Effect of Autologous Fat Grafting and Nanofat Usage on Burn Wound Healing and Early Scarring
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- wound healing time
研究概览
简要总结
the study evaluates the role of autologous fat grafting and the usage of nanofat in the treatment of the acute burn injuries in different genders and its influences on the healing time and hospital stay, pain control, the need and take of a split thickness skin graft and its size, and the end resulting early scarring, in comparison with control group that were treated with traditional methods, so as to find out new method of treating burn injuries and decreasing its morbidity.
详细描述
as the patient is admitted, full evaluation locally ( as regard the wound itself and the areas of fat harvesting) and generally (assessment of the general condition) is done, fluid resuscitation is started as the unit protocol hand in hand with the analgesia and other medications prescribed according to the unit protocol.
the patient's general condition is optimized for surgery of the fat extraction and grafting which typically should be within the first 6 days of admission.
then under anesthesia (any possible type from local and regional up to general anesthesia) liposuction procedure is performed, then fat is processed then grafted at the wound site with other portion prepared as nanofat for topical use and wound coverage, then sterile dressing is applied.
typically follow up is held daily with the dressing change day after another with the use of the nanofat only and sterile dressing
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
- None
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both males and females within the age frame are candidates.
- •previously healthy individuals with no co-morbid conditions e.g cardiac, hepatic, diabetic, vascular or renal disease.
- •with TBSA of 10 to 30% affected and of deep dermal to full thickness wound depth, at any part of the body except the genitalia, perineum or the perianal region or those with inhalational injury.
排除标准
- •other patients aged younger or older than the specified age group.
- •patients with co-morbid conditions.
- •patients with smaller or larger BSA than the specified BSA.
- •burns involving the genitalia, perineum or the perianal region and patients with inhalational injury.
研究组 & 干预措施
control group
this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine
干预措施: Topical Cream (Drug)
control group
this group of patients are treated with the regular conventional methods like application of topical agents e.g silver sulphadiazine
干预措施: split thickness skin grafting (Procedure)
fat grafting group
this group of patients will have the autologous fat grafting for their burn wounds
干预措施: autologous fat grafting (Procedure)
fat grafting group
this group of patients will have the autologous fat grafting for their burn wounds
干预措施: split thickness skin grafting (Procedure)
结局指标
主要结局
wound healing time
时间窗: one to three weeks
the effect of the fat grafting on the wound healing time
次要结局
- effect on pain perception, subjective assessment scale(immediate post-operative and up to three weeks)
研究者
Ahmed Mohamed Abouzaid
specialist plastic, reconstructive surgery and burn therapy
Abouqir General Hospital