Outcome analysis of split thickness skin grafting with Dermal regeneration template (Integra) versus Direct split thickness skin grafting for reconstruction of full thickness burn wounds. A prospective, open-labelled pilot study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Scar maturation and assessment of scar after 6 months
研究概览
简要总结
Title: Outcome analysis of split thickness skin grafting with Dermal regeneration template (Integra) versus direct split thickness skin grafting for reconstruction of full thickness burn wounds - a prospective, open labelled pilot study
Research Question: Does application of split thickness skin grafting with a dermal regeneration template (Integra) lead to better scar formation as compared to direct split thickness skin grafting in full thickness burn wounds?
Research Hypothesis: In full thickness burn wounds, application of split thickness skin grafting with dermal regeneration template (Integra) leads to better scar formation and lesser skin graft related complications as compared to direct split thickness skin grafting
Aim: To assess the advantage of split thickness skin grafting with a dermal regeneration template (Integra) over conventional split thickness skin grafting for reconstruction of full thickness burn wounds
Primary objective: To compare outcomes of split thickness skin grafting with Dermal regeneration template (Integra) versus direct split thickness skin grafting in terms of : Maturation of scar at 6 months (according to clinical classification International advisory panel on scar management) and assessment of scar at 6 months (by Hamilton burn scar scale)
Secondary objective: assessment of complications (seroma, hematoma, infection, graft loss) and secondary procedures required (repeat grafting)
Study design: Prospective, open labelled pilot study
Duration: 18 months after ethical clearance
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 1.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with burns wounds presenting to the Department of Burns and Plastic Surgery All India Institute of Medical Sciences Raipur Deep Second degree or third degree depth of burn wounds (Flame burns, scald burns, chemical burns) requiring skin grafting Hemodynamically stable patients Burn wounds with TBSA.
- •minimum 250cm2 BURN WOUNDS WITH TBSA.
- •MINIMUM 250CM2.
排除标准
- •FIRST DEGREE BURNS WOUNDS OR SUPERFICIAL SECOND DEGREE BURN WOUNDS EXTENSIVE BURNS IN PATIENTS WITH HEMODYNAMIC INSTABILITY BURNS PATIENTS WITH INADEQUATE NUTRITIONAL STATUS PATIENTS OR RELATIVES NOT GIVING INFORMED CONSENT.
结局指标
主要结局
Scar maturation and assessment of scar after 6 months
时间窗: Wound healing at discharge and scar maturation and its assessment after 6 months
次要结局
- Complications till complete wound healing(Baseline at surgery & complications within two weeks from surgery)
研究者
Jalaz Joezer Rahmi
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR