Pain, Acute
Conditions
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.
Interventions
DRUGEthyl chloride
Pressurized vapocoolant developed for acute, mild pain relief.
OTHERTissue culture grade water
Pressurized water mist
Sponsors
ProMedica Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-reported post procedure pain | immediately after drape removal | Pain reported on 0-10 numeric pain scale (NPS), where lower reported scores are favorable. |
| Patient-reported during procedure pain | during drape removal | Pain reported on 1-10 numeric pain scale (NPS), where lower reported scores are favorable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain score from pre-procedure to post-procedure | 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. |
| Change in pain score from pre-procedure to during procedure | 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. |
Countries
United States
Outcome results
None listed