New Treatment for Donor Sites
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- epidermal regeneration (donor site healing)
研究概览
简要总结
Primary research questions/Purpose of the Research.
- Determine the short term (epidermal regeneration, reduction of pain, infections and length of stay) and long term (scarring, long term recovery, and cost of treatment) outcomes of Microbial Nanocellulose (NC) and fine mesh gauze impregnated with hyaluronan and thrombin (HT).
- Determine if donor site treatment with NC and HT is as safe as the use of Scarlet Red ointment dressing.
b. Describe the importance of the knowledge that you expect to gain from the research.
To find a donor site dressing that has outcomes equal or better than that of scarlet red.
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
- 1 Day 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 0-90 years.
- •Any patient admitted to the hospital with burn injury requiring grafting and a donor site.
排除标准
- •Patient with severe burn injuries expected to die.
研究组 & 干预措施
1
Microbial Nanocellulose (NC), an inert material produced by Acetobacter xylinum is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)] (Drug)
1
Microbial Nanocellulose (NC), an inert material produced by Acetobacter xylinum is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Blood sample (Procedure)
1
Microbial Nanocellulose (NC), an inert material produced by Acetobacter xylinum is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Biopsy (Procedure)
2
fine mesh gauze impregnated with hyaluronan and thrombin (HT) is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)] (Drug)
2
fine mesh gauze impregnated with hyaluronan and thrombin (HT) is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Blood sample (Procedure)
2
fine mesh gauze impregnated with hyaluronan and thrombin (HT) is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Biopsy (Procedure)
3
Scarlet Red is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Application of donor site dressing [scarlet red, Microbial Nanocellulose (NC), or hyaluronan and thrombin (HT)] (Drug)
3
Scarlet Red is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Blood sample (Procedure)
3
Scarlet Red is one of three drug interventions the patient will be randomized to receive. One of the three drugs will be placed on a patient donor site immediately after harvesting skin while the patient is in surgery.
干预措施: Biopsy (Procedure)
结局指标
主要结局
epidermal regeneration (donor site healing)
时间窗: Days 3-14 post surgery
次要结局
- Infection(Days 0-21 post surgery)
- reduction in pain of donor site(Day 0-21 post surgery)
- Scarring(Day 7 post surgery to 2 years post surgery)
- Costs(Admission post burn injury to 2 years post burn injury)