Clinical trial NCT04084093: Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Official title: Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2019-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Subject should be an inpatient, per the Two-Midnight rule at the time of study initiation.
* At the time of subject's admission in the hospital, duration of his or her burn wound should be \< or equal to 24 hours.
* Subject who has a partial thickness burn wound, or an indeterminate burn wound, or who has both these characteristics in the same wound, as determined by the site Principal Investigator.
* Subject's wound included in this study, does not require any surgical intervention.
* Subject is able and willing to comply with requirements of this trial protocol.
* Voluntarily signed informed consent obtained before any trial-related procedures are performed.
* Subject must be able to communicate effectively with study personnel.
* Subject has burn total body surface area (TBSA) between 1-20%.

Exclusion Criteria:

* Subjects with electrical or radiation burns.
* Subjects who are pregnant, nursing or planning to become pregnant during the course of the study.
* Subjects who have known allergies to any ingredients in the dressings used in the study.
* Subjects taking opiates during the study duration.
* Subjects with an active diagnosis of substance use disorder within the past six months.
* Subjects with previously diagnosed issues with pain perception, including conditions such as peripheral neuropathy, if they will preclude accurate assessment of primary and secondary endpoints.
* Subjects with an active infection prior to enrollment.
* Subject has previous or current systemic disease(s) which, in the judgement of the investigator, is likely to interfere with treatment. Subjects with well-controlled diabetes mellitus (HbA1C\<8.5) shall be permitted.

Primary outcomes:
measure: Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale.
timeFrame: Baseline to Day 30
Secondary outcomes:
measure: Measure percent change in epithelium as recorded by the clinician.
timeFrame: Baseline to Day 30
measure: Measure percent change in necrotic tissue in the wound bed
timeFrame: Baseline to Day 30
measure: Measure change in wound size
timeFrame: Baseline to Day 30
measure: Measure anxiety using a burn specific anxiety scale
timeFrame: Baseline to Day 30
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Baton Rouge
country: United States
facility: Baton Rouge General Medical Center
state: Louisiana
Study officials:
References: