Pain, AcutePhase 4NCT04635696
Ethyl Chloride for NPWT
A Phase 4 study testing Ethyl chloride and Tissue culture grade water in people with Pain, Acute, run by ProMedica Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Ethyl chloride and Tissue culture grade water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2019to 10 Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cognitive impairment preventing informed consent
- history of hypersensitivity to cold/vapocoolant
- outpatient NPWT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy
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
- Being tested
- Ethyl chloride, Tissue culture grade water
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl chlorideDrug
Also called vapocoolant
Pressurized vapocoolant developed for acute, mild pain relief.
Tissue culture grade waterOther
Also called Nature's Tears Eyemist
Pressurized water mist
| Study group | Role | What they receive |
|---|---|---|
| Ethyl Chloride | Experimental | Ethyl Chloride topical anesthetic mist will be sprayed on the area of adhesive during dressing change for patients with negative pressure wound therapy Receives: Drug: Ethyl chloride |
| Tissue culture grade water | Placebo comparator | 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 Receives: Other: Tissue culture grade water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported post procedure pain
Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Measured: immediately after drape removal
Patient-reported during procedure pain
Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable.
Measured: during drape removal
Secondary outcomes (2)
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.
Measured: immediately prior to drape change to immediately following drape change
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.
Measured: immediately prior to drape change to during drape change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start7 Jan 2019
- Primary completion10 Dec 2020
- Study completion10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635696
- Sponsor's protocol ID
- 18-079
- Status last verified
- Mar 2021
- First submitted
- 13 Nov 2020
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33755640
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy
- ClinicalTrials.gov ID
- NCT04635696
- Acronym / sponsor ID
- 18-079
- Conditions
- Pain, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 10 Dec 2020 (actual)
- Study completion
- 10 Dec 2020 (actual)
- First posted
- 19 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ethyl Chloride | Experimental | Drug: Ethyl chlorideEthyl 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 | Placebo comparator | Other: Tissue culture grade waterTissue 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- cognitive impairment preventing informed consent
- history of hypersensitivity to cold/vapocoolant
- outpatient NPWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ethyl chlorideAlso: vapocoolantPressurized vapocoolant developed for acute, mild pain relief. | Drug | Ethyl Chloride |
| Tissue culture grade waterAlso: Nature's Tears EyemistPressurized water mist | Other | Tissue culture grade water |
Primary outcome
Patient-reported post procedure pain
Time frame: immediately after drape removal
Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Patient-reported during procedure pain
Time frame: during drape removal
Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable.
2 secondary outcomes
Change in pain score from pre-procedure to post-procedure
Time frame: immediately prior to drape change to immediately following drape change
Change in pain score from pre-procedure to during procedure
Time frame: immediately prior to drape change to during drape change
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
- Derived from this study: PubMed 33755640Tank 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pain, Acute
Recruiting
Postoperative Delirium and Analgesia in Elderly Patients
Postoperative Delirium, Postoperative Pain, Acute
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingPhase 1/2
Vasopressin and Pain Perception in the Brain
Acute Pain
Not yet recruitingPhase 2
Investigating the Analgesic Potential of (2R,6R)-HNK in Acute Pain in Healthy Volunteers
Healthy Volunteers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ethyl chloride and Tissue culture grade water in people with Pain, Acute, run by ProMedica Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported post procedure pain (time frame: immediately after drape removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04635696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.