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

NCT04880655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-10-26

No results posted yet for this study

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.

Conditions

  • Burns
  • Partial-thickness Burn

Interventions

DEVICE

WSD

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

DEVICE

Dressed with bacitracin and petrolatum gauze

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

Sponsors & Collaborators

  • Medline Industries

    collaborator INDUSTRY

  • University of Tennessee

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-03
Primary Completion
2023-10-24
Completion
2023-10-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04880655 on ClinicalTrials.gov