跳至主要内容
临床试验/NCT01967836
NCT01967836已完成不适用

Glad Press 'n Seal® as a Temporary Moisture Barrier to Central Lines in Ambulatory Patients

Maureen T Greene8 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
8
主要终点
Patient Subject Questionnaire Post Shower Evaluation

研究概览

简要总结

The purpose of this study is to see if Glad Press 'n Seal works as a moisture barrier for central line that is left in place during ambulatory oncology clinical care.

详细描述

Enrolled subjects will be instructed on the application of the Glad Press 'n Seal product to their IV dressing for use during a shower activity. Practice with application and removal of the product will be supervised by the PI or RA. Questions will be answered and a commercially purchased box of the investigational product will be given to the subject for home use.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

  • Subjects requiring mediport or peripherally inserted central venous catheter line access for 3-5 days
  • Able to read and write English
  • Use showering as a means of home hygiene

排除标准

  • Subjects with eczema/psoriasis at the line insertion area
  • Subjects with active line/site irritation/infection
  • Subjects on chemotherapy protocols including anti-epidermal growth factor receptor drugs (cetuximab, panitumumab) or ipilimumab as there is a high incidence of skin rash as a side effect of these medications
  • Patients who do not intend to shower as a means of home hygiene

结局指标

主要结局

Patient Subject Questionnaire Post Shower Evaluation

时间窗: complete one evaluation after each shower when using product

Percentage of responses to evaluation questions (Percentage reported are "yes" responses) for the following questions. 40 surveys were returned from 11 patient subjects. 1. Did you need assistance to place the Glad Press 'n Seal to your IV area? 2. Was the area covered by the Glad Press 'n Seal dry after taking it off? 3. Was the dressing covering your IV undamaged after taking off the Glad Press 'n Seal? 4. Did you feel the IV Line was accidentally pulled at all with the use of the Glad Press 'n Seal? Likert Scale response to the following question On a scale of 0 (would not use) to 10 (would continue to use) how satisfied were you in using Glad Press n Seal?

Patient Satisfaction Mean on a 0-10 Likert Scale on the Use of Glad Press 'n Seal During Showering. 40 Subjects Reports.

时间窗: Reported afer each subject showering survey completion

0 Not at all satisfied 10 Very satisfied

次要结局

  • Clinic Nurse Observation of Subjects, Who Used Intervention Device, at the Next Clinic Visit(Inspection of central line site and dressing upon return to schduled clinic visit up to 30 days)

研究者

发起方
Maureen T Greene
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Maureen T Greene

Maureen T. Greene, PhD, RN

Wheaton Franciscan Healthcare

研究点 (8)

Loading locations...

相似试验