-square test for mortality rates.
- Significance level: p < 0.05
- Software: SPSS version 25
Ethical Considerations:
- Institutional Ethics Committee (IEC) approval obtained.
- Written informed consent from participants.
- No financial burden on participants.
**Conclusion:**This study aims to provide evidence on the efficacy of early excision and grafting in acute burns, potentially influencing standard burn management protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Total burns surface area 10-40 % second degree deep to third degree burns Thermal, chemical, electric burns Hemodynamic stability.
排除标准
- •Known co morbidties ( Diabetes mellitus, Hypertension, Chronic kidney disease, Chronic liver failure) Total burn surface area less than 10% and more than 40 % Inhalational Injury Additional trauma not getting pre anaesthesia clearance.
结局指标
主要结局
To Compare SOFA score of burns in early vs late excision and grafting in acute burns
时间窗: Baseline | 2 weeks
次要结局
- To compare length of hospital stay in early vs late excision and grafting in acute burns(Day of admission to day of discharge)
- To compare graft uptake on post operative day 7 in early vs late excision and grafting in acute burns(Post operative day 7)
- To Compare mortality in early vs late excision and grafting in acute burns
研究者
Akshat Kakani
AIIMS Rishikesh