Acute Care Surgery

StrataGraft® Skin Tissue in the Promotion of Autologous Skin Regeneration of Complex Skin Defects Due to Thermal Burns That Contain Intact Dermal Elements

Principal Investigator: Joshua Carson, MD

Study Description: The proposed registration study is designed as a phase III open-label, controlled, randomized, multicenter study evaluating the efficacy and safety of StrataGraft skin tissue in promoting autologous skin tissue regeneration of complex skin defects due to thermal burns. The proposed study will include patients with 3-49% total body surface area (TBSA) complex skin defects due to thermal burns with intact dermal elements for which excision and autografting are clinically indicated. The study has been designed to focus on the evaluation of efficacy and safety of StrataGraft skin tissue, while also assessing the potential for StrataGraft skin tissue to promote healing of complex skin defects due to thermal burns as an alternative to donor site harvesting and autografting. Targeted enrollment for this study is up to 70 subjects with complex skin defects caused by thermal burns that containing intact dermal elements and for which surgical excision and autografts are clinically indicated.


Evaluating a point of care, quantitative matrix metalloproteinase assay as a predictor of successful graft take inpatients undergoing cutaneous autografting for acute burn injury

Principal Investigator: Joshua Carson, MD

Study Description: This is an observational pilot study of patients treated at UF Health Shands Burn Center adult service. This is a study to determine the predictive value of quantifying concentrations of specific MMPs. Coupling this with a specialized collection sample collection system and a calibrated fluorimetry allows for the rapid assessment of MMP concentrations. This assay has been validated as a predictor of failed wound healing in a published clinical study involving chronic open wounds.


Protective effects of propranolol in adults following major burn injury: a safety and efficacy trial

Principal Investigator: David Mozingo, MD

Study Description: This efficacy and safety trial will examine the effects and safety of propranolol administered to adult patients with severe burn injury. The investigators hypothesize that propranolol will provide significant benefit to adults following severe burn injury at doses that are safe and do not increase risk of adverse infectious and non-infectious outcomes.


The RE-ENERGIZE Study: RandomizEd Trial of ENtERal Glutamine to minimIZE Thermal Injury (RE-ENERGIZE)

Principal Investigator: David Mozingo, MD

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

  • Enteral glutamine administration decreases in-hospital mortality in adult patients with severe thermal burn injuries.
  • Enteral glutamine administration decreases hospital-acquired blood stream infections from Gram negative organisms and length of stay in ICU and hospital for adult patients with severe thermal burn injuries.
  • Enteral glutamine administration will improve the physical function of surviving burn injured patients and reduce their cost of care.

The objectives of this trial are to determine the overall treatment effect and safety of glutamine in burn patients. Specifically, the investigators want to assess the following outcomes in a sample of 2,700 patients in 80 sites:

  • In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on 6 month mortality?
  • In patients with severe, life-threatening burn injury, what is the effect of enteral glutamine on time to discharge alive from hospital, hospital-acquired blood stream infections from Gram negative organisms, hospital mortality, duration of stay in ICU and hospital, health-related quality of life, and health care resources?

Study to Evaluate the Efficacy and Safety of NexoBrid in Subjects With Thermal Burns

Principal Investigator: David Mozingo, MD

Study Description: This study will be a three-arms study intending to demonstrate superiority of NexoBrid treatment over the Gel Vehicle placebo control treatment and over SOC in thermal burn subjects. The study objectives are:

  • To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing complete eschar removal as compared with Gel vehicle,
  • To demonstrate the efficacy of enzymatic eschar removal with NexoBrid by providing earlier complete eschar removal, reduction in patients’ surgical burden and its related blood loss as compared to SOC,
  • To assess the safety of NexoBrid compared to SOC, including demonstration that treatment with NexoBrid does not cause an unacceptable level of harm on wound closure outcome and long-term outcomes of cosmesis and function. 

Please contact Tera Thigpin at 352.273.5670 or tera.thigpin@surgery.ufl.edu for more information about acute care surgery clinical trials.