To evaluate the efficacy of Granexin® gel to promote accelerated healing of second-degree (deep partial thickness) thermal burns.
Multi-center, prospective, randomized, double-blind, parallel-group, within-subject Vehicle controlled, safety and efficacy trial involving subjects with two comparable (similar body location, similar burn area and burn severity), noncontiguous deep second-degree thermal burns of less than 20% TBSA. A total of 30 subjects will have two target burns randomly assigned in a ratio of 1:1 to two treatment groups. * Granexin® gel (200 μM) plus ACTICOAT Flex 3TM * Vehicle gel plus ACTICOAT Flex 3TM The study procedures are divided into the following three periods: * Screening (within 36 hours of the time of injury) * Treatment (daily for 10 days) * Follow-up (Day 10 through Month 12) The anticipated total duration of a given subject's participation in this study is 12 months. Screening can occur up to 36 hours prior to Day 0; Screening and Day 0 may occur on the same day. Treatment period visits occur daily from Day 0 through Day 9, on-site and remotely. During the treatment period, each subject will be treated with Granexin® gel (200 μM) plus ACTICOAT Flex 3TM on one target burn and Vehicle gel plus ACTICOAT Flex 3TM on the second target burn. After Day 9, the subject will return to clinic on Day 10 and be followed-up (on-site or remotely) every other day thereafter until Day 28, with on-site visits on Days 14, 20, and 28. The subject will then return to the clinic for follow-up visits at Months 6, 9, and 12. Safety will be assessed during the study by monitoring adverse events and measuring vital signs at each on-site visit, electrocardiograms (ECG), and clinical laboratory tests at selected time points before and after treatment with Granexin® gel and Vehicle gel. Concomitant medications will be reviewed at every visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Granexin® gel (200 μM) will be topically applied once daily for 10 days in association with standard of care (SOC) wound cleaning and ACTICOAT Flex 3TM dressing.
Vehicle gel will be topically applied once daily for 10 days in association with standard of care (SOC) wound cleaning and ACTICOAT Flex 3TM dressing.
Time to re-epithelization
Time (in days) to 100% re-epitheliazation of deep second degree burns as determined through clinical assessments
Time frame: From Day 0 to Month 12
Reduction in scar severity at Month 12
Assessed using the Vancouver Scar Scale. The Vancouver Scar Scale has 4 variables: Vascularity, Height (thickness), Pliability, Pigmentation. Each variable has three to six possible scores. The scores for the four components will be added to obtain the total score. The total score ranges from 0 to 13, whereby a score of 0 reflects normal skin.
Time frame: Month 12
Proportion of burns that convert from partial thickness burns to full thickness burns
Burn conversion is determined through clinical assessment.
Time frame: From Day 0 to Day 28
Proportion of subjects needing additional burn interventions
Determined by the initiation of burn interventions, including surgery and skin grafts
Time frame: From Day 0 to Day 28
Time to skin grafting
Determined by time (in days) to skin grafting
Time frame: From Day 0 to Month 12
Incidence of infection
Determined by Investigator's assessment of presence or absence of infection
Time frame: From Day 0 to Month 12
Incidence of treatment related adverse events (AEs)
Assessed using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0. Events that are probably, possible, and definitely related will be considered treatment related events.
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Time frame: From Day 0 to Month 12