LIBERTI: A SMART study in plastic surgery.

BACKGROUND/AIMS: Laser treatment of burns scars is considered by some providers to be standard of care. However, there is little evidence-based research as to the true benefit. A number of factors hinder evaluation of the benefit of laser treatment. These include significant heterogeneity in patient response and possible delayed effects from the laser treatment. Moreover, laser treatments are often provided sequentially using different types of equipment and settings, so there are effectively a large number of overall treatment options that need to be compared. We propose a trial capable of coping with these issues and that also attempts to take advantage of the heterogeneous response in order to estimate optimal treatment plans personalized to each individual patient. It will be the first large-scale randomized trial to compare the effectiveness of laser treatments for burns scars and, to our knowledge, the very first example of the utility of a Sequential Multiple Assignment Randomized Trial in plastic surgery. METHODS: We propose using a Sequential Multiple Assignment Randomized Trial design to investigate the effect of various permutations of laser treatment on hypertrophic burn scars. We will compare and test hypotheses regarding laser treatment effects at a general population level. Simultaneously, we hope to use the data generated to discover possible beneficial personalized treatment plans, tailored to individual patient characteristics. RESULTS: We show that the proposed trial has good power to detect laser treatment effect at the overall population level, despite comparing a large number of treatment combinations. The trial will simultaneously provide high-quality data appropriate for estimating precision-medicine treatment rules. We detail population-level comparisons of interest and corresponding sample size calculations. We provide simulations to suggest the power of the trial to detect laser effect and also the possible benefits of personalization of laser treatment to individual characteristics. CONCLUSION: We propose, to our knowledge, the first use of a Sequential Multiple Assignment Randomized Trial in surgery. The trial is rigorously designed so that it is reasonably straightforward to implement and powered to answer general overall questions of interest. The trial is also designed to provide data that are suitable for the estimation of beneficial precision-medicine treatment rules that depend both on individual patient characteristics and on-going real-time patient response to treatment.

Fat Grafting for Neuropathic Pain After Severe Burns.

BACKGROUND: Chronic neuropathic pain after burn injury is a significant problem that affects up to 29% of burn patients. Neuropathic burn scar pain is a challenge for plastic and burn surgeons, who have limited solutions. Fat grafting, with its mechanical and regenerative qualities, can improve neuropathic pain from various traumatic and postsurgical etiologies, but its effectiveness in neuropathic burn scar pain has yet to be demonstrated. In this study, the possible role of lipotransfer in treating neuropathic burn scar pain is explored, focusing on safety, graft take, and short-term efficacy. METHODS: We performed an institutional review board-approved, retrospective case review of 7 patients with chronic, refractory neuropathic pain, who underwent fat grafting to burn scars. These patients had failed conventional therapy, which included pharmacologic, medical, and laser treatment of the burn scars. Each patient had 2 sessions of fat grafting, spaced 2 months apart. The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to assess pain perception, with patients answering the questionnaire before and after fat grafting, to assess subjective outcomes. RESULTS: Six of 7 patients had improvement in neuropathic pain after fat grafting, permitting reduction in their neuropharmacologic regimen. Tinel sign, present in all patients preoperatively, was absent on examination in all patients at follow-up. Three of the 5 patients who completed PROMIS questionnaires had PROMIS scores indicating improvement in pain by 1-year follow-up. One patient had similar preoperative and postoperative PROMIS scores, and 1 patient had an increase in pain at follow-up; however, he had suffered an additional burn to the same extremity. Analysis of pooled mean PROMIS scores reflects a statistically significant improvement in subjective outcomes by 1-year follow-up. Donor-site seroma in 1 patient was the only complication, with no cases of infection, wound breakdown, or graft loss. CONCLUSIONS: Adipose tissue can be safely grafted into burn scars and may improve symptoms in patients with refractory neuropathic pain after burn injury. Further translational and clinical research is necessary to elucidate mechanisms of action, indications, optimal type of transfer, and long-term effectiveness.

Efficacy of intense pulsed light for the treatment of burn scar dyschromias: a pilot study to assess patient satisfaction, safety, and willingness to pay.

INTRODUCTION: No treatment algorithms exist to reliably treat burn scar dyschromias. Intense pulsed light (IPL) has been used successfully to treat hyperpigmentation disorders, but has not been studied extensively in the treatment of burn scars. The purpose of this investigation was to assess clinical efficacy and patient satisfaction with IPL for the treatment of burn scar dyschromia. METHODS: Patients with burn scar dyschromias were treated using the Lume 1 platform (Lumenis) to target pigmented lesions, using fluences between 10 and 22 joules/cm and filters ranging from 560 to 650 nm. At the conclusion of the study, providers assessed changes in burn scar dyschromia, whereas patients were queried regarding satisfaction and perceived efficacy, using a 1 to 5 Likert scale. The patients, who were not charged for the IPL treatment, were queried regarding willingness to pay. RESULTS: Twenty patients (mean age, 35.4 years; mean total body surface area, 27.6%; mean composite Fitzpatrick score, 3.9) underwent IPL treatment of burn scar dyschromias, an average of 3.2 years after injury. Mean fluence was 15.4 J/cm (range, 10-22 J/cm), and the most common filter used was 590 nm (range, 560-650 nm). Mean area treated was 90.7 cm, with a range of 4 to 448 cm. Complications included pain (4), hyperpigmentation (1), and blistering (2). Sixteen patients noted mild to moderate improvement, reporting a 4.5 for efficacy and a 4.4 for satisfaction. Regarding willingness to pay, patients would spend a mean of U.S. $7429 to completely remove their scars, but only a median of U.S. $350 to get the actual results that they received. Mean length of follow-up was 3.8 months, with a standard deviation of 2.2 months. CONCLUSIONS: Patients perceived IPL as an efficacious modality in the treatment of burn scar dyschromia, with a high level of satisfaction, despite the potential for morbidity. However, we are reluctant to recommend IPL for routine treatment of burn scar dyschromias, given only minimal improvement observed, potential for complications, and a willingness to pay that is lower than the cost of providing care.

Improving comfort and throughput for patients undergoing fractionated laser ablation of symptomatic burn scars.

INTRODUCTION: Utilization of fractionated ablation with a carbon dioxide (CO2) laser has shown to be efficacious in the management of symptomatic burn scars. Although effective, this procedure is painful and burn patients traditionally evidence low pain tolerance. For this reason intravenous anesthesia is used during these procedures. However, operative anesthetics and intravenous opioids are associated with patient discomfort postoperatively and prolonged recovery times. The American Society of Anesthesiologists' (ASA) Task Force on Acute Pain Management for the perioperative setting recommends the use of multimodal anesthesia, including the use of regional blockade with a local anesthetic. A quality improvement project was implemented to incorporate this practice and evaluate outcomes. The main goal of this project was to improve patient comfort as evidenced by improved pain scores with a decreased requirement for intravenous opioids post-procedure. The secondary goal of this project was to improve patient throughput in the setting of an outpatient surgical facility as evidenced by decreased time in the facility. METHODS: A historic cohort of 36 cases was compared to 36 cases managed under the ASA guidelines for multimodal anesthesia utilizing a topical local anesthetic. Statistical analysis included a t-test for continuous variables while chi square was utilized to analysis dichotomous variables. RESULTS: Intravenous narcotic utilization and mean pain scores in the recovery phase of care were significantly reduced as a result of adoption of the ASA recommendations. Throughput time increased by 36 minutes; notably in the preoperative phase, while patient movement through the procedural phase was significantly decreased as was procedure to discharge times. CONCLUSIONS: Implementing the use of a topical anesthetic as a component of multimodal anesthesia for patients undergoing fractionated laser ablation of symptomatic burn scars can significantly decrease patient pain and the need for intravenous opioids during the recovery phase of care. Increased overall throughput times were noted primarily in the preoperative period, while procedure to discharge times decreased. As operative and recovery phases represent higher operational costs, decreased time in these areas represent potential cost savings for the facility.

Laser resurfacing and remodeling of hypertrophic burn scars: the results of a large, prospective, before-after cohort study, with long-term follow-up.

OBJECTIVES: Hypertrophic burn scars produce significant morbidity, including itching, pain, stiffness, and contracture, but best management practices remain unclear. We present the largest study to date that examines long-term impact of laser therapies, a potentially transformative technology, on scar remodeling. METHODS: We conducted a prospective, before-after cohort study in burn patients with hypertrophic scars. Pulsed-dye laser was used for pruritus and erythema; fractional CO2 laser was used for stiffness and abnormal texture. Outcomes included (1) Vancouver Scar Scale (VSS), which documents pigmentation, erythema, pliability, and height, and (2) University of North Carolina "4P" Scar Scale (UNC4P), which rates pain, pruritus, paresthesias, and pliability. RESULTS: A total of 147 burn patients (mean age, 26.9 years; total body surface area, 16.1%) received 415 laser sessions (2.8 sessions/patient), 16 months (median) after injury, including pulsed dye laser (n = 327) and CO2 (n = 139). Laser treatments produced rapid, significant, and lasting improvements in hypertrophic scar. Provider-rated VSS dropped from 10.43 [standard deviation (SD) 2.37] to 5.16 (SD 1.92), by the end of treatments, and subsequently decreased to 3.29 (SD 1.24), at a follow-up of 25 months. Patient-reported UNC4P fell from 5.40 (SD 2.54) to 2.05 (SD 1.67), after the first year, and further decreased to 1.74 (SD 1.72), by the end of the study period. CONCLUSIONS: For the first time, ever, in a large prospective study, laser therapies have been shown to dramatically improve both the signs and symptoms of hypertrophic burn scars, as measured by objective and subjective instruments. Laser treatment of burn scars represents a disruptive innovation that can yield results not previously possible and may displace traditional methods of operative intervention.

A systematic review of advance practice providers in acute care: options for a new model in a burn intensive care unit.

INTRODUCTION: Accreditation Council for Graduate Medical Education mandated work-hour restrictions have negatively impacted many areas of clinical care, including management of burn patients, who require intensive monitoring, resuscitation, and procedural interventions. As surgery residents become less available to meet service needs, new models integrating advanced practice providers (APPs) into the burn team must emerge. We performed a systematic review of APPs in critical care questioning, how best to use all providers to solve these workforce challenges? METHODS: We performed a systematic review of PubMed, CINAHL, Ovid, and Google Scholar, from 2002 to 2012, using the key words: nurse practitioner, physician assistant, critical care, and burn care. After applying inclusion/exclusion criteria, 18 relevant articles were selected for review. In addition, throughput and financial models were developed to examine provider staffing patterns. RESULTS: Advanced practice providers in critical care settings function in various models, both with and without residents, reporting to either an intensivist or an attending physician. When APPs participated, patient outcomes were similar or improved compared across provider models. Several studies reported considerable cost-savings due to decrease length of stay, decreased ventilator days, and fewer urinary tract infections when nurse practitioners were included in the provider mix. CONCLUSIONS: Restrictions in resident work-hours and changing health care environments require that new provider models be created for acute burn care. This article reviews current utilization of APPs in critical care units and proposes a new provider model for burn centers.

Logistics of building a laser practice for the treatment of hypertrophic burn scars.

INTRODUCTION: Although lasers can improve burn scars, such treatment has not been adopted universally, due to operational challenges starting a practice and the perception that such a program is not financially viable. We report the logistics of building a laser practice for the treatment of hypertrophic burn scars. METHODS: We analyzed the clinical, operational, and financial components of our laser practice, focusing on treatment of hypertrophic burn scars, using pulsed dye laser, fractional CO2 laser, and intense pulsed light. Cases were performed in an operating room, with anesthesia, after preauthorization. We examined professional charges and collections, case time, variable and indirect expenses, and breakeven volumes. RESULTS: Our practice grew as follows: 2008, 1 case; 2009, 44 cases; 2010, 169 cases; and 2011, 415 cases. Overall collection rate was 32.1%. Expenses incurred by the provider, per 8-hour session, included laser rental/lease ($2375), personnel salaries ($1900), and physician overhead ($808), for a total cost of $5083. Mean charge was $1642 per case; mean collection was $527 per case. Median case time (procedure plus turnover) was 40 minutes. In this model, breakeven volume is 9.7 cases per day; breakeven time is 49.7 minutes. Provider profit margin for 10 cases per day, or 83% capacity utilization, is $187 per day (income - expenses = $5270 - $5083). CONCLUSIONS: Despite high costs associated with starting and operating a laser practice for the treatment of hypertrophic burn scars, a sustainable enterprise can be achieved when the provider has accrued enough volume to batch cases over an entire day. Critical to achieving breakeven is preauthorization, controlling overhead, and efficient throughput.

Incidence and management of adverse events after the use of laser therapies for the treatment of hypertrophic burn scars.

INTRODUCTION: Hypertrophic burn scars may generate significant morbidity, due to intense pruritus, persistent dysesthesias, and contracture. Although treatment with pulsed dye laser and fractional CO2 laser may improve symptoms, incidence of secondary wound complications is not well known. We examined the adverse event profile of laser therapies for the treatment of hypertrophic burn scars. METHODS: We performed a descriptive, retrospective, 6-month study of all patients who underwent laser therapies, at an accredited regional burn center, to improve the vascularity, texture, thickness, and stiffness of symptomatic burn scars. Data regarding skin type, mechanism, area treated, and laser parameters were collected. Main outcome measures included pigmentation changes, blistering, rash, infection. χ analysis and Student t test were used to evaluate associations between variables. RESULTS: A total of 95 patients underwent 163 treatment sessions (mean, 2.7 sessions/patient) with pulsed dye laser (71%), CO2 laser (22%), and other lasers (7%). Forty-one adverse events were recorded: hyperpigmentation (2%), hypopigmentation (12%), mild blistering (27%), pain (37%), rash (7%), fever (10%), and infection (2%). Patients with scald burns were more likely to develop blistering, rash, and fever after treatment (all P < 0.05). Higher Fitzpatrick skin type was associated with hypopigmentation and blistering, whereas CO2 laser was associated with increased postoperative pain (all P < 0.05) CONCLUSIONS: Despite the frequent occurrence of pain and mild blistering after laser treatment of hypertrophic burn scars, major adverse effects were exceedingly rare, with improvement noted in all patients. Patients with higher Fitzpatrick skin types must be handled with care, to avoid complications of blistering and hypopigmentation.

Prospective, before-after cohort study to assess the efficacy of laser therapy on hypertrophic burn scars.

INTRODUCTION: Hypertrophic burn scars produce significant morbidity, including itching, pain, stiffness, and contracture. Best practices for management continue to evolve. Lasers have recently been added to treatment algorithms, but indications and efficacy have not been fully defined. We studied the impact of laser therapies on hypertrophic burn scars. METHODS: We conducted a prospective, before-after study in burn patients with hypertrophic scars. Procedures were performed more than 6 months after burn injury and were repeated monthly. The pulsed-dye laser was used for pruritus and erythema, whereas the fractional CO2 laser was used for stiffness and abnormal texture. All procedures were performed in the OR, with anesthesia. Outcomes are as follows: (1) Vancouver Scar Scale (objective changes in pigmentation, erythema, pliability, height; range, 0-15) and (2) UNC Scar Scale (subjective changes in pain, itching, tingling, stiffness; range, 0-12). Before-after scores were compared by Student t test, with significance assigned to P values of <0.05. RESULTS: During 2011, we treated 147 patients (mean age, 26.9 years; mean TBSA, 16.1%) over 415 sessions (2.8 sessions/patient), including pulsed dye laser (n = 327) and CO2 (n = 139), mean surface area of 83 cm. Etiology included flame (75), scald (37), and other (35). Treatments occurred 16 months (median) and 48 months (mean) after burn injury. Vancouver Scar Scale decreased from 10.4 (SD, 2.4) to 5.2 (1.9) (P < 0.0001). UNC Scar Scale decreased from 5.4 (2.5) to 2.1 (1.7) (P < 0.0001). Mean length of follow-up was 4.7 months. CONCLUSIONS: Laser therapies significantly improve both the signs and symptoms of hypertrophic burn scars, as measured by objective and subjective instruments.

Shine on: Review of Laser- and Light-Based Therapies for the Treatment of Burn Scars.

Restoration of form and function after burn injury remains challenging, but emerging laser and pulsed light technologies now offer hope for patients with hypertrophic scars, which may be associated with persistent hyperemia, chronic folliculitis, intense pruritis, and neuropathic pain. In addition to impairing body image, these scars may limit functional recovery, compromise activities of daily living, and prevent return to work. Three different platforms are now poised to alter our reconstructive algorithm: (1) vascular-specific pulsed dye laser (PDL) to reduce hyperemia, (2) ablative fractional CO(2) laser to improve texture and pliability of the burn scar, and (3) intense pulsed light (IPL) to correct burn scar dyschromia and alleviate chronic folliculitis. In this paper, we will provide an overview of our work in this area, which includes a systematic review, a retrospective analysis of our preliminary experience, and interim data from our on-going, prospective, before-after cohort trial. We will demonstrate that laser- and light-based therapies can be combined with each other safely to yield superior results, often at lower cost, by reducing the need for reconstructive surgery. Modulating the burn scar, through minimally invasive modalities, may replace conventional methods of burn scar excision and yield outcomes not previously possible or conceivable.

Performance of a dose-defining insulin infusion protocol among trauma service intensive care unit admissions.

BACKGROUND: Among critically ill patients, glycemic control reduces mortality and morbidities, but the use of intravenous insulin infusion is complicated by hypoglycemia. Having a standardized algorithm increases the likelihood of effective and safe utilization of intravenous insulin therapy. A tabular dose-defining protocol for intravenous insulin infusion is described, containing design elements intended to minimize risk for hypoglycemia while seeking control in a narrow target range, and performance is evaluated among critically ill trauma service patients. METHODS: The protocol assigns insulin infusion rate (IR) for ranges of blood glucose (BG). The columns are arranged in order of increasing maintenance rate (MR) for insulin infusion. Patient column assignment is determined according to rate of change of BG. During stable column assignment, the IR is a function of column MR and BG. Within-column, the protocol formula provides that (a) for BG between 70 mg/dL and target BG, the IR increases exponentially to the column MR; and (b) for BG above upper target BG range, the IR increases linearly as an adaptation of the rule of 1800, with slope determined by the column MR. Values for IR calculated by formula are rounded to correspond to BG ranges of the table. Performance was assessed in 27 sequential runs among 24 trauma service patients admitted to a surgical intensive care unit (2004-2005). RESULTS: Using point-of-care measurements, mean preinfusion BG was 230.0 +/- 67.9 mg/dL. BG < 140 mg/dL was reached during all 27 runs (median time 5.0 h), and target BG was < 110 mg/dL during 25 runs (median time 11.0 h). For the group of runs attaining target before interruption of insulin infusion, the average +/- SD of the principal measure of glycemic control, the within-run mean BG, was 113.7 +/- 14.8 mg/dL (coefficient of variation 13%, n = 25 runs). After attaining target, the average within-run SD for BG was 22.9 mg/dL. The within-run frequency of hypoglycemic measurements (BG < 70 mg/dL) as a percentage of BG determinations was 2.4%. In this series, no instance of BG <50 mg/dL was seen. CONCLUSIONS: This report describes a nurse-implemented tabular protocol for intravenous insulin infusion having the advantages of efficacy, safety, and simplicity of use. Wide variability of IR in the neighborhood of BG 110 mg/dL is associated with stable BG response, and protection against hypoglycemia is achieved by rapid decline of IR at BGs in or below the target range.