Clinical trial NCT04880655: A Randomized Trial Evaluating EARLY Application of a Surfactant Dressing in Thermal Injury (EARLY)
Official title: A Randomized, Controlled Study Evaluating a Surfactant-based Wound Dressing for Tissue Salvage and Reduction in Surgical Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Partial-thickness Burn
Keywords: EARLY
Randomized Clinical Trial
Surfactant
Dressing
Total Body Surface Area
Outcome Assessment
Thermal Burn Injuries
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Medline Industries
First posted: 2021-05-11
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the following hypotheses:

1. Early use of water-soluble surfactant dressing (WSD) on partial-thickness burn wounds will result in tissue salvage and reduce surgical burden.
2. Early use of WSD on partial-thickness burn wounds will result in faster healing.
3. Use of WSD on partial-thickness burn wounds will result in less painful wound care.
4. Early use of WSD on partial-thickness burn wounds will result in less infection.
5. Early use of WSD on partial-thickness burn wounds will result in lower hospital costs.

Detailed description: Surfactant-based wound dressings have been utilized in chronic, non-healing wounds and small burn wounds to soften and aid removal of wound debris. In vitro data suggest enhanced healing properties are due the ability to stabilize and potentially reseal plasma membranes, thereby, retaining cellular integrity and enhance wound healing. Improved cellular viability and functionality has also been established in heat-shock, ionizing radiation, and electrical injury models. In one rat model, topically suffused mesentery demonstrated improved microvascular flow and reduction in the number of abnormally flowing microvessels following thermal injury. Intravenous administration has been studied in several disease states. In thermal injury, intravenous administration has shown potential to improve blood flow and reduce the zone of coagulation. Further, surfactant-based wound dressings are non-ionic and may facilitate removal, sensitize, or prevent bacterial biofilms. Biofilms are an evolved, protective mechanism bacteria utilize to reduce antimicrobial efficacy. Removal or penetration of biofilms is essential for bacterial eradication. There is little evidence demonstrating the efficacy of early use of a WSD for treating partial-thickness burn wounds.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years old
* admitted within 24 hours of injury
* partial-thickness burn wounds on at least two non-contiguous areas of \< 10% TBSA each and not involving face, fingers, toes, and perineum
* initial management assessed to require inpatient care

Exclusion Criteria:

* chemical, electrical, or inhalation injury
* pregnant
* incarcerated
* TBSA ≥ 20%
* wound expected to heal within 7 days
* patient or authorized representative unable or unwilling to consent
* unable to consent within 24 hours of injury

Primary outcomes:
measure: Percent difference (cm2) in partial-thickness wound conversion
timeFrame: Up to 14 days
Secondary outcomes:
measure: Time to 95% re-epithelialization
timeFrame: Up to 28 days
measure: Daily pain scores for each wound care session
timeFrame: Up to 7 days
measure: Incidence of burn wound infection and cellulitis
timeFrame: Up to 28 days
measure: Hospital costs
timeFrame: Up to 28 days
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Regional One Health
state: Tennessee
Study officials:
References:
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