Burn Wound Management: MedSun Small Sample Survey Summary
MedSun: Newsletter #71, April 2012

Survey Topic: Burn Wound Management - Summary of Responses
Year Conducted: 2011
Commissioner's Fellowship Project

Background
Each year more than a million people in the US sustain burn injuries, with approximately 450,000 receiving medical treatment. In spite of progress in burn care leading to increased survivability numerous areas for improvement and innovation persist.

FDA would like to better understand the current state of burn wound management to identify unmet needs and evaluate obstacles that potentially hinder product development and the use of burn care products in the clinical setting. This survey effort addresses the use of current and new products, technologies and advancements in burn care and their effect on clinical outcomes. Information from the survey will help FDA incorporate evolving thinking about the practice of burn care to determine changing needs, use innovation, and identify the barriers and perceptions that hamper advancement in burn care for patients.

The survey respondents include eight surgeons who are Directors of Burn Units and a Registered Nurse who is a Nursing Director of a Burn Unit. Two of nine respondents practice in pediatric hospitals. Of the eight surgeons, six specialize in General Surgery and two in Plastic Surgery. The information that follows is a summary of responses.

Summary
The size of the burn centers in the survey ranges from 5 to over 40 beds with the majority of units having 15 beds or less. Most have the capacity for overflow, if needed. One burn center has a dedicated operating room and another has dedicated therapy rooms. Seven of nine burn centers are verified through the American Burn Association and one center is in the process of becoming verified.

Over the last three years, respondents report having an average census up to 10 patients per day with one larger center averaging up to 29 patients per day. Most have not seen an upward trend in census except for one respondent that attributes the increase to an extensive outreach campaign promoting their outpatient services.

Most of the burn centers are located in an urban setting and receive patients from a large geographic area. The total number of admissions for all of the burn centers ranges from 170 to 475 patients per year. A few respondents report they are seeing more male patients than females that are between the ages of 30 to 45 years old.

The average length of stay for four of eight centers ranges from 4 to 5 days, to 7 to 8 days. The remaining four centers report less than 1 day per percent burn of the patient’s total body surface area.

Some of the changes in demographics with adult patients over the past few years include a decrease in larger burns and a bigger trend toward earlier discharge and more outpatient treatment. This is due particularly to the use of dressings that are changed now every seven days instead of once or twice a day. Also, many respondents are seeing more elderly patients with chronic diseases and more significant burns from scalding, smoking, misuse of accelerants, and the use of oxygen in the home setting.

Respondents from pediatric burn centers have also seen a decrease in larger burns with admissions remaining fairly consistent for patients up to two years old with mostly scalding burns. However, one respondent reports seeing more patient admissions with mental illness, drug and alcohol-related problems, injuries due to other risky behaviors, and some airbag type injuries in teenagers.

All but one center participates in research that is clinical, translational or basic science. Some of the burn centers are currently involved in clinical research that is multi-center, industry-sponsored, investigator-initiated, and observational.

Home Health Services plays a role in the care and management plan for five burn centers and a very major role for one where most patients are discharged to home with an outpatient service that is very active. For the remaining respondents, home health plays a minimal role for several reasons such as limited knowledge of burn wound care by home health providers, many post operative patients are discharged to rehabilitation or skilled nursing facilities for dressing changes, patients with smaller burns provide care for themselves, and many patients return to the hospital for physical and occupational therapy in the outpatient department. Some respondents also say that involving home health services is often driven by the patient’s insurance.

According to one respondent, wound care is the most common reason for getting home health involvement. Other reasons for home health services include pain management, outpatient therapy, and when dealing with social issues, such as, pediatric patients who are hospitalized under suspicion of child abuse. One burn center program is developing a more integrated system with home health to manage burns so that more effective care can be provided in the home. This particular outreach program involves having outpatient nursing staff accompany home health staff on patient visits and home health staff visits to the outpatient center. The respondent for this burn center program believes that if this relationship is strengthened it may influence and decrease readmissions to the hospital.

All respondents believe that patient compliance is a factor in the outcome of the individual’s care and utilize several approaches to promote better outcomes particularly when a patient is non-compliant. For example in the pediatric setting, longer-wear dressings are often used if there’s a question of patient compliance in the home setting. Also, if one appointment is missed staff contacts the authorities to get the child because it’s seen as a child abuse situation. For other centers, adult patients will be kept in the hospital to prevent wound failure for several reasons. These reasons include: the risk of patients hurting themselves by not complying, the need to wait and see if the graft takes, if home health services for the area are not good, or if insurance is an issue. In some situations, non-compliant patients are often sent to skilled nursing facilities as a “bridge” to independent living.

Most respondents use several types of professional resources to guide their patient care. However, their primary resources are research-based and peer-reviewed literature. Several use guidelines from associations such as the American Burn Association (published in the Journal of Burn Care and Research), the Society of Critical Care and Medicine, the American College of Surgeons, and some also use guidelines from individual states. Additional resources include using a burn handbook, attending professional meetings, talking with colleagues, obtaining expert opinions, and following hospital policies and procedures.

All respondents have a “standard of care” or treatment modalities in place for burn wound management that includes early debridement, topical wound care, and rapid assessment and determination for early excision and grafting. All respondents use algorithms that are based on the degree and percentage of the burn and follow a pathway for regulating fluids, lab work, medications, and vitamins.

Respondents vary in their standard approach to treatment in several areas, such as, the use of enzymatic and non-enzymatic debriding agents, the amount of time before a patient is taken to the operating room for excision of large, third degree or deep second degree burns, and when selecting products for skin grafts. Of nine respondents, five use non-enzymatic debriding agents, one is decreasing use, two respondents who practice in pediatric settings never use them, and one didn’t specify using them or not. When respondents discuss taking patients to the operating room for initial excision and grafting of third or deep second degree wounds, the time frames range from within the first 24-48 hours to 5 days after admission to the burn unit. Regarding products for skin grafts, most use superficial silver dressings after wound debridement and ‘artificial skin substitutes’ on donor sites. Several mention not using cadaver skin for donor sites because of prior disappointment with size or thickness and difficulty with curling edges.

Most respondents report having a multi-disciplinary team in their center that conducts rounds at least once a week. All have at least one attending physician that is a general surgeon or plastic surgeon and also have team members who are nutritionists, physical therapists, respiratory therapists and nurses. Some teams also include pharmacists, anesthesiologists, surgical residents, advance practice nurses, and physician assistants. When discussing how burn centers function with regard to who performs procedures, all respondents state that the attending surgeons or Medical Director performs all major procedures and may have residents, burn fellows or members of their critical care team insert central and arterial lines and perform other bedside procedures.

In a discussion about staff and training, one respondent focuses on the need to integrate other hospital staff to the burn center’s processes and concepts involving early wound excision. In this particular center, any new product in the burn center is integrated with other services and new hospital staff receives wound care training as part of the individual’s competency training. Also according to procedure, if a patient’s wound is not excised within the burn center’s standard time frame, it’s communicated and included in the hospital’s peer review process and justification is needed as to why the excision didn’t occur.

Newly marketed products are incorporated in most respondents’ centers. However, there is some variation in the responses from those who are just learning about new products to others who say they try too many. All respondents have a hospital-based product evaluation committee or value analysis committee. Typically, these committees follow their institutionally established process or procedure to evaluate and approve the purchase and use of new products. Seven of eight respondents believe there are no barriers to bringing in a new product to the hospital if it appears better and promotes faster healing. One respondent does experience resistance from the hospital to try new things but also believes that new products should come with protocols, learning objectives for nurses, comparisons with historic data, etc. Examples of characteristics or criteria most use for evaluating new products are ease of use, lower cost and better value, less pain, and fewer future hospitalizations and surgeries for patients. To further reduce costs, one respondent reports keeping only enough stock on hand for two to three surgeries at a time and others mention they are often asked what older, similar products currently in stock will be removed and replaced with the newer ones. The cost of silver dressings remains an issue. One respondent states that before considering use of a newer silver dressing they make sure the product is cleared by the Food and Drug Administration and that efficacy data is readily available, mainly through peer review publications. Almost all respondents regard pain reduction as a priority and try to use longer-wear dressings and longer acting agents to minimize the number of dressing changes and subsequent trauma for the patient. Also, most respondents have a process in place at their center to trial new products for a period of time and then based on evaluations and other reviews are able to get it on the hospital’s official formulary.

The products and therapeutics used most frequently varies among burn centers. One respondent mentions occasionally using enzymatic debriding agents and frequently using hydromechanical debridement to excise eschar. The majority of respondents use silver impregnated dressings and mention they use many other products too. Some report using antibacterial/antifungal solutions and other types of topical wound dressings for acute partial thickness burn management and silicone sheets after healing for scar management. Also, many respondents mention using dermal regeneration templates as a means to facilitate definitive closure of full thickness burns.

Six of eight respondents believe they have the products at their centers to serve their clinical and patient needs but add that improvements are necessary. For example, there are always ongoing issues related to the basic science of would healing where improvements would help promote faster healing or help with a patient’s pain control. One respondent adds however, that the burn market is a small niche market, and it’s an investment and may be a capital gamble for a manufacturer to develop a ‘skin substitute’ indicated only for burns.

When considering burn care additions and innovations over the past 15 years, about half of the respondents think that ‘skin substitutes’ and longer lasting silver dressings have had an impact on patient care particularly with healing and less scarring. Other changes making a difference in patient care are advances in critical care management and pharmacology, enteral nutrition, topical hemostatics, and the use of cultured autologous epithelial sheets. Early excision and hydromechanical debridement also have had an impact along with better resuscitation guidelines; however, one respondent notes that problems still need to be addressed regarding over-resuscitation (i.e. excessive fluid administration during the initial 48 hours post-injury that can lead to multi-systemic organ dysfunction).

Respondents think there are several areas that pose the greatest need for innovation that can translate to improved patient outcomes. Several would like a user-friendly objective method to accurately diagnose the depth of a burn wound. Current laser Doppler flow instruments are cumbersome and expensive. One respondent suggests that a hand-held device would be better and easier to use. Other areas where innovation is needed is in the treatment of inhalation injuries, regenerative medicine, and with epithelial and full thickness skin replacements. Additionally, the treatment of scars particularly hypertrophic scars is an area where more research is needed to lead to better functional and cosmetic results for patients.

According to respondents, the gaps that exist in meeting patient needs are in the areas of psychological services and effective pain management. Many patients have post traumatic stress and adequate support and resources are needed for them particularly after discharge from the burn center. Also, providing sufficient pain control without causing other physiologic issues continues to be a challenge in burn management.

Most respondents feel there are no barriers that impact their ability to change patients’ care; however, some believe product expense remains an issue. One respondent believes that more recognition of burn centers by the government for their commitment to patient care is needed and adds that regionalization of burn care similar to what has been done with trauma care would be good. These approaches would bring this particular patient population together, promote better coordination and utilization of available burn beds, and expedite better product evaluation and development.

In addition to previous responses about therapeutics, diagnostics, interventions, etc., about where burn management may be lacking, respondents believe there are other needs as well. These include better modalities for permanent wound closure, better pain control and sedation protocols to minimize delirium in patients, better approaches to dealing with antibiotic resistance, improved products for neck wounds that prevent decubitus and allow for cervical spine imaging, and a need for research about the use of inhaled antibiotics for lung injuries. Also, one respondent believes that the use of telemedicine could have a huge impact in the burn community.



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Special Studies and Surveys are two of many tools the Agency is using to evaluate the public health impact of the potential problems associated with the use of medical devices. Additionally, FDA continues to receive adverse event reports from its Medical Device Reporting program. FDA will also continue to make use of the literature and other published information. FDA scientific, medical, nursing and engineering staff are made aware of the survey results as needed. If FDA believes there is a significant risk of adverse events as noted from the survey, it will combine those results with data gained from the other sources. FDA will work with the manufacturers and health care professional organizations to make important information known to the clinical community. Additionally, FDA continues to work with manufacturers to ensure the development, testing and promulgation of methods for reducing the risk associated with these devices and to minimize the complications from adverse events that may occur in the course of normal usage. If the results of any survey raise serious concerns about the safety of these devices, FDA may convene an Ad Hoc group of clinical and manufacturing representatives to discuss further actions.


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