NCT04880655

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

A Randomized, Controlled Study Evaluating a Surfactant-based Wound Dressing for Tissue Salvage and Reduction in Surgical Burden

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Tennessee · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Burns
• Partial-thickness Burn

Interventions

Type	Name	Description
DEVICE	WSD	Post debridement and within 24 hours of injury, wound care and WSD applied daily
DEVICE	Dressed with bacitracin and petrolatum gauze	Post debridement and within 24 hours of injury, wound care and dressing applied daily

Timeline

• Start date: 2021-08-03
• Primary completion: 2023-10-24
• Completion: 2023-10-24
• First posted: 2021-05-11
• Last updated: 2023-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study