This will be an observational study evaluating subject's perception of pain to dressing changes during removal and application of a surfactant gel. Wound healing will also be monitored. Anxiety before dressing change will be measured using a burn specific pain anxiety scale. Study intervention will include cleansing the wound per the facility's standard of care, followed by applying the investigational product on the wound. This will be followed by placing an appropriate secondary dressing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
This device is helps in the creation of an optimal moist wound healing environment that aids in protecting healthy tissues and provides an environment conductive to autolytic debridement. The device is 100% water-soluble, biocompatible, and non-ionic. The dressing is a surfactant based gel.
Loyola University Medical Center
Maywood, Illinois, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States
Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale.
The numerical pain scale will be from 0 to 10 with 0 being no pain at all and 10 being the worst pain ever possible. This is the numeric rating scale.
Time frame: Baseline to Day 30
Measure percent change in epithelium as recorded by the clinician.
Time frame: Baseline to Day 30
Measure percent change in necrotic tissue in the wound bed
Time frame: Baseline to Day 30
Measure change in wound size
Time frame: Baseline to Day 30
Measure anxiety using a burn specific anxiety scale
A burn-specific pain anxiety scale will be used to measure level of anxiety. Items will be scored on a 100mm visual analog line with two reference points, 0 and 100. These reference points will also be identified by expressions "not at all" and "the worst imaginable way". Subjects will be requested to scale the strength of their feelings relative to two reference points.
Time frame: Baseline to Day 30
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.