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临床试验/NCT02458989
NCT02458989Unknown不适用

A Randomized Controlled Trial Comparing The Cosmetic Outcome Of Electrocautery Versus Scalpel For Thyroidectomy Incisions

Dr. Sam M. Wiseman2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Appearance of surgical scar

研究概览

简要总结

This study looks at the difference in surgical scar outcomes between two different surgical incision methods during thyroid surgery: scalpel vs electrocautery. Patients who are already scheduled for thyroid surgery with Dr. Sam Wiseman, Endocrine Surgeon at St. Paul's Hospital, and that meet the eligibility criteria for this study will be invited to participate. After signing the informed consent form, participants will be randomized into either one of the two incision methods, but will not know which one they receive. There will be two follow-up time points: one at 6 and another at 12 months post-operative. At these time points the research team will send a letter to the participant asking them to rate the appearance of their surgical scar. They will also be asked to take a picture of their scar and send it back to the research team, so that the research team can make an assessment of their surgical scar. The study concludes when the 12 month follow-up is complete.

详细描述

Purpose:

To evaluates the difference in thyroid cosmesis between two different surgical incision methods during thyroidectomy: scalpel vs electrocautery.

Hypotheses:

The investigators' hypotheses is that there is no difference in the cosmetic outcome of surgical incision during thyroidectomy by either a scalpel or electrocautery.

Justification:

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 (Participant)

入排标准

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

入选标准

  • Patients over 18 years old who have consented to conventional thyroid surgery with Dr. Sam Wiseman at St Paul's Hospital (Vancouver, BC) will be asked to participate.

排除标准

  • Patients will be excluded if they have had prior surgical incisions at the site of expected surgical incision, connective tissue disorders (e.g. Ehrlos Danlos syndrome), known keloid predilection, and lack of informed consent.

结局指标

主要结局

Appearance of surgical scar

时间窗: 12 months post operative

次要结局

  • Rate of wound infection(12 months post operative)

研究者

发起方
Dr. Sam M. Wiseman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Sam M. Wiseman

Principal Investigator

St. Paul's Hospital, Canada

研究点 (2)

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