A Randomized Trial Evaluating EARLY Application of a Surf... | NCT04880655

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

NCT04880655

Sponsor

University of Tennessee

Status

Completed

Last Update Posted

Oct 26, 2023Actual

Enrollment

27Actual

Phase

Not Applicable

Conditions

Burns
Partial-thickness Burn

Interventions

WSD
Dressed with bacitracin and petrolatum gauze

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 3, 2021Actual

Primary Completion Date

Oct 24, 2023Actual

Completion Date

Oct 24, 2023Actual

First Submitted Date

May 3, 2021

First Submission Date that Met QC Criteria

May 8, 2021

First Posted Date

May 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2023

Last Update Posted Date

Oct 26, 2023Actual

Name	Class
Medline Industries	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Dressed with WSD and petrolatum gauze	Device: WSD
Control	Active Comparator	Dressed with bacitracin and petrolatum gauze	Device: Dressed with bacitracin and petrolatum gauze

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WSD	Device	Post debridement and within 24 hours of injury, wound care and WSD applied daily	Intervention

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Regional One Health		Memphis	Tennessee	38103	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27428718	Background	Palumbo FP, Harding KG, Abbritti F, Bradbury S, Cech JD, Ivins N, Klein D, Menzinger G, Meuleneire F, Seratoni S, Zolss C, Mayer D. New Surfactant-based Dressing Product to Improve Wound Closure Rates of Nonhealing Wounds: A European Multicenter Study Including 1036 Patients. Wounds. 2016 Jul;28(7):233-40.
18434836	Background