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

Not Applicable

Completed

• Conditions: Partial-thickness Burn; Burns
• Interventions: Device: WSD; Device: Dressed with bacitracin and petrolatum gauze

• Registration Number: NCT04880655
• Lead Sponsor: University of Tennessee

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.

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-08
• Study First Posted: 2021-05-11
• Study Start: 2021-08-03
• Status Verified: 2023-10
• Primary Completion: 2023-10-24
• Study Completion: 2023-10-24
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	WSD	Dressed with WSD and petrolatum gauze
Control	Dressed with bacitracin and petrolatum gauze	Dressed with bacitracin and petrolatum gauze

Primary Outcome Measures

Name	Time	Method
Percent difference (cm2) in partial-thickness wound conversion	Up to 14 days	Tissue salvage

Secondary Outcome Measures

Name	Time	Method
Daily pain scores for each wound care session	Up to 7 days	Pain via Numeric Rating Scale (0-10; 0 having no pain and 10 being the worst possible pain)
Time to 95% re-epithelialization	Up to 28 days	Healing time
Incidence of burn wound infection and cellulitis	Up to 28 days	Infection up to day of initial excision or day of discharge
Hospital costs	Up to 28 days	Cost of care during inpatient stay

Trial Locations

Locations (1)

Regional One Health; 🇺🇸 Memphis, Tennessee, United States