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临床试验/NCT04635696
NCT04635696已完成4 期

Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy

ProMedica Health System1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年1月7日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Patient-reported post procedure pain

研究概览

简要总结

Negative pressure wound therapy (NPWT) has been shown to improve wound care outcomes for acute and chronic wounds as well as for surgical incision sites. We have found that patients report significant pain during dressing changes specifically with the removal of the clear adhesive drape. Upon review of the literature, there were multiple studies related to pain and the removal of the sponge (filler) but limited studies relating to the pain associated with the removal of the drape. The patient reported pain with drape removal has led to increased psychological stress and decreased compliance with the dressing change protocol. Application of a topical anesthetic to the drape during the dressing change has the potential to decrease the pain experienced by the patient. An FDA approved ethyl chloride spray is a topical anesthetic that can be sprayed onto the outer perimeter of the drape during the dressing change as a means to decrease pain. We hypothesize that the use of ethyl chloride spray will result in patients experiencing less pain leading to decreased psychological stress, improved compliance with dressing changes, and overall improved customer satisfaction.

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 (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • an orthopaedic/trauma wound and/or surgical incision
  • treatment with NPWT as a hospital inpatient
  • minimum of at least one NPWT dressing changes or discontinuation of NPWT prior to discharge.
  • dressing change in enterostomal therapy department

排除标准

  • cognitive impairment preventing informed consent
  • history of hypersensitivity to cold/vapocoolant
  • outpatient NPWT

研究组 & 干预措施

Ethyl Chloride

Experimental

Ethyl Chloride topical anesthetic mist will be sprayed on the area of adhesive during dressing change for patients with negative pressure wound therapy

干预措施: Ethyl chloride (Drug)

Tissue culture grade water

Placebo Comparator

Tissue culture grade water (Nature's Tears Eyemist) will be sprayed on the area of adhesive during dressing change for patients with negative pressure wound therapy

干预措施: Tissue culture grade water (Other)

结局指标

主要结局

Patient-reported post procedure pain

时间窗: immediately after drape removal

Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.

Patient-reported during procedure pain

时间窗: during drape removal

Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable.

次要结局

  • Change in pain score from pre-procedure to post-procedure(immediately prior to drape change to immediately following drape change)
  • Change in pain score from pre-procedure to during procedure(immediately prior to drape change to during drape change)

研究者

发起方
ProMedica Health System
申办方类型
Other
责任方
Sponsor

研究点 (1)

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