Ethyl Chloride for NPWT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-07

Study Completion Date

2020-12-10

Brief Summary

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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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Detailed Description

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Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ethyl Chloride

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

Group Type EXPERIMENTAL

Ethyl chloride

Intervention Type DRUG

Pressurized vapocoolant developed for acute, mild pain relief.

Tissue culture grade water

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

Group Type PLACEBO_COMPARATOR

Tissue culture grade water

Intervention Type OTHER

Pressurized water mist

Interventions

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Ethyl chloride

Pressurized vapocoolant developed for acute, mild pain relief.

Intervention Type DRUG

Tissue culture grade water

Pressurized water mist

Intervention Type OTHER

Other Intervention Names

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vapocoolant Nature's Tears Eyemist

Eligibility Criteria

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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