Demonstration of the safety and effectiveness of the RECELL® System combined with split-thickness meshed autografts for the reduction of donor skin to treat mixed-depth burn injuries.

INTRODUCTION: Split-thickness skin grafts (STSG) are the standard of care (SOC) for burns undergoing autografting but are associated with donor skin site morbidity and limited by the availability of uninjured skin. The RECELL® Autologous Cell Harvesting Device (RECELL® System, or RECELL) was developed for point-of-care preparation and application of a suspension of non-cultured, disaggregated, autologous skin cells, using 1cm2 of the patient's skin to treat up to 80cm2 of excised burn. METHODS: A multi-center, prospective, within-subject controlled, randomized, clinical trial was conducted with 30 subjects to evaluate RECELL in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (RECELL treatment) for the treatment of mixed-depth burns, including full-thickness. Treatment areas were randomized to receive standard meshed STSG (Control treatment) or RECELL treatment, such that each subject had 1 Control and 1 RECELL treatment area. Effectiveness measures were assessed and included complete wound closure, donor skin use, subject satisfaction, and scarring outcomes out to one year following treatment. RESULTS: At 8 weeks, 85% of the Control-treated wounds were healed compared with 92% of the RECELL-treated wounds, establishing the non-inferiority of RECELL treatment for wound healing. Control-treated and RECELL-treated wounds were similar in mean size; however, mean donor skin use was significantly reduced by 32% with the use of RECELL (p<0.001), establishing the superiority of RECELL treatment for reducing donor skin requirements. Secondary effectiveness and safety outcomes were similar between the treatments. CONCLUSIONS: In combination with widely meshed STSG, RECELL is a safe and effective point-of-care treatment for mixed-depth burns without confluent dermis, achieving short- and long-term healing comparable to standard STSG, while significantly decreasing donor skin use.

Parent vs burn-injured child self-report: contributions to a better understanding of anxiety levels.

Anxiety disorders are the most commonly reported form of mental health problem among youth, but they often go undiagnosed and untreated. This study examined the relationship between burn-injured youths' self-reported anxiety levels, as compared with their parent's perceptions of their child's emotional well-being. Burn-injured children were invited to voluntarily complete the Child Version of the 41-item survey, Screen for Child Anxiety Related Disorders, which consists of five anxiety subscales as well as a Total Anxiety Score. Parents were invited to complete the Parent Version. Sixty-three parent-child dyads, with girls (57%) and boys (43%), completed surveys. Mothers (73%) fathers (16%), and other caregivers (11%) participated. Youth mean age was 12.63 years and 60% reported visible burn scars. Matched-pairs t-tests were used to compare parent and child reports. Significantly lower mean scores were found between Screen for Child Anxiety Related Disorders Total Anxiety Score--Parent mean score of 10.52 vs the Youth mean score 21.06 (P<.001), as well as on all subscales including; panic disorder/somatic symptoms (P<.001), generalized anxiety disorder (P=.004), social anxiety disorder (separation anxiety (P<.001), and school avoidance (P<0.001). Results indicate that parents may be severely underestimating the psychological well-being of burn-injured youth. Findings emphasize the importance of a comprehensive approach in assessment for anxiety, involving the collection of feedback from both child and parent. Asking children for input into their psychological well-being is important. This study reinforces the need for a course of ongoing patient and parent education.

A multicenter review of toxic epidermal necrolysis treated in U.S. burn centers at the end of the twentieth century.

Toxic epidermal necrolysis (TEN) is a potentially fatal disorder that involves large areas of skin desquamation. Patients with TEN are often referred to burn centers for expert wound management and comprehensive care. The purpose of this study was to define the presenting characteristics and treatment of TEN before and after admission to regional burn centers and to evaluate the efficacy of burn center treatment for this disorder. A retrospective multicenter chart review was completed for patients admitted with TEN to 15 burn centers from 1995 to 2000. Charts were reviewed for patient characteristics, non-burn hospital and burn center treatment, and outcome. A total of 199 patients were admitted. Patients had a mean age of 47 years, mean 67.7% total body surface area skin slough, and mean Acute Physiology and Chronic Health Evaluation (APACHE II) score of 10. Sixty-four patients died, for a mortality rate of 32%. Mortality increased to 51% for patients transferred to a burn center more than one week after onset of disease. Burn centers and non-burn hospitals differed in their use of enteral nutrition (70 vs 12%, respectively, P < 0.05), prophylactic antibiotics (22 vs 37.9%, P < 0.05), corticosteroid use (22 vs 51%, P < 0.05), and wound management. Age, body surface area involvement, APACHE II score, complications, and parenteral nutrition before transfer correlated with increased mortality. The treatment of TEN differs markedly between burn centers and non-burn centers. Early transport to a burn unit is warranted to improve patient outcome.

Prospective trial of thick vs standard split-thickness skin grafts in burns of the hand.

For best function and appearance, thick skin grafts for hands are generally preferred to thinner grafts. But how thick is thick enough? This prospective randomized trial was designed to compare 0.015-inch skin grafts for burned hands to hand grafts that are 0.025 inches thick. Consecutive patients receiving skin grafts to hands were randomized to have sheet grafts using donor sites of 0.015-inch or 0.025-inch thickness. To prevent delayed healing and potential hypertrophic scarring, the thick graft donor sites were grafted with 0.008-inch grafts. There were no significant differences in range of motion, final appearance, or patient satisfaction between the two groups at 1 year. There were problems with donor site healing in both groups. We recommend that hand grafts for adults be at least 0.015 inches thick but do not see an advantage to the use of very thick (0.025-inch) grafts, even with thin split-thickness skin grafts to the donor site.

Developing a local protocol for the management of lipid disorders in general practice.

Guidelines and protocols are increasingly becoming part of routine clinical practice. A standardised methodology has been proposed for the development of national guidelines based on principles which are known to effect validity. However, less is known about the most appropriate methodology for the development of local protocols. A case study is presented of the development of a local protocol for the management of lipid disorders in primary care in Grampian. It highlights the practicalities of such a process and identifies lessons for others who may wish to develop local protocols.