This study illustrates that although primary cardiac tumors in infants and children have a wide and unusual spectrum of clinical presentation, an individualized approach to tumor resection allows restoration of an adequate hemodynamic function and satisfactory long-term, tumor-free outcome.
NexoBrid (NXB) has been proven to be an effective selective enzymatic debridement agent in adults. This manuscript presents the combined clinical trial experience with NXB in children. Hundred and ten children aged 0.5 to 18 years suffering from deep thermal burns of up to 67% total body surface area were treated with NXB in three clinical trials. Seventy‐seven children were treated with NXB in a phase I/II study, where 92.7% of the areas treated achieved complete eschar removal within 0.9 days from admission. Thirty‐three children (17 NXB, 16 standard of care [SOC]) participated in a phase III randomized controlled trial. All wounds treated with NXB achieved complete eschar removal. Time to complete eschar removal (from informed consent) was 0.9 days for NXB vs 6.5 days for SOC (P < .001). The incidence of surgical excision was 7.9% for NXB vs 73.3% for SOC (P < .001). Seventeen of these children participated in a phase III‐b follow‐up study (9 NXB and 8 SOC). The average long‐term modified Vancouver Scar Scale scores were 3.4 for NXB‐treated wounds vs 4.4 for SOC‐treated wounds (NS). There were no significant treatment‐related adverse events. Additional studies are needed to strengthen these results.
Introduction
Enzymatic debridement (ED) as a noninvasive method is widely used and has been researched in several studies. The influence of key components of the trauma and overall treatment on healing time are often underrepresented. This paper describes the results from 56 wounds treated in a burn unit to evaluate factors influencing the healing time.
Methods
From all patients admitted to our unit from the year 2014 to 2016, 56 were treated with ED. Preclinical data and clinical data were compared in a retrospective review. Patients were divided into two groups with a separator of healing time of 30 days.
Results
ED was provided in 56 wounds in 52 patients on average to 7.0% ± 6.0 %, median 4.8% of patient’s body surface area. Comparing the group with a healing time of more than 30 days and less than 30 days. Statistically significant differences with a p< 0.05 were found in the rate of preclinical intubations, inhalation injuries, the application of fluids before admission, the type of dressing used and the BAUX index. Highly significant differences with a p< 0.01 were found in the ratio of pseudoeschars which had to be operated on and in the modified BAUX index (MBI). Mostly used dressings were a polylactic membrane (PLM) and silicone dressings. In the silicone group, MBI was significantly higher than in the polylactic group and healing time was significantly faster in the PLM group. Comparing groups with a higher than average MBI of 67.5 the PLM and the silicone group had a comparable MBI (p=0.337), but the PLM group had a five days shorter healing time of 43 days (p=0.2768). In a logistic regression formula over all PLM and Silicone patients (Days for healing after ED = 1.53 + 8.9 * dressing (PLM=1, silicone=2) + 0.35*MBI - 5.15483*incomplete debridement (Yes=1, No=0) + 7.96*pseudoeschar to be operated on (Yes=1, No=0) the influence of dressings could be demonstrated. No statistical differences (p >0.05) could be found in age, etiology of burn (fire scald, electric current injury or electrical arch with a p=0.4), location of accident out- or inside a building, cold water therapy applied or not, in TBSA, percentage of partial deep burns and full-thickness burns or the percentage of patients taken to ICU as inpatients and the timing of ED as well as the completeness of ED and in ABSI.
Conclusions
Healing time was dependent on parameters such as preclinical intubations, inhalation injuries, dressings used, and the severity calculated by MBI. Dressings are one of the few settings which can be changed proactively to achieve better outcomes. PLM over all clinical conditions have a shorter healing time (31 days) compared to silicon dressings (49 days)
Applicability of Research to Practice
Immediate.
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