Burns, Partial-thickness Burn
Conditions
Keywords
EARLY, Randomized Clinical Trial, Surfactant, Dressing, Total Body Surface Area, Outcome Assessment, Thermal Burn Injuries
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.
Interventions
DEVICEWSD
Post debridement and within 24 hours of injury, wound care and WSD applied daily
DEVICEDressed with bacitracin and petrolatum gauze
Post debridement and within 24 hours of injury, wound care and dressing applied daily
Sponsors
Medline Industries
University of Tennessee
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent difference (cm2) in partial-thickness wound conversion | Up to 14 days | Tissue salvage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to 95% re-epithelialization | Up to 28 days | Healing time |
| 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) |
| 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 |
Countries
United States
Outcome results
None listed