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临床试验/NCT01372488
NCT01372488已完成不适用

Are Patients Willing and Capable of Removing Their Own Non-absorbable Sutures

Fraser Health1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2010年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
160
试验地点
1
主要终点
Are patients willing and capable of removing their own non-absorbable sutures?

研究概览

简要总结

  1. Hypothesis

If patients who are sutured with non-absorbable sutures in the Emergency Department (ED) are provided with the proper equipment and knowledge on how to remove their own sutures, they will be willing and capable of removing their own sutures. 2. Primary and Secondary Questions

Primary Question What number of patients in the study group will successfully remove their own sutures if they are provided with the equipment and information on how to do so compared with a control group who are treated and advised in the usual fashion? (follow up with family doctor or local medical clinic for suture removal)

Secondary Questions

  1. Number of complications related to self removal of sutures as compared to traditional treatment. Complications measured were wound infections, dehiscence and prolonged bleeding (>30 min)
  2. Number of physician visits related to self removal of sutures as compared to traditional treatment.
  3. Patient satisfaction and comfort level related to self removal of sutures as compared with traditional treatment.

详细描述

Introduction/Background:

Patients who are sutured with non-absorbable sutures in the Emergency Department are asked to follow up with their family doctor or local medical clinic for suture removal. Suture removal, especially for simple lacerations is easy to do. Given the proper instructions and equipment suture removal could be done by the patient or a family member.

Objectives:

Are patients willing and capable of removing their own non-absorbable sutures? How many patients can successfully self remove their own sutures if given the proper equipment and instructions as compared with patients who are not given equipment and instructions? Would patient self removal result in less physician visits related to sutured wounds? What would be the complication rate for self removal of sutures be? Specific complications were wound infection, dehiscence and prolonged bleeding? Would patients be satisfied and comfortable in taking out their own sutures?

Methods:

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
Single (Investigator)

入排标准

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

入选标准

  • •Patients 19 years and older that have wounds sutured in the ER with non-absorbable sutures

排除标准

  • •Inability to give consent secondary to alcohol, drugs or failure to speak English
  • •Complicated lacerations or lacerations which require close medical supervision
  • •Lacerations that are inaccessible to the patient (ie. scalp, back or buttock lacerations)
  • •Inability to contact patient by telephone for follow-up (no telephone, patient travelling out of country etc.)
  • •Patients who are immunocompromised, have diabetes mellitus or are on steroid medications

研究组 & 干预措施

Study group

Active Comparator

Study group will be provided with suture removal instructions and suture removal kit and asked to consider removing their own sutures

干预措施: Suture self removal (Procedure)

Control group

Placebo Comparator

Control group will be asked to have their sutures removed as they normally would (see family doctor or clinic)

干预措施: Suture removal by family doctor or clinic (Procedure)

结局指标

主要结局

Are patients willing and capable of removing their own non-absorbable sutures?

时间窗: 3 months

What number of patients in the study group will successfully remove their own sutures if they are provided with the equipment and information on how to do so compared with a control group who are treated and advised in the usual fashion? (follow up with family doctor or local medical clinic for suture removal)

次要结局

  • Physician Visits Related to Suture Self Removal(3 months)
  • Complications related to self removal of sutures(3 months)
  • Patient Comfort and Satisfaction with Self-Removal of Sutures(3 months)

研究者

发起方
Fraser Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter MacDonald

Emergency Physician

Fraser Health

研究点 (1)

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