Ethyl Chloride for NPWT

Study Overview
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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.

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

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: Ethyl chloride
* Other: Tissue culture grade water


Participation Criteria
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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 Exclusion Criteria: cognitive impairment preventing informed consent history of hypersensitivity to cold/vapocoolant outpatient NPWT

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ethyl Chloride<br>Ethyl Chloride topical anesthetic mist will be sprayed on the area of adhesive during dressing change for patients with negative pressure wound therapy | Drug: Ethyl chloride<br>* Pressurized vapocoolant developed for acute, mild pain relief.<br>* Other names: vapocoolant;|
| Placebo Comparator: Tissue culture grade water<br>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 | Other: Tissue culture grade water<br>* Pressurized water mist<br>* Other names: Nature's Tears Eyemist;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported post procedure pain | Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable. | immediately after drape removal | 
| Patient-reported during procedure pain | Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable. | during drape removal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain score from pre-procedure to post-procedure | change in pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable. | immediately prior to drape change to immediately following drape change | 
| Change in pain score from pre-procedure to during procedure | change in pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable. | immediately prior to drape change to during drape change |