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Completed

NCT Number: NCT04880655

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Regional One Health

Memphis, Tennessee, 38103, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WSD

Device

Post debridement and within 24 hours of injury, wound care and WSD applied daily

Dressed with bacitracin and petrolatum gauze

Device

Post debridement and within 24 hours of injury, wound care and dressing applied daily

Primary outcomes

  1. Percent difference (cm2) in partial-thickness wound conversion

    Time frame: Up to 14 days

    Tissue salvage

Secondary outcomes

  1. Time to 95% re-epithelialization

    Time frame: Up to 28 days

    Healing time

  2. Daily pain scores for each wound care session

    Time frame: Up to 7 days

    Pain via Numeric Rating Scale (0-10; 0 having no pain and 10 being the worst possible pain)

  3. Incidence of burn wound infection and cellulitis

    Time frame: Up to 28 days

    Infection up to day of initial excision or day of discharge

  4. Hospital costs

    Time frame: Up to 28 days

    Cost of care during inpatient stay

Sponsors and collaborators

Lead sponsor

University of Tennessee

Other

Collaborators

  • Medline Industries

Registry information

Official study title

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

Acronym: EARLY

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 11, 2021
Registry last updated
Oct 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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