ProMedica Toledo Hospital
Toledo, Ohio, 43606, United States
NCT Number: NCT04635696
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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Notify Me18 year–85 year
All sexes
Interventional
Phase 4
Toledo, Ohio, 43606, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pressurized vapocoolant developed for acute, mild pain relief.
Other names: vapocoolant
Pressurized water mist
Other names: Nature's Tears Eyemist
Time frame: immediately after drape removal
Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
Time frame: during drape removal
Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable.
Time frame: immediately prior to drape change to immediately following drape change
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
change in pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable.
ProMedica Health System
Other
Evaluating the Efficacy of Ethyl Chloride on Patients' Reported Pain With Negative Pressure Wound Therapy
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