Comparison Between Effect of Adrenaline and Without Adrenaline in Tumescent Solutions on Bleeding Control of Skin Graft Donor Site.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- ordinal scale
研究概览
简要总结
The purpose of this study is to appraise if various concentration of adrenaline containing tumescent has any significant role in bleeding at skin graft donor site bleeding through photographic assessment.
详细描述
Tumescent solutions will be prepared by adding 30cc of Ringer's lactate and 10cc of lignocaine 2%, with 1cc of adrenaline of 1:200,000 (which will be prepared by adding 1cc of adrenaline of 1:1000 conc. with 200ml of normal saline marked as solution "A" and without adrenaline marked as solution "B" to form the two different tumescent solutions. Both solutions with be topically applied in soaked gauzes for around 10 minutes. Solution A will be applied over the anterior side of thigh while solution B will be applied over lateral side of thigh.
Tumescent solutions will be prepared around 10 minutes before applying. After 10 min Split-thickness skin graft donor sites will be harvested with a Dermatome adjusted on with a randomized setting to harvest a fixed depth of wound depth. After harvesting skin graft the donor site wound will be photographed.
The apparent severity of bleeding will be scored on an ordinal scale from 0 to 5 (0=no bleeding/staining, 1=minimal bleeding/staining, 2=mild bleeding/staining, 3=moderate bleeding/staining, 4=moderately severe bleeding/staining, 5=severe bleeding/staining by two independent surgeons. At last photographs will be compared with pre-infiltration records in each side. Skin graft donor and recipient site will be inspected on the 5th post-operative day
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age above 18 years
- •both genders
- •non hypertensive patients
- •Hemoglobin levels more than 10 g/dl
- •Platelet count above 150 x 10E9/L
- •Wounds for more than 6 weeks
排除标准
- •• Hypertensive patients,
- •Bleeding tendencies (Disorder),
- •Immune-compromised,
- •Familial history of bleeding
研究组 & 干预措施
Tumescent with adrenaline
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution containing adrenaline.
干预措施: tumescent with adrenaline (Other)
Tumescent without adrenaline
skin graft donor site of patients recurited in this group will be injected subcutaneously with tumescent solution not containing adrenaline.
干预措施: tumescent without adrenaline (Other)
结局指标
主要结局
ordinal scale
时间窗: 30minutes
The apparent severity of bleeding will be scored on an ordinal scale from 0 to 5 (0=no bleeding/staining, 1=minimal bleeding/staining, 2=mild bleeding/staining, 3=moderate bleeding/staining, 4=moderately severe bleeding/staining, 5=severe bleeding/staining by two independent surgeons.
次要结局
未报告次要终点
研究者
Mahak Ali
MahakA
Dow University of Health Sciences