BurnsEARLYNCT04880655

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

A study testing WSD and Dressed with bacitracin and petrolatum gauze in people with Burns and Partial-thickness Burn, run by University of Tennessee at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Burns, Partial-thickness Burn
What is being tested?: WSD and Dressed with bacitracin and petrolatum gauze
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 3 Aug 2021to 24 Oct 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Regional One Health
Memphis, Tennessee, 38103

Other trials in United States

About this study

Official title: 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:

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.

Read the 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.

Conditions: Burns, Partial-thickness Burn
Being tested: WSD, Dressed with bacitracin and petrolatum gauze
Keywords: EARLY, Randomized Clinical Trial, Surfactant, Dressing, Total Body Surface Area, Outcome Assessment, Thermal Burn Injuries
Medical subject headings: Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WSDDevice
Post debridement and within 24 hours of injury, wound care and WSD applied daily
Dressed with bacitracin and petrolatum gauzeDevice
Post debridement and within 24 hours of injury, wound care and dressing applied daily

Study groups in NCT04880655
Study group	Role	What they receive
Intervention	Experimental	Dressed with WSD and petrolatum gauze Receives: Device: WSD
Control	Active comparator	Dressed with bacitracin and petrolatum gauze Receives: Device: Dressed with bacitracin and petrolatum gauze

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent difference (cm2) in partial-thickness wound conversion
Tissue salvage
Measured: Up to 14 days

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 202124 Oct 2023

First posted11 May 2021
Study start3 Aug 2021
Primary completion24 Oct 2023
Study completion24 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for BurnsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04880655
Sponsor's protocol ID: 20-07861-XP
Acronym: EARLY
Status last verified: Oct 2023
First submitted: 3 May 2021
Last updated: 26 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 27428718
Birchenough SA, Rodeheaver GT, Morgan RF, Peirce SM, Katz AJ. Topical poloxamer-188 improves blood flow following thermal injury in rat mesenteric microvasculature. Ann Plast Surg. 2008 May;60(5):584-8. doi: 10.1097/SAP.0b013e3181651661.
PubMed 18434836
Rodeheaver GT, Kurtz L, Kircher BJ, Edlich RF. Pluronic F-68: a promising new skin wound cleanser. Ann Emerg Med. 1980 Nov;9(11):572-6. doi: 10.1016/s0196-0644(80)80228-9.
PubMed 7436067
Chen R, Salisbury AM, Percival SL. In vitro cellular viability studies on a concentrated surfactant-based wound dressing. Int Wound J. 2019 Jun;16(3):703-712. doi: 10.1111/iwj.13084. Epub 2019 Mar 20.
PubMed 30895731
Maskarinec SA, Wu G, Lee KY. Membrane sealing by polymers. Ann N Y Acad Sci. 2005 Dec;1066:310-20. doi: 10.1196/annals.1363.018.
PubMed 16533934
Lee RC, Hannig J, Matthews KL, Myerov A, Chen CT. Pharmaceutical therapies for sealing of permeabilized cell membranes in electrical injuries. Ann N Y Acad Sci. 1999 Oct 30;888:266-73. doi: 10.1111/j.1749-6632.1999.tb07961.x.
PubMed 10842638
Lee RC, River LP, Pan FS, Ji L, Wollmann RL. Surfactant-induced sealing of electropermeabilized skeletal muscle membranes in vivo. Proc Natl Acad Sci U S A. 1992 May 15;89(10):4524-8. doi: 10.1073/pnas.89.10.4524.
PubMed 1584787
Walsh AM, Mustafi D, Makinen MW, Lee RC. A surfactant copolymer facilitates functional recovery of heat-denatured lysozyme. Ann N Y Acad Sci. 2005 Dec;1066:321-7. doi: 10.1196/annals.1363.029.
PubMed 16533935
Greenebaum B, Blossfield K, Hannig J, Carrillo CS, Beckett MA, Weichselbaum RR, Lee RC. Poloxamer 188 prevents acute necrosis of adult skeletal muscle cells following high-dose irradiation. Burns. 2004 Sep;30(6):539-47. doi: 10.1016/j.burns.2004.02.009.
PubMed 15302418
Baskaran H, Toner M, Yarmush ML, Berthiaume F. Poloxamer-188 improves capillary blood flow and tissue viability in a cutaneous burn wound. J Surg Res. 2001 Nov;101(1):56-61. doi: 10.1006/jsre.2001.6262.
PubMed 11676555
Yang Q, Schultz GS, Gibson DJ. A Surfactant-Based Dressing to Treat and Prevent Acinetobacter baumannii Biofilms. J Burn Care Res. 2018 Aug 17;39(5):766-770. doi: 10.1093/jbcr/irx041.
PubMed 29931339
Yang Q, Larose C, Della Porta AC, Schultz GS, Gibson DJ. A surfactant-based wound dressing can reduce bacterial biofilms in a porcine skin explant model. Int Wound J. 2017 Apr;14(2):408-413. doi: 10.1111/iwj.12619. Epub 2016 May 22.
PubMed 27212453
Salisbury AM, Percival SL. Efficacy of a Surfactant-Based Wound Dressing in the Prevention of Biofilms. Adv Skin Wound Care. 2018 Nov;31(11):514-520. doi: 10.1097/01.ASW.0000544612.28804.34.
PubMed 30335643
Mayer D, Armstrong D, Schultz G, Percival S, Malone M, Romanelli M, Keast D, Jeffery S. Cell salvage in acute and chronic wounds: a potential treatment strategy. Experimental data and early clinical results. J Wound Care. 2018 Sep 2;27(9):594-605. doi: 10.12968/jowc.2018.27.9.594.
PubMed 30204575
Pittinger TP, Curran D, Hermans MH. The treatment of paediatric burns with concentrated surfactant gel technology: a case series. J Wound Care. 2020 Jun 1;29(Sup6):S12-S17. doi: 10.12968/jowc.2020.29.Sup6.S12.
PubMed 32530755

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Burns trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Study Evaluating a Surfactant-based Wound Dressing for Tissue Salvage and Reduction in Surgical Burden
ClinicalTrials.gov ID: NCT04880655
Acronym / sponsor ID: EARLY / 20-07861-XP
Conditions: Burns, Partial-thickness Burn
Keywords: EARLY, Randomized Clinical Trial, Surfactant, Dressing, Total Body Surface Area, Outcome Assessment, Thermal Burn Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of TennesseeUniversity, hospital or other
Collaborators: Medline Industries
Study start: 3 Aug 2021 (actual)
Primary completion: 24 Oct 2023 (actual)
Study completion: 24 Oct 2023 (actual)
First posted: 11 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Intervention	Experimental	Device: WSDDressed with WSD and petrolatum gauze
Control	Active comparator	Device: Dressed with bacitracin and petrolatum gauzeDressed with bacitracin and petrolatum gauze

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (7 listed)

chemical, electrical, or inhalation injury
pregnant
incarcerated
TBSA ≥ 20%
wound expected to heal within 7 days

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WSDPost debridement and within 24 hours of injury, wound care and WSD applied daily	Device	Intervention
Dressed with bacitracin and petrolatum gauzePost debridement and within 24 hours of injury, wound care and dressing applied daily	Device	Control

Primary outcome

Percent difference (cm2) in partial-thickness wound conversion
Time frame: Up to 14 days
Tissue salvage

4 secondary outcomes

Time to 95% re-epithelialization
Time frame: Up to 28 days
Daily pain scores for each wound care session
Time frame: Up to 7 days
Incidence of burn wound infection and cellulitis
Time frame: Up to 28 days
Hospital costs
Time frame: Up to 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Background: PubMed 27428718Palumbo 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.
Background: PubMed 18434836Birchenough SA, Rodeheaver GT, Morgan RF, Peirce SM, Katz AJ. Topical poloxamer-188 improves blood flow following thermal injury in rat mesenteric microvasculature. Ann Plast Surg. 2008 May;60(5):584-8. doi: 10.1097/SAP.0b013e3181651661.
Background: PubMed 7436067Rodeheaver GT, Kurtz L, Kircher BJ, Edlich RF. Pluronic F-68: a promising new skin wound cleanser. Ann Emerg Med. 1980 Nov;9(11):572-6. doi: 10.1016/s0196-0644(80)80228-9.
Background: PubMed 30895731Chen R, Salisbury AM, Percival SL. In vitro cellular viability studies on a concentrated surfactant-based wound dressing. Int Wound J. 2019 Jun;16(3):703-712. doi: 10.1111/iwj.13084. Epub 2019 Mar 20.
Background: PubMed 16533934Maskarinec SA, Wu G, Lee KY. Membrane sealing by polymers. Ann N Y Acad Sci. 2005 Dec;1066:310-20. doi: 10.1196/annals.1363.018.
Background: PubMed 10842638Lee RC, Hannig J, Matthews KL, Myerov A, Chen CT. Pharmaceutical therapies for sealing of permeabilized cell membranes in electrical injuries. Ann N Y Acad Sci. 1999 Oct 30;888:266-73. doi: 10.1111/j.1749-6632.1999.tb07961.x.
Background: PubMed 1584787Lee RC, River LP, Pan FS, Ji L, Wollmann RL. Surfactant-induced sealing of electropermeabilized skeletal muscle membranes in vivo. Proc Natl Acad Sci U S A. 1992 May 15;89(10):4524-8. doi: 10.1073/pnas.89.10.4524.
Background: PubMed 16533935Walsh AM, Mustafi D, Makinen MW, Lee RC. A surfactant copolymer facilitates functional recovery of heat-denatured lysozyme. Ann N Y Acad Sci. 2005 Dec;1066:321-7. doi: 10.1196/annals.1363.029.
Background: PubMed 15302418Greenebaum B, Blossfield K, Hannig J, Carrillo CS, Beckett MA, Weichselbaum RR, Lee RC. Poloxamer 188 prevents acute necrosis of adult skeletal muscle cells following high-dose irradiation. Burns. 2004 Sep;30(6):539-47. doi: 10.1016/j.burns.2004.02.009.
Background: PubMed 11676555Baskaran H, Toner M, Yarmush ML, Berthiaume F. Poloxamer-188 improves capillary blood flow and tissue viability in a cutaneous burn wound. J Surg Res. 2001 Nov;101(1):56-61. doi: 10.1006/jsre.2001.6262.
Background: PubMed 29931339Yang Q, Schultz GS, Gibson DJ. A Surfactant-Based Dressing to Treat and Prevent Acinetobacter baumannii Biofilms. J Burn Care Res. 2018 Aug 17;39(5):766-770. doi: 10.1093/jbcr/irx041.
Background: PubMed 27212453Yang Q, Larose C, Della Porta AC, Schultz GS, Gibson DJ. A surfactant-based wound dressing can reduce bacterial biofilms in a porcine skin explant model. Int Wound J. 2017 Apr;14(2):408-413. doi: 10.1111/iwj.12619. Epub 2016 May 22.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing WSD and Dressed with bacitracin and petrolatum gauze in people with Burns and Partial-thickness Burn, run by University of Tennessee at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent difference (cm2) in partial-thickness wound conversion (time frame: Up to 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04880655, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023; AzTrials last refreshed its copy on 30 Oct 2026.