Ethyl Chloride for NPWT

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Acute
• Intervention / Treatment: Drug: Ethyl chloride; Other: Tissue culture grade water

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Toledo, Ohio, United States, 43606
      • ProMedica Toledo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: Ethyl chloride; Pressurized vapocoolant developed for acute, mild pain relief.; Other Names: vapocoolant
PLACEBO_COMPARATOR: 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	Other: Tissue culture grade water; Pressurized water mist; Other Names: Nature's Tears Eyemist

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ProMedica Health System

Publications and helpful links

General Publications

• Tank JC, Georgiadis GM, Bair JM, Rice A, O'Mara Gardner K, Chen JT, Redfern RE. Does The Use of Ethyl Chloride Improve Patient-Reported Pain Scores With Negative Pressure Wound Therapy Dressing Changes? A Prospective, Randomized Controlled Trial. J Trauma Acute Care Surg. 2021 Jun 1;90(6):1061-1066. doi: 10.1097/TA.0000000000003157.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2019
• Primary Completion (ACTUAL): December 10, 2020
• Study Completion (ACTUAL): December 10, 2020

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (ACTUAL): November 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ethyl Chloride
• Other Study ID Numbers: 18-079

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No