A Randomized Trial Evaluating EARLY Application of a Surfactant Dressing in Thermal Injury (EARLY)

University of Tennessee

Status: Completed

Conditions: Burns; Partial-thickness Burn

Treatments: Device: Dressed with bacitracin and petrolatum gauze; Device: WSD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04880655

20-07861-XP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups

Intervention

Experimental group

Description:

Dressed with WSD and petrolatum gauze

Treatment:

Device: WSD

Control

Active Comparator group

Description:

Dressed with bacitracin and petrolatum gauze

Treatment:

Device: Dressed with bacitracin and petrolatum gauze