Ethyl Chloride for NPWT

NCT04635696 | Completed Phase 4 FDA Drug

• 1 other identifier: 18-079
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Acute

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

Drug: Ethyl chloride

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

Other: Tissue culture grade water

Interventions

Ethyl chloride DRUG

Pressurized vapocoolant developed for acute, mild pain relief.

Also known as: vapocoolant

Ethyl Chloride

Tissue culture grade water OTHER

Pressurized water mist

Also known as: Nature's Tears Eyemist

Tissue culture grade water

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• ProMedica Health System: lead

Study Sites (1)

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Related Publications (1)

• 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.

  PMID: 33755640 DERIVED

MeSH Terms

Conditions

Acute Pain

Interventions

Ethyl Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: November 19, 2020
• Study Start: January 7, 2019
• Primary Completion: December 10, 2020
• Study Completion: December 10, 2020
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

US (1)