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临床试验/NCT03937765
NCT03937765终止不适用

The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites

University of Arizona2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
25
试验地点
2
主要终点
Patient post-operative donor site pain.

研究概览

简要总结

The purpose of this study is to compare post-operative skin graft donor site pain between those treated with standard wound care vs PRP. Secondarily the study is designed to compare time to complete donor site healing. The null hypothesis is that here is no difference in post-operative donor site pain between those treated with standard wound care and PRP. The secondary null hypothesis is that there is no difference in time to donor site healing.

详细描述

A well-known complaint after a split thickness skin graft surgery is pain at the graft donor site. In our patients, it has been have noticed those whose donor sites have been treated with platelet rich plasma (PRP) have endorsed decreased pain compared to those who have not. During our literature review few studies have looked at this issue. One such study by Miller et. al. looked at 5 patients whose donor site was treated with PRP showed a significant decrease in pain on a Likert visual pain scale. Kakudo et al. performed a side-by-side comparison on a single patient with half the wound treated with PRP and the other as a control. They found better epithelization and reduced pain during dressing changes for the treatment group. Both of these studies show promising results for pain reduction with PRP use, unfortunately there are no high quality randomized control trials that have looked at this. Another issue is many studies on PRP assess reduction of pain as a secondary outcome and instead focus on wound healing and epithelization primarily.

This study hopes to elucidate the effect of PRP application on graft donor site pain. Patients will be recruited to the study and randomized into either treatment or control group based on medical necessity for a skin graft. This study will assess pain at the donor site via Likert pain scale and monitor narcotic pain medication use.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any patient requiring a split thickness skin graft and is above the age of 18.

排除标准

  • Medical history of chronic pain at the donor site
  • Inability to follow up
  • Unable to participate in pre or post operative questionnaire inclusive of organic
  • Traumatic, chemical or degenerative causes of altered mental sensorium
  • Age <18.

结局指标

主要结局

Patient post-operative donor site pain.

时间窗: Through study completion, an average of 1 year

Donor site pain according to the visual analog scale score. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Duration of donor site wound

时间窗: Through study completion, an average of 1 year

Duration of wound care after surgery

Opioid consumption

时间窗: Through study completion, an average of 1 year

Opioid consumption after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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