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

October 24, 2023 updated by: University of Tennessee

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: David M. Hill, PharmD

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38103
        • Regional One Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to 95% re-epithelialization
Time Frame: Up to 28 days
Healing time
Up to 28 days
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)
Up to 7 days
Incidence of burn wound infection and cellulitis
Time Frame: Up to 28 days
Infection up to day of initial excision or day of discharge
Up to 28 days
Hospital costs
Time Frame: Up to 28 days
Cost of care during inpatient stay
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Collaborators

Medline Industries

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2021

Primary Completion (Actual)

October 24, 2023

Study Completion (Actual)

October 24, 2023

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 8, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-07861-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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