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

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.