- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084093
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
April 16, 2020 updated by: Medline Industries
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 Overview
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
-
Maywood, Illinois, United States, 60153
- Loyola University Medical Center
-
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Baton Rouge General Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Surfactant Gel
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale.
Time Frame: Baseline to Day 30
|
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.
|
Baseline to Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure percent change in epithelium as recorded by the clinician.
Time Frame: Baseline to Day 30
|
Baseline to Day 30
|
|
Measure percent change in necrotic tissue in the wound bed
Time Frame: Baseline to Day 30
|
Baseline to Day 30
|
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Measure change in wound size
Time Frame: Baseline to Day 30
|
Baseline to Day 30
|
|
Measure anxiety using a burn specific anxiety scale
Time Frame: Baseline to Day 30
|
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.
|
Baseline to Day 30
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 12, 2020
Primary Completion (Actual)
April 8, 2020
Study Completion (Actual)
April 8, 2020
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
September 9, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MED-2018-DIV31-011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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