Current Clinical Trials
Fluorescence-based Detection of Inflammation and Necrosis to Inform Surgical Decision-making and Enhance Outcomes
ClinicalTrials.gov Identifier: NCT05593523
This study investigates fluorescence image-guided surgery to allow precise identification of necrotic tissue both pre- and intra-operatively in burn patients. Furthermore, it uses a multi-model approach to elucidate the localization of ICG in inflammation and necrosis to determine how this novel use of a well-known fluorescence marker can be optimized to aid in surgical decision-making. This study will provide the necessary data to support the design of a larger clinical trial to study the feasibility and efficacy of this technology to improve the precision of necrosis detection and removal, and to improve wound healing outcomes. Up to 100 participants will be in the study for up to approximately 24 days.
CP-003 Novosorb: A Pivotal Study to Assess the Safety and Effectiveness of NovoSorb Biodegradable Temporizing Matrix (BTM) in the Treatment of Severe Burn Skin Injuries
ClinicalTrials.gov Identifier: NCT04090424
This is a multicenter, randomized, adaptive design study to compare the safety and effectiveness of NovoSorb® BTM to the standard-of-care in patients with severe burn injuries.
The Acute Burn ResUscitation Multicenter Prospective Trial 2 (ABRUPT 2)
ClinicalTrials.gov Identifier: NCT04356859
This is a multicenter, prospective study that randomizes adults within 12 hours of a major burn injury to receive fluid resuscitation with either Lactated Ringers (LR) and 5% human albumin solution (colloid group) or LR alone (crystalloid group). The two groups will be compared during the first 48 hours of acute burn shock resuscitation.
Completed Multicenter Clinical Trials
An Adaptive, Randomized, Controlled Trial Evaluating the Effectiveness of PermeaDerm® as Compared to Mepilex Ag® Used as Standard of Care in the Treatment of Adult and Pediatric Partial Thickness Burns ClinicalTrials.gov Identifier: NCT05084183
This is a multisite, randomized, single-blinded clinical trial comparing the efficacy of PermeaDerm® (PD) to MepilexAg® in promoting complete (100%) epithelialization in partial thickness burns.
A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects with Deep Partial Thickness (DPT) Thermal Burns
ClinicalTrials.gov Identifier: NCT03005106
PMID: 34099322
This study evaluated whether StrataGraft® treatment promotes wound closure and reduces or eliminates the need for donor site harvest and autografting in a pediatric population with thermal burns that contain intact dermal elements and for which autografting would be part of the standard-of-care (deep partial-thickness burns).
The Acute Burn Resuscitation Multicenter Prospective Observational Trial (ABRUPT) ClinicalTrials.gov Identifier: NCT03144427
PMID: 34417368
This was a prospective, non-interventional, observational study of consecutive burn patients admitted to 20 selected burn centers in North America. Data collection was primarily continuous “real-time” documentation of fluid infusion rates, vital signs, and laboratory values of patients receiving fluid resuscitation during the first 48 hours following burn injury. The ABRUPT study findings will be used to design a definitive prospective randomized trial to evaluate crystalloids versus colloids during burn shock resuscitation.
StrataGraft Skin Tissue Expanded Access at Specific Study Sites (StrataCAT)
ClinicalTrials.gov Identifier: NCT04123548
This was an 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 that contain intact dermal elements and for which excision and autografts are clinically indicated. The goal of this proposal was to perform late-stage development activities to support the approval and licensure of StrataGraft® tissue.
Open-label, controlled, randomized, multicenter dose escalation study evaluating the safety, tolerability, and efficacy of single or multiple applications of StrataGraft® skin tissue as an alternative to autografting full-thickness complex skin defects.
ClinicalTrials.gov Identifier: NCT03005054
The goal of this proposal was to determine whether single or repeated application of StrataGraft® skin substitute can promote tissue regeneration in areas of full-thickness skin loss.