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OpenTrials
Completed

NCT Number: NCT04635696

Ethyl Chloride for NPWT

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Ethyl chloride

Drug

Pressurized vapocoolant developed for acute, mild pain relief.

Other names: vapocoolant

Tissue culture grade water

Other

Pressurized water mist

Other names: Nature's Tears Eyemist

Primary outcomes

  1. Patient-reported post procedure pain

    Time frame: immediately after drape removal

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

  2. Patient-reported during procedure pain

    Time frame: during drape removal

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

Secondary outcomes

  1. Change in pain score from pre-procedure to post-procedure

    Time frame: immediately prior to drape change to immediately following drape change

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

  2. Change in pain score from pre-procedure to during procedure

    Time frame: immediately prior to drape change to during drape change

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

Sponsors and collaborators

Lead sponsor

ProMedica Health System

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 19, 2020
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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