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临床试验/NCT04344483
NCT04344483已完成不适用

Effect of Lidocaine and Adrenaline Soaked Gauze Versus Normal Saline Soaked at Skin Graft Donor Site of Thigh: A Randomized Control Trial

Dow University of Health Sciences1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年12月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Post operative bleeding

研究概览

简要总结

Investigator is studying the effects of Lidocaine and Adrenaline Soaked Gauze vs Normal Saline Soaked Gauze at Skin Graft Donor Site of Thigh.

Haemostatic effect, epithelization and post operative pain will be assessed on follow up.

详细描述

After admission participants will be randomized either to be in Group A or Group B. Closed envelop technique will be used for random assignment of the patients.

Group A will be receiving 2% lidocaine and 1:100,000 adrenaline soaked gauze while group B will be given only normal saline soaked gauze at donor-site for ten minutes.

The primary end point of study is intraoperative bleeding. The secondary end points of study include no. of dressings required in first 24 hours after surgery, donor site epithelization at 14th post-operative day, post-operative pain in first 24 hours after surgery along with systemic analgesia requirement after surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients will be recruited in the study by closed envelope technique and the study will be single blinded.

入排标准

年龄范围
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients of both the gender of age > 15 years
  • Multiple donor-sites

排除标准

  • Bleeding disorder
  • Concomitant injuries
  • Donor site other than thigh
  • Previously harvested donor-site
  • Patients on antiplatelet medications

研究组 & 干预措施

Group B ( Normal Saline)

Placebo Comparator

Group B patients will receive normal saline soaked gauze over skin graft donor site of thigh intraoperatively for 10 minutes. After 10 minutes this dressing will be removed and sufratul dressing will be applied over donor site

干预措施: Normal saline (Drug)

结局指标

主要结局

Post operative bleeding

时间窗: 24 hours

post operative bleeding will be assesd in post operative period by number of dressings required.

Intra operatieve bleeding

时间窗: per operative

Intra-operative Bleeding from donor site of graft will be assessed per operatively as being normal or more than normal.

Post operative pain

时间窗: 24 hours

post operative pain will be assessed in the post operative period by visual analog score. Score ranges from 0 to 10 with 0 indicating no pain whereas 10 is worst pain.

Analgesia requirement

时间窗: 24 hours

Post operative analgesia requirement of patient will be observed by number of medications required

次要结局

  • Epithelization of donor site(14 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zaara Zahid

Principle investigator

Dow University of Health Sciences

研究点 (1)

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