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临床试验/NCT06059417
NCT06059417已完成不适用

Foam Tape Allergy a Sticky Situation

CHRISTUS Health4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
4
主要终点
Cutaneous Irritancy Scoring System

研究概览

简要总结

Foam tape is commonly used in the emergency department as a dressing over chest tubes owing to its occlusive and compressible properties. There is a paucity of data regarding the incidence of significant cutaneous reactions to this material. The investigators conducted a prospective trial to evaluate the incidence of dermatitis following application of foam tape to the upper arm of a cohort of healthy volunteers.

详细描述

This was a prospective, interventional trial. The investigators enrolled a cohort of consenting, healthy physicians, nurses, and ancillary staff at a teaching facility who did not have known hypersensitivity to foam tape. Study investigators applied a 2x2 inch piece of 3M micro-foam adhesive to the medial aspect of each subject's upper arm. The contralateral arm served as a reference for comparison. The adhesive remained in place for 48 hours and the study authors assessed patients utilizing the previously validated Cutaneous Irritancy Scoring System (CISS). Categorical variables analyzed by chi-square, continuous variables with t-tests.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 70
  • No reported history of dermatologic conditions
  • No active dermatologic lesions
  • Able to provide written consent to participation in the study.
  • Resident and/or ancillary staff

排除标准

  • Hospitalized patients
  • Adults unable to consent.
  • Prisoners
  • Adults with anaphylaxis to medical adhesives

结局指标

主要结局

Cutaneous Irritancy Scoring System

时间窗: 48 hours

A score will be assigned to the test area using the established Cutaneous Irritancy Scoring System. Using an established scoring system grading based on erythema and edema, a cumulative score will be obtained by adding erythema and edema. A score of 0 is no reaction. A score of 1-3 is mild, 4-5 is moderate, and 6-8 severe.

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 (4)

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