Ethyl Chloride for NPWT

Pain, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04635696
• Other study ID #: 18-079
• Status: Completed
• Phase: Phase 4
• Start date: January 7, 2019
• Est. completion date: December 10, 2020

Study information

• Verified date: March 2021
• Source: ProMedica Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 10, 2020
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute

Intervention

Drug:
• Ethyl chloride
Pressurized vapocoolant developed for acute, mild pain relief.

Other:
• Tissue culture grade water
Pressurized water mist

Locations

Country	Name	City	State
United States	ProMedica Toledo Hospital	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
ProMedica Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-reported post procedure pain	Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.	immediately after drape removal
Primary	Patient-reported during procedure pain	Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable.	during drape removal
Secondary	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
Secondary	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