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NCT04635696 · ClinicalTrials.gov registry record · Phase 4
Ethyl Chloride for NPWT
A Phase 4 study, sponsored by ProMedica Health System.
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT04635696: Completed Phase 4 study, sponsored by ProMedica Health System.
NCT04635696 is a Phase 4 study that has completed, run by ProMedica Health System. The registered enrollment target is 100 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04635696, a Phase 4 study, has completed, sponsored by ProMedica Health System.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study 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.
Primary Outcome
Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Interventions
- DRUG Ethyl chloride
- OTHER Tissue culture grade water
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2019-01-07 |
| Est. Completion | 2020-12-10 |
| Phase | Phase 4 |
What the finished NCT04635696 record still lists
NCT04635696 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 2 interventions - of which Ethyl chloride is the first listed.
NCT04635696 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04635696 about?
NCT04635696 is a clinical study titled "Ethyl Chloride for NPWT". 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...
What is the current status of trial NCT04635696?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2019-01-07. Estimated completion is 2020-12-10.
What interventions are being tested in trial NCT04635696?
The interventions under investigation include: Ethyl chloride (DRUG), Tissue culture grade water (OTHER).
Who is sponsoring clinical trial NCT04635696?
This trial is sponsored by ProMedica Health System, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04635696's enrollment target sits among peer trials
100 770th of 2000 higher than 1,148 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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