Self-expanding foam for prehospital treatment of intra-abdominal hemorrhage: 28-day survival and safety

Adam P. Rago, Michael J. Duggan, John Beagle, Miroslav P. Peev, John Marini, John O. Hwabejire, Patricia Hannett, Greg Zugates, Rany Busold, Marc Helmick, George Velmahos, Marc A. Demoya, Daniel Dante Yeh, Peter J. Fagenholz, Upma Sharma, David R. King

Research output: Contribution to journalArticlepeer-review

22 Scopus citations

Abstract

BACKGROUND: Intracavitary noncompressible hemorrhage remains a significant cause of preventable death on the battlefield and in the homeland. We previously demonstrated the hemostatic efficacy of an in situ self-expanding poly(urea)urethane foam in a severe, closed-cavity, hepatoportal exsanguination model in swine. We hypothesized that treatment with, and subsequent explantation of, foam would not adversely impact 28-day survival in swine. METHODS: Following a closed-cavity splenic transection, animals received either fluid resuscitation alone (control group, n = 6) or resuscitation plus foam treatment at doses of 100 mL (n = 6), 120 mL (n = 6), and 150 mL (n = 2). Foam was allowed to polymerize in situ and was explanted after 3 hours. The animals were recovered and monitored for 28 days. RESULTS: All 18 animals in the 100-mL, 120-mL, and control groups survived to the 28-day endpoint without complications. The 150-mL group was terminated after the acute phase (n = 2). En bloc explantation of the foam took less than 2 minutes and was associated with millimeter-sized remnant particles. All foam animals required some level of enteric repair (imbrication or resection). Excluding the aborted 150-mL group, all animals survived, with no differences in renal or hepatic function, serum chemistries, or semiquantitative abdominal adhesion scores. Histologic analysis demonstrated that remnant particles were associated with a fibrotic capsule and mild inflammation, similar to that of standard suture reaction. In addition, safety testing (including genotoxicity, pyrogenicity, and cytotoxicity) was performed consistent with the ISO-10993 standard, and the materials passed all tests. CONCLUSION: For a distinct dose range, 28-day recovery after foam treatment and explantation for noncompressible, intra-abdominal hemorrhage is not associated with significant physiologic or biochemical evidence of end-organ dysfunction. A foam volume exceeding the maximum tolerable dose was identified. Bowel repair is required to ensure survival.

Original languageEnglish (US)
Pages (from-to)S127-S133
JournalJournal of Trauma and Acute Care Surgery
Volume77
Issue number3 SUPPL. 2
DOIs
StatePublished - 2014
Externally publishedYes

Keywords

  • abdominal hemorrhage
  • Noncompressible
  • safety
  • survival
  • swine

ASJC Scopus subject areas

  • Surgery
  • Critical Care and Intensive Care Medicine

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