A novel, reverse-phase-shifting, thermoreversible foaming hydrogel containing antibiotics for the treatment of thermal burns in a swine model - A pilot study

Ross I Donaldson; Jonathan K Armstrong; Oliver J Buchanan; Todd L Graham; John S Cambridge; Nely N Cristerna; Diane Goldenberg; Captain David A Tanen; Timothy C Fisher; Juliana Tolles; Christopher J Burns; James D Ross

doi:10.1016/j.burns.2024.03.018

A novel, reverse-phase-shifting, thermoreversible foaming hydrogel containing antibiotics for the treatment of thermal burns in a swine model - A pilot study

Burns. 2024 Mar 15:S0305-4179(24)00090-1. doi: 10.1016/j.burns.2024.03.018. Online ahead of print.

Affiliations

¹ Critical Innovations LLC, 4228 Marine Avenue, Los Angeles, CA 90260, USA; Department of Emergency Medicine, David Geffen School of Medicine at UCLA, 10833 Le Conte Ave, Los Angeles, CA 90095, USA; Department of Emergency Medicine, Harbor-UCLA Medical Center, Box 21, 1000 West Carson Street, Torrance, CA 90509, USA; Department of Epidemiology, UCLA - Fielding School of Public Health, 650 Charles E Young Drive South, Los Angeles, CA 90095, USA. Electronic address: rdonaldson@criticalinnovations.com.
² Critical Innovations LLC, 4228 Marine Avenue, Los Angeles, CA 90260, USA.
³ Benchmark Biotech LLC, 1225 NE 2nd Ave, DCM 2nd Floor, Portland, OR 97232, USA.
⁴ Department of Emergency Medicine, David Geffen School of Medicine at UCLA, 10833 Le Conte Ave, Los Angeles, CA 90095, USA; Department of Emergency Medicine, Harbor-UCLA Medical Center, Box 21, 1000 West Carson Street, Torrance, CA 90509, USA.
⁵ Brigham and Women's Hospital, Division of Trauma, Burn and Surgical Critical Care, 45 Francis Street, Boston, MA 02115, USA.

PMID: 38582695
DOI: 10.1016/j.burns.2024.03.018

Abstract

Background: This study compared a novel topical hydrogel burn dressing (CI-PRJ012) to standard of care (silver sulfadiazine) and to untreated control in a swine thermal burn model, to assess for wound healing properties both in the presence and absence of concomitant bacterial inoculation.

Methods: Eight equal burn wounds were created on six Yorkshire swine. Half the wounds were randomized to post-burn bacterial inoculation. Wounds were subsequently randomized to three treatments groups: no intervention, CI-PRJ012, or silver sulfadiazine cream. At study end, a blinded pathologist evaluated wounds for necrosis and bacterial colonization.

Results: When comparing CI-PRJ012 and silver sulfadiazine cream to no treatment, both agents significantly reduced the amount of necrosis and bacteria at 7 days after wound creation (p < 0.01, independently for both). Further, CI-PRJ012 was found to be significantly better than silver sulfadiazine (p < 0.02) in reducing bacterial colonization. For wound necrosis, no significant difference was found between silver sulfadiazine cream and CI-PRJ012 (p = 0.33).

Conclusions: CI-PRJ012 decreases necrosis and bacterial colonization compared to no treatment in a swine model. CI-PRJ012 appeared to perform comparably to silver sulfadiazine. CI-PRJ012, which is easily removed with the application of room-temperature water, may provide clinical advantages over silver sulfadiazine.

Keywords: Hydrogel; Injury; Swine; Thermal; Thermoreversible.