BurnsNCT04084093
Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
A study testing Surfactant Gel in people with Burns, run by Medline Industries at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Surfactant Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Feb 2020to 8 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70809
Loyola University Medical Center
Maywood, Illinois, 60153
About this study
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.
- Conditions
- Burns
- Being tested
- Surfactant Gel
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant GelDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Surfactant Gel | Experimental | Not described Receives: Device: Surfactant Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 30
Secondary outcomes (4)
Measure percent change in epithelium as recorded by the clinician.
Measured: Baseline to Day 30
Measure percent change in necrotic tissue in the wound bed
Measured: Baseline to Day 30
Measure change in wound size
Measured: 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.
Measured: Baseline to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start12 Feb 2020
- Primary completion8 Apr 2020
- Study completion8 Apr 2020
Why it stopped: Study will be redesigned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medline Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084093
- Sponsor's protocol ID
- MED-2018-DIV31-011
- Status last verified
- Sep 2019
- First submitted
- 6 Sep 2019
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
- ClinicalTrials.gov ID
- NCT04084093
- Acronym / sponsor ID
- MED-2018-DIV31-011
- Conditions
- Burns
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study will be redesigned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medline IndustriesIndustry (pharma, biotech, devices)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 8 Apr 2020 (actual)
- Study completion
- 8 Apr 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surfactant Gel | Experimental | Device: Surfactant Gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surfactant GelThis 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. | Device | Surfactant Gel |
Primary outcome
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.
4 secondary outcomes
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
Time frame: Baseline to Day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surfactant Gel in people with Burns, run by Medline Industries at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported evaluation of subject pain perception during dressing changes using a numerical pain scale. (time frame: Baseline to Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.