Status:
WITHDRAWN
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Lead Sponsor:
Medline Industries
Conditions:
Burns
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04084093
Start Date
February 12 2020
End Date
April 8 2020
Last Update
April 20 2020
Active Locations (2)
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1
Loyola University Medical Center
Maywood, Illinois, United States, 60153
2
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70809