Back to resultsEvaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Primary Purpose
Burns
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surfactant Gel
Sponsored by
About this trial
This is an interventional treatment trial for Burns
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.
Sites / Locations
- Loyola University Medical Center
- Baton Rouge General Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Surfactant Gel
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Measure percent change in epithelium as recorded by the clinician.
Measure percent change in necrotic tissue in the wound bed
Measure change in wound size
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04084093
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study will be redesigned.
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
April 8, 2020 (Actual)
Study Completion Date
April 8, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medline Industries
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Surfactant Gel
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Surfactant Gel
Intervention 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 Outcome Measure Information:
Title
Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale.
Description
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
Secondary Outcome Measure Information:
Title
Measure percent change in epithelium as recorded by the clinician.
Time Frame
Baseline to Day 30
Title
Measure percent change in necrotic tissue in the wound bed
Time Frame
Baseline to Day 30
Title
Measure change in wound size
Time Frame
Baseline to Day 30
Title
Measure anxiety using a burn specific anxiety scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
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