Evaluating the Use of a Concentrated Surfactant Gel in Burn Patients

NCT04084093 | Withdrawn FDA Device

• 1 other identifier: MED-2018-DIV31-011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Burns

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to Day 30

Secondary Outcomes (4)

• Measure percent change in epithelium as recorded by the clinician.

  Baseline to Day 30

• Measure percent change in necrotic tissue in the wound bed

  Baseline to Day 30

• Measure change in wound size

  Baseline to Day 30

• Measure anxiety using a burn specific anxiety scale

  Baseline to Day 30

Study Arms (1)

Surfactant Gel

EXPERIMENTAL

Device: Surfactant Gel

Interventions

Surfactant Gel DEVICE

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.

Surfactant Gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (2)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70809, United States

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: February 12, 2020
• Primary Completion: April 8, 2020
• Study Completion: April 8, 2020
• Last Updated: April 20, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)