Ethyl Chloride for NPWT

Phase 4

Completed

• Conditions: Pain, Acute
• Interventions: Other: Tissue culture grade water; Drug: Ethyl chloride

• Registration Number: NCT04635696
• Lead Sponsor: ProMedica Health System

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-13
• Study First Posted: 2020-11-19
• Primary Completion: 2020-12-10
• Study Completion: 2020-12-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tissue culture grade water	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
Ethyl Chloride	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

ProMedica Toledo Hospital; 🇺🇸 Toledo, Ohio, United States