Ethyl Chloride for NPWT

ProMedica Health System

Status and phase: Completed; Phase 4

Conditions: Pain, Acute

Treatments: Other: Tissue culture grade water; Drug: Ethyl chloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04635696

18-079

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups, including a placebo group

Ethyl Chloride

Experimental group

Description:

Ethyl Chloride topical anesthetic mist will be sprayed on the area of adhesive during dressing change for patients with negative pressure wound therapy

Treatment:

Drug: Ethyl chloride

Tissue culture grade water

Placebo Comparator group

Description:

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

Treatment:

Other: Tissue culture grade water