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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethyl chloride | Drug | Pressurized vapocoolant developed for acute, mild pain relief. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported post procedure pain | Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable. | immediately after drape removal |
| Patient-reported during procedure pain | Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable. | during drape removal |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | immediately prior to drape change to immediately following drape change |
| Change in pain score from pre-procedure to during procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33755640 | Derived | 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. |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005018 | Ethyl Chloride |
| ID | Term |
|---|---|
| D006843 | Hydrocarbons, Chlorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Tissue culture grade water | Other | Pressurized water mist |
|
|
change in pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable. |
| immediately prior to drape change to during drape change |