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

NCT04880655 | Completed FDA Device

• 1 other identifier: 20-07861-XP
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the following hypotheses:

1. 1.Early use of water-soluble surfactant dressing (WSD) on partial-thickness burn wounds will result in tissue salvage and reduce surgical burden.
2. 2.Early use of WSD on partial-thickness burn wounds will result in faster healing.
3. 3.Use of WSD on partial-thickness burn wounds will result in less painful wound care.
4. 4.Early use of WSD on partial-thickness burn wounds will result in less infection.
5. 5.Early use of WSD on partial-thickness burn wounds will result in lower hospital costs.

Conditions

Burns; Partial-thickness Burn

Keywords

EARLY; Randomized Clinical Trial; Surfactant; Dressing; Total Body Surface Area; Outcome Assessment; Thermal Burn Injuries

Outcome Measures

Primary Outcomes (1)

• Percent difference (cm2) in partial-thickness wound conversion

  Tissue salvage

  Up to 14 days

Secondary Outcomes (4)

• Time to 95% re-epithelialization

  Up to 28 days

• Daily pain scores for each wound care session

  Up to 7 days

• Incidence of burn wound infection and cellulitis

  Up to 28 days

• Hospital costs

  Up to 28 days

Study Arms (2)

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

WSD DEVICE

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

Intervention

Dressed with bacitracin and petrolatum gauze DEVICE

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead
• Medline Industries: collaborator

Study Sites (1)

Regional One Health

Memphis, Tennessee, 38103, United States

Location

Related Publications (17)

• 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.

  PMID: 27428718 BACKGROUND

• 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.

  PMID: 18434836 BACKGROUND

• 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.

  PMID: 7436067 BACKGROUND

• 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.

  PMID: 30895731 BACKGROUND

• 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.

  PMID: 16533934 BACKGROUND

• 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.

  PMID: 10842638 BACKGROUND

• 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.

  PMID: 1584787 BACKGROUND

• 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.

  PMID: 16533935 BACKGROUND

• 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.

  PMID: 15302418 BACKGROUND

• 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.

  PMID: 11676555 BACKGROUND

• 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.

  PMID: 29931339 BACKGROUND

• 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.

  PMID: 27212453 BACKGROUND

• 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.

  PMID: 30335643 BACKGROUND

• 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.

  PMID: 30204575 BACKGROUND

• 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.

  PMID: 32530755 BACKGROUND

• Pittinger T, Curran D, Hermans M. Treatment of Burns in Adult Patients With a Concentrated Surfactant Gel: A Real-life Retrospective Evaluation. Wounds. 2020 Dec;32(12):339-344.

  PMID: 33472159 BACKGROUND

• Kirsner RS, Amaya R, Bass K, Boyar V, Ciprandi G, Glat PM, Percival SL, Romanelli M, Pittinger TP. Effects of a surfactant-based gel on acute and chronic paediatric wounds: a panel discussion and case series. J Wound Care. 2019 Jun 2;28(6):398-408. doi: 10.12968/jowc.2019.28.6.398.

  PMID: 31166855 BACKGROUND

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 11, 2021
• Study Start: August 3, 2021
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)