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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the following hypotheses: Early use of water-soluble surfactant dressing (WSD) on partial-thickness burn wounds will result in tissue salvage and reduce surgical burden. Early use of WSD on partial-thickness burn wounds will result in faster healing. Use of WSD on partial-thickness burn wounds will result in less painful wound care. Early use of WSD on partial-thickness burn wounds will result in less infection. 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.

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

Conditions
-----------------
Burns, Partial-thickness Burn

Intervention / Treatment
-----------------
* Device: WSD
* Device: Dressed with bacitracin and petrolatum gauze


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Dressed with WSD and petrolatum gauze | Device: WSD<br>* Post debridement and within 24 hours of injury, wound care and WSD applied daily<br>|
| Active Comparator: Control<br>Dressed with bacitracin and petrolatum gauze | Device: Dressed with bacitracin and petrolatum gauze<br>* Post debridement and within 24 hours of injury, wound care and dressing applied daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent difference (cm2) in partial-thickness wound conversion | Tissue salvage | Up to 14 days | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EARLY, Randomized Clinical Trial, Surfactant, Dressing, Total Body Surface Area, Outcome Assessment, Thermal Burn Injuries