Wound, pressure ulcer and burn guidelines – 2: Guidelines for the diagnosis and treatment of pressure ulcers, second edition

Abstract

Guidelines are documents systematically prepared to support medical experts and patients for making appropriate judgments in particular clinical situations. The Japanese Society of Pressure Ulcers (JSPU) published the Guidelines for the Prevention and Management of Pressure Ulcers in February 2009, which has undergone revisions leading to the publishing of the fourth edition in 2015. Their guideline was not intended solely for physicians, but for nurses, nutritionists, pharmacists, physical therapists, occupational therapists and other health-care professionals; it emphasized the prevention and care over the treatment. On the other hand, the present guideline, “Guidelines for the diagnosis and treatment of pressure ulcers”, placed more emphasis on the treatment. Both guidelines shared the same goal: systematically presenting evidence-based recommendations to support clinical decisions in the prevention, care and treatment of pressure ulcers, serving as a tool for improving the quality of diagnosis and treatment of pressure ulcer patients, and improving the care for pressure ulcers in Japan as a whole. The Wound, Pressure Ulcer and Burn Guidelines Drafting Committee (Table 1) was composed of members delegated by the Board of Directors of the Japanese Dermatological Association. The committee meetings were held gathering or through email since October 2008, and has drafted the guidelines for wounds in general, and other five related guidelines, including this guideline, by taking into consideration the opinions of the Scientific Committee, the Guideline Committee, and the Board of Directors of the Japanese Dermatological Association. The present guidelines reflect the current standards for diagnosis and treatment of pressure ulcers in Japan. However, the factors that a physician should take into consideration during diagnosis and treatment of a pressure ulcer are more diverse than those of other wounds; the patient's underlying disease, the situation of a care-providing facility, the patient's home and the locoregional conditions in which the patient resides should be considered. It is unlikely that the optimized treatment for an individual patient is in absolute agreement with these guidelines. Any deviation from these guidelines should not be the basis for citation in lawsuits or legal disputes. Chairperson: Hironobu IHN (Professor, Department of Dermatology and Plastic Surgery, Faculty of Life Sciences, Kumamoto University) Vice-chairperson: Takao TACHIBANA (General Manger, Department of Dermatology, Osaka Red Cross Hospital) Yuji INOUE (Director, Suizenji Dermatology Clinic) Sakae KANEKO (Associate Professor, Department of Dermatology, Shimane University Faculty of Medicine) Hiroyuki KANOH (Associate Professor, Department of Dermatology, Graduate School of Medicine, Gifu University) Yoichi SHINTANI (Director, Shintani Dermatology Clinic) Jun TSUJITA (Chair, Department of Dermatology, Social Insurance Inatsuki Hospital, Fukuoka Prefecture Social Insurance Hospital Association) Minoru HASEGAWA (Assistant Professor, Department of Dermatology, Faculty of Medical Sciences, University of Fukui) Hideki FUJITA (Associate Professor, Department of Dermatology, School of Medicine, Nihon University) Sei-ichiro MOTEGI (Lecturer, Department of Dermatology, Graduate School of Medicine, Gunma University) Andres LE PAVOUX (Director, Ichige Dermatology Clinic) Zenzo ISOGAI (Chief Physician, Division of Dermatology and Connective Tissue Medicine, Department of Advanced Medicine, National Center for Geriatrics and Gerontology) Ryokichi IRISAWA (Research Associate, Department of Dermatology, Tokyo Medical University) Masaki OTSUKA (Assistant Director, Division of Dermatology, Shizuoka Cancer Center) Takafumi KADONO (Associate Professor, Department of Dermatology, St. Marianna University School of Medicine) Monji KOGA (Lecturer, Department of Dermatology, Fuculty of Medicine, Fukuoka University) Kuninori HIROSAKI (Chief Physician, Department of Dermatology, Hokkaido Medical Care Center) Hiroshi FUJIWARA (Specially-Appointed Professor, Niigata University Medical and Dental Hospital; Chair, Department of Dermatology, Uonuma Institute of Community Medicine) Masatoshi ABE (Assistant Director, Sapporo Dermatology Clinic) Ryuta IKEGAMI (Chair, Department of Dermatology, JCHO Osaka Hospital) Taiki ISEI (Chair, Department of Dermatology, Osaka National Hospital) Hiroshi KATO (Lecturer, Department of Geriatric and Environmental Dermatology, Graduate School of Medical Sciences, Nagoya City University) Eiichi SAKURAI (Assistant Director, Sakurai Dermatology Clinic) Hideaki TANIZAKI (Lecturer, Department of Dermatology, Osaka Medical College) Takeshi NAKANISHI (Specially-Appointed Associate Professor, Department of Dermatology, Shiga University of Medical Science) Koma MATSUO (Director, Nakano Dermatology Clinic) Osamu YAMASAKI (Lecturer, Department of Dermatology, Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama University) Jun ASAI (Lecturer, Department of Dermatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine) Yoshihide ASANO (Associate Professor, Department of Dermatology, Faculty of Medicine, University of Tokyo) Takayuki ISHII (Chief Physician, Division of Dermatology, Toyama Prefectural Central Hospital) Yohei IWATA (Associate Professor, Department of Dermatology, Fujita Health University School of Medicine) Tamihiro KAWAKAMI (Associate Professor, Department of Dermatology, St. Marianna University School of Medicine) Masanari KODERA (Chair, Department of Dermatology, JCHO Chukyo Hospital) Manabu FUJIMOTO (Professor, Department of Dermatology, Faculty of Medicine, University of Tsukuba) Takaaki ITO (Lecturer, Department of Dermatology, Hyogo College of Medicine) Ryuichi KUKINO (Director, Kukino Dermatology Clinic) Yasuko SARAYAMA (Assistant Chair, Department of Dermatology, Kobe Rosai Hospital) Miki TANIOKA (Director, Tanioka Dermatology Clinic) Takeo MAEKAWA (Associate Professor, Department of Dermatology, Jichi Medical University) Hiroshi YATSUSHIRO (Chief Physician, Department of Dermatology, Fukui-ken Saiseikai Hospital) Masahiro AMANO (Professor, Department of Dermatology, Faculty of Medicine, University of Miyazaki) Yoichi OMOTO (Chief Physician, Department of Dermatology, Yokkaichi Municipal Hospital) Masakazu KAWAGUCHI (Associate Professor, Department of Dermatology, Yamagata University Faculty of Medicine) Keisuke SAKAI (Chair, Department of Dermatology, Minamata City General Hospital and Medical Center) Naotaka DOI (Research Associate, Department of Dermatology, Wakayama Medical University) Akira HASHIMOTO (Research Associate, Department of Dermatology, Tohoku University Graduate School of Medicine) Masahiro HAYASHI (Lecturer, Department of Dermatology, Yamagata University Faculty of Medicine) Naoki MADOKORO (Chair, Department of Dermatology, MAZDA Hospital) Yuichiro YOSHINO (Chair, Department of Dermatology, Japanese Red Cross Kumamoto Hospital) All expenses required for drafting these guidelines have been borne by the Japanese Dermatological Association, and no aid or financial support has been provided by specific organizations, enterprises or pharmaceutical companies. Furthermore, in the case that a committee member (Table 1) participating in the drafting of these guidelines was involved in the development of a specific, relevant drug, that member abstained from determining to what degree the item in question was recommended. Aside from that, each committee member has no conflict of interest to disclose in the drafting of these guidelines. Databases search: The key word search in Medline, PubMed, Japanese Medical Abstracts Society and Cochrane Database of Systematic Reviews, as well as the personal references of the committee members, were performed. Search period: The studies published between January 1980 and December 2013 were reviewed. More recent publications were also considered, if appropriate. Adoption criteria: Priority was placed on systematic reviews of randomized controlled trials (RCT) and on individual RCT. If they were not available, cohort studies and case–control studies were adopted. Case series studies were also used as references. Basic research studies were not considered as evidence in recommendation. The criteria adopted in the “Guidelines for the diagnosis and treatment of malignant tumors” described below, published by the Japanese Dermatological Association, were used as a reference for the classification of the evidence levels. Evidence level classification: The Minds Handbook for Clinical Practice Guideline Development 2014 was referenced for the recommendation levels. Classification of recommendation levels and descriptions: Recommendation levels: If the recommendation levels could not be determined, recommendation level “none” may be given. The recommendations appear with the strength of evidence (defined as A, B, C and D) and the recommendation level as in the following examples: Before the publication of these guidelines, those of annual progress in drafting were presented in the Annual Meetings of the Japanese Dermatological Association from 2012 to 2015, to solicit opinions from the association members in order to make necessary revisions. The present guidelines are scheduled to be updated in the next 3 or 5 years. However, if a partial update becomes necessary, it will be presented on the website of the Japanese Dermatological Association. Pressure ulcer: External force applied to the body reduces or blocks blood flow in the soft tissue between the bone and the skin surface. If this state continues for a certain period, the tissue sustains irreversible ischemic damage and develops into a pressure ulcer. Topical agents: Drugs that are applied through the skin or directly to skin lesions for localized treatment. They are prepared by compounding various drugs with a base. Dressing materials: Modern wound-dressing materials for creating a wet environment for wounds. Conventional sterilized gauze is excluded. Wound-dressing materials: Wound-dressing materials can be broadly divided into dressing materials (modern dressing materials) and medical materials such as gauze (classic dressing materials). The former are medical materials that provide conditions optimal for wound healing by maintaining a moist environment, and must be used selectively depending on the state of the wound and the amount of exudate. Gauze allows drying of the wound and cannot maintain a moist environment if exudate volume is insufficient. Medical materials other than conventional gauze that provide an optimal environment for wound healing by covering the wound and maintaining moisture may also be called wound-dressing materials or dressing materials. Occlusive dressing: All dressing methods used to avoid drying of wounds for moist wound healing are called occlusive dressings. This is a collective term for dressings using modern wound-dressing materials other than conventional gauze dressing. Wet-to-dry dressing: Dressing aimed at debridement performed by applying gauze saturated with physiological saline to the wound, and once the gauze has dried, non-selective removing of foreign material and necrotic tissue adhering to it occurs when it is changed. Surgical treatments: Surgery, surgical debridement and invasive treatments of subcutaneous pockets. Physical therapy: Treatment performed by applying stimulation to the body using physical means, which include physical energy such as heat, water, light, ultrashort waves, electricity, ultrasound, vibration, pressure and traction. Thermotherapy, cryotherapy, hydrotherapy, phototherapy, ultrashort wave therapy, electric stimulation therapy, ultrasound therapy, negative-pressure therapy, high-pressure oxygen therapy and traction therapy are variations of physical therapies. These are performed to mitigate pain, promote wound healing and increase the elasticity of tissues such as muscles and ligaments. “Physical therapy” is used as a general term for all these therapies, and the means for the treatment are conventionally called “physical agents” to avoid confusion. NPUAP pressure ulcer staging system: A classification of depth of pressure ulcers, a staging system proposed by the NPUAP in 1989. Conventionally, pressure ulcers have been classified into stages I, II, III and IV. Recently, however, the category of deep tissue injury (DTI) has been added based on the concept that deep areas may be damaged even without damage to the skin surface. Therefore, according to the new NPUAP pressure ulcer staging system issued in 2007, pressure ulcers are categorized into six stages: (suspected) DTI, stages I, II, III and IV, and unstageable (whether the depth of pressure ulcer is III or IV is impossible to determine). DESIGN: An assessment scale for evaluating the conditions of pressure ulcers introduced by the Japanese Society of Pressure Ulcers in 2002 as an assessment tool consisting of seven items: depth, exudate, size, inflammation/infection, granulation tissue, necrotic tissue and pocket. There are two types: one used for severity classification representing severe and mild using capital and lowercase letters, respectively, and the other for the evaluation of patient progress by quantifying the healing process to allow monitoring. The latter type exists as the 2002 version, and the 2008 revision (DESIGN-R® with the “R” standing for “rating”) was amended to provide a more accurate rating of severity as well as evaluation of the course of pressure ulcers. Deep tissue injury: The term used by the NPUAP in 2005, meaning a pressure ulcer without epidermal loss (stage I) in which there is a suspicion of damage to tissues deeper than subcutaneous tissue. In the NPUAP pressure ulcer staging system for pressure ulcers revised in 2007, “(suspected) deep tissue injury” was added as a new stage. It may be translated as “deep tissue damage” for damage other than pressure ulcers Nutrition support team (NST): The Japan Council for Nutritional Therapy (JCNT) calls nutritional management performed appropriately for individual patients and for the treatment of individual disorders “nutrition support” and defines a team of several professions including a physician, nurse, pharmacist, managerial dietician and clinical laboratory technician as the NST. Erosion: Cutaneous or mucosal loss not extending beyond the basement membrane (dermoepidermal junction, mucosa). Usually heals without leaving a scar. Ulcer: Cutaneous or mucosal loss extending beyond the basement membrane (dermoepidermal junction, mucosa). Usually leaves a scar after the cure. Decompression: Reducing contact pressure similarly to that of pressure reduction. Previously, reducing the pressure to less than 32 mmHg, considered to be the internal pressure of capillaries, was defined as decompression, and to 32 mmHg or above as pressure reduction, but this distinction is not made today. Body pressure-dispersion devices: Devices that reduce the pressure on a unit of body surface area due to contact with a support such as a bed or a chair by widening the contact area or by shifting the area under pressure over time to reduce the pressure at any single site over the long term. Devices used for patients in a recumbent position include special beds, overlay mattresses layered over a bottom mattress, and replacement mattresses to be substituted for conventional mattresses. Devices used for patients in a seated position include cushions placed on chairs and wheelchairs and pads used to adjust the body position. Materials used in body pressure-dispersion devices include air, water, urethane foam, gels and rubber. Wound bed preparation: Management of the wound surface environment to promote wound healing. Specifically, necrotic tissue is removed, bacterial load is reduced, drying of the wound is prevented, excessive exudates are controlled, and pockets and wound edges are treated. TIME: Practical principles of wound bed preparation based on the concept of evaluating factors that prevent wound healing from the viewpoints of tissue (T), infection or inflammation (I), moisture (M) and wound edge (E), and using the results for treatment and management Moist wound healing: Maintaining the wound surface in a moist environment. This retains polynuclear leukocytes, macrophages, enzymes and cell growth factors contained in exudates on the wound surface. Such an environment promotes autolysis and removal of necrotic tissues, and does not interfere with cell migration. Negative-pressure wound therapy (NPWT): A type of physical therapy. The wound is maintained in a closed environment and suction is applied to adjust the negative pressure of 125–150 mmHg. This therapy directly eliminates bacteria and exotoxins in the wound, promotes neovascularization in granulation tissue and alleviates edema. Pocket: A wound cavity larger than a skin defect. The tissue covering a pocket is called the cover wall or cover lid. Undermine. Washing: Removing chemical stimulants, infection sources and foreign bodies from the skin or wound surface using the pressure or lysing effect of a liquid. Washing may be performed using physiological saline, tap water or saline or tap water combined with a surfactant such as soap or detergent in a method known as washing with soap. The effect of washing may be derived from the flow volume or hydraulic pressure. Debridement: A therapeutic action to clean the wound by removing foreign material, necrotic tissue, senescent cells that no longer react to stimulation by promoters of wound healing such as growth factors, as well as foci of bacterial infection, which are often associated with the above. Methods include: (i) autolytic debridement induced by occlusive dressing; (ii) mechanical debridement (e.g. wet-to-dry dressing, high-pressure washing, hydrotherapy and ultrasonic washing); (iii) debridement using proteolytic enzymes; (iv) surgical debridement; and (v) biological debridement using maggots. Critical colonization: Conventionally, the microbial environment of the wound was classified into infected and aseptic states, but the current trend is to understand the two conditions as existing along a continuum (the concept of bacterial balance). Infection of the wound is understood as continuous stages of contamination, colonization and infection, and infection is considered to occur depending on the balance between the bacterial burden on the wound and host resistance. Critical colonization is a stage between colonization and infection when the balance has shifted toward infection and the number of bacteria has increased. Biofilm: Bacteria that have colonized the surface of a foreign body or in necrotic tissue may produce polysaccharides on their body surface. These gradually fuse and form a membrane-like structure, which envelops bacteria. This is called a biofilm. Bacteria wrapped in a biofilm are protected from ordinary antibiotics and leukocytes, and so infection is likely to persist. Seating: A supportive technique for using cushions and the like to provide a safe and comfortable seated position for the patient based on a physical evaluation taking into account the effect of gravity. It particularly refers to helping those patients who cannot sit upright to remain seated. The basic principles for the prevention, care and treatment of pressure ulcers are to avoid compression and shearing forces to the skin and protecting the wound surface. When a pressure ulcer has developed, the principle of treatment is “wound bed preparation” based on the TIME concept in the early, “black” and “yellow” stages. Achieving the good wound bed in “red” and “white” stages, “moist wound healing” will be intended. Note: The TIME concept is an acronym for “tissue” (treatment of non-viable or deficient tissue, that is management of necrotic/inactive tissue), “infection or inflammation” (control of infection or inflammation), “moisture” (correction of moisture imbalance, management of exudate) and “edge of wound” (treatment of non-advancing or undermined epidermal margin, management of the wound edge). Figures 1 and 2 show “the algorithm for diagnosis and treatment of pressure ulcers”, prepared based on the aforementioned concepts. The recommended and proposed treatments covered all the topical agents and dressing materials for injured skin, approved by the Japanese National Health Insurance Program, as well as surgical and physical treatments. While petroleum jerry-based antibiotic-containing ointments were approved for the treatment of erosion and ulcers by the Program, their use on deep pressure ulcers in the chronic phase may lead to the appearance of antibiotic-resistant bacterial strains; thus, the long-term use of those ointments should be avoided. Their use on the acute phase pressure ulcers or the chronic phase shallow ulcers, in expectation of the is including therapy and other not approved by the Japanese National Health Insurance Program, was also in this guideline, the present situation that it is performed at home under the 2 the as well as the level of recommendation and of the recommendation for ulcer or can a stage pressure ulcer be from using the method or the compression method is proposed as an Recommendation compression method The in diagnosis of as well as due to due to by or contact by an electric and chemical due to is Recommendation assessment of are for the assessment of for factors include the for home and the pressure ulcer evaluation presented by the of and Their appropriate use is recommended. Recommendation The use of and so is recommended to the skin and to prevent pressure ulcers. In the of a or the like to bone for the prevention of pressure ulcers is recommended. Recommendation foam, Nutritional support is recommended for the prevention and care of pressure ulcers. of and is recommended. Recommendation Nutritional support The use of a body pressure-dispersion and body position is recommended for the prevention of pressure ulcers their care as the use of a body pressure-dispersion and body position is recommended Recommendation Prevention Care of patients with pressure ulcers is recommended. Recommendation body pressure is proposed for and injury patients with pressure ulcers. Recommendation promote wound with the support team or a in nutritional is recommended for patients with or at of pressure ulcers and in a nutritional Recommendation The use of drugs such as and drugs body pressure-dispersion and dressing materials is proposed as for in pressure ulcers. Recommendation and body pressure-dispersion and dressing materials ulcers, acute treatments other than should be performed for pressure ulcers in the acute If dressing materials are to be used in the acute those that allow of the wound surface such as and are recommended. If topical agents are to be ointments such as and are recommended for protecting the wound and is recommended for use in the acute ointments antibiotics are proposed as an Recommendation and other antibiotics the diagnosis of deep tissue and blood are proposed as an Recommendation of the and course of the with is recommended dressing of the wound surface using dressing materials that allow of the such as a and dressings is recommended. Recommendation of the and course of the with decompression, and dressings pressure for the care of shallow pressure shallow pressure ulcers in the process of the use of is proposed as an Recommendation of the wound maintaining an appropriate moist environment is necessary for the of shallow pressure ulcers the level shallow Therefore, dressing materials often a in treatment. and are recommended. If topical agents are or is recommended for protecting the wound surface. ointments antibiotics and drugs such as and are recommended. Recommendation levels: Dressing materials: Topical agents: or other ointments drugs such as and pressure Treatment of early, “black” and “yellow” stage pressure Wound bed preparation based on the TIME concept Treatment of non-viable or deficient tissue surgical debridement for the removal of necrotic Surgical debridement of necrotic tissue is recommended if the patient's after the evaluation of Recommendation The use of and is recommended for removing necrotic tissue from deep pressure ulcers. necrotic tissue, the use of is recommended. dressing the use of is recommended. evidence is for and so not using it Wet-to-dry dressings also and so not using it Recommendation levels: tissue at a deep pressure ulcer: necrotic of infection or inflammation should infection of pressure ulcers be It is recommended to the of infection by evaluating of the ulcer and skin, the of inflammation of such as results of of the wound surface or the results of and blood Recommendation levels: of such as results of of the wound and blood of antibiotics is recommended not when bacterial from the ulcer surface are but also when of inflammation are in the skin the or when or of the is Recommendation The use of and is recommended for infection of pressure ulcers. there is no evidence for the use of an an it not be used Recommendation levels: dressing material when wound infection is the use