search
Back to results

Ethyl Chloride for NPWT

Primary Purpose

Pain, Acute

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ethyl chloride
Tissue culture grade water
Sponsored by
ProMedica Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • ProMedica Toledo Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ethyl Chloride

Tissue culture grade water

Arm Description

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

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

Outcomes

Primary Outcome Measures

Patient-reported post procedure pain
Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Patient-reported during procedure pain
Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 13, 2020
Last Updated
March 9, 2021
Sponsor
ProMedica Health System
search

1. Study Identification

Unique Protocol Identification Number
NCT04635696
Brief Title
Ethyl Chloride for NPWT
Official Title
Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
December 10, 2020 (Actual)
Study Completion Date
December 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ProMedica Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ethyl Chloride
Arm Type
Experimental
Arm Description
Ethyl Chloride topical anesthetic mist will be sprayed on the area of adhesive during dressing change for patients with negative pressure wound therapy
Arm Title
Tissue culture grade water
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Ethyl chloride
Other Intervention Name(s)
vapocoolant
Intervention Description
Pressurized vapocoolant developed for acute, mild pain relief.
Intervention Type
Other
Intervention Name(s)
Tissue culture grade water
Other Intervention Name(s)
Nature's Tears Eyemist
Intervention Description
Pressurized water mist
Primary Outcome Measure Information:
Title
Patient-reported post procedure pain
Description
Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Time Frame
immediately after drape removal
Title
Patient-reported during procedure pain
Description
Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable.
Time Frame
during drape removal
Secondary Outcome Measure Information:
Title
Change in pain score from pre-procedure to post-procedure
Description
change in pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Time Frame
immediately prior to drape change to immediately following drape change
Title
Change in pain score from pre-procedure to during procedure
Description
change in pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Time Frame
immediately prior to drape change to during drape change

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33755640
Citation
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.
Results Reference
derived

Learn more about this trial

Ethyl Chloride for NPWT

We'll reach out to this number within 24 hrs