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Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04084093
Recruitment Status : Withdrawn (Study will be redesigned.)
First Posted : September 10, 2019
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Medline Industries

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.

Condition or disease Intervention/treatment Phase
Burns Device: Surfactant Gel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients
Actual Study Start Date : February 12, 2020
Actual Primary Completion Date : April 8, 2020
Actual Study Completion Date : April 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

Arm Intervention/treatment
Experimental: Surfactant Gel Device: 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Measure percent change in epithelium as recorded by the clinician. [ Time Frame: Baseline to Day 30 ]
  2. Measure percent change in necrotic tissue in the wound bed [ Time Frame: Baseline to Day 30 ]
  3. Measure change in wound size [ Time Frame: Baseline to Day 30 ]
  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04084093


Locations
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United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70809
Sponsors and Collaborators
Medline Industries
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Responsible Party: Medline Industries
ClinicalTrials.gov Identifier: NCT04084093    
Other Study ID Numbers: MED-2018-DIV31-011
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Pulmonary Surfactants
Respiratory System Agents