NCT04635696

Ethyl Chloride for NPWT

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: ProMedica Health System · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Ethyl chloride	Pressurized vapocoolant developed for acute, mild pain relief.
OTHER	Tissue culture grade water	Pressurized water mist

Timeline

• Start date: 2019-01-07
• Primary completion: 2020-12-10
• Completion: 2020-12-10
• First posted: 2020-11-19
• Last updated: 2021-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study