Wound healing society 2015 update on guidelines for venous ulcers

The Wound Healing Society (WHS) guidelines for the treatment of venous ulcers were originally published in 2006. These guidelines provided recommendations, along with their respective levels of evidence and strength on various categories. Over the past 7 years, a great deal of literature regarding these aspects of venous ulcer management has been published. An advisory panel comprised of academicians, clinicians, and researchers was chosen to update the 2006 guidelines. Members included vascular surgeons, internists, plastic surgeons, anesthesiologists, dermatologists, emergency medicine physicians, and registered nurses, all with expertise in wound healing. The goal of this article is to evaluate relevant new findings, on which an updated version of the guidelines will be based. In 2006, in an effort to develop guidelines that could provide clinicians with a reasonable approach to caring for patients, even in the absence of high quality human data, the WHS developed guidelines using a different approach to evidence citations and past approaches to evidence-based guidelines. Most past approaches relied only on publications regarding clinical human studies. Laboratory or animal studies were not cited. We have used well-controlled animal studies that present proof of principle, especially when a clinical series corroborated the laboratory results. Because of this variation, a different system was used to grade the weight of evidence supporting a given guideline. The strength of evidence supporting a guideline is listed as Level I, Level II, or Level III. Since the 2006 guidelines, we sought to capture the highest quality of literature available regarding venous leg ulcer diagnosis and treatment using a key word search of PubMed, Embase, and Cochrane Library databases. Similarly, the citations of relevant articles were examined by hand. Key terms were generated from the existing guidelines. In this search as opposed to the previous data collection prior to 2006, we used human and disease specific data and limited to meta-analyses, systematic reviews, RCTs, retrospective series reviews, clinical case series, and expert panel recommendations published between January 2006 and present. References prior to 2006 supporting the original guideline recommendations are not included. Therefore, in some cases no additional updated references were included and the support for the guideline recommendation is based on evidence presented in the 2006 guideline. Therefore, no updated references are presented. It was further limited to only English publications. Any relevant additional references found after the formal search were also included. The findings of these articles have been divided into one or more of the appropriate categories as performed in the original guideline. Each of the separate guidelines has undergone a Delphi consensus among the panel members. Not all panel members thought they had sufficient expertise to critique all of the separate sections of the guidelines. The first draft was of the guidelines was presented in 2014 for public comment and subsequent drafts revised based on those comments. Evidence Reference: Preamble: Ulcers of the lower extremity may be caused by a variety of conditions. Elevation of ambulatory venous pressure (venous hypertension) is the most common. However, as treatment of the ulcer may vary depending on ulcer etiology, it is paramount that a correct diagnosis is made before treatment. Guideline #1.1: Gross arterial disease should be ruled out by establishing that pedal pulses are present on physical examination and/or that the ankle: brachial index (ABI) is > 0.8. (Any ABI less than 1.0 suggests a degree of vascular disease and compression therapy is usually considered to be contraindicated with an ABI <0.7.) In elderly patients, patients with diabetes mellitus, or patients with an ABI >1.2, a toe: brachial index of > 0.6 or a trans-cutaneous oxygen partial pressure of >40 mmHg in the region of the ulcer may help to suggest an adequate arterial flow (Level I). Principle: Venous ulcers can exist in the presence of mixed arterial/venous pathology. Treatment of only the elevated venous pressure may not succeed when severe arterial disease is present. However, application of moderate amounts of compression may be successful in healing venous leg ulcers in patients with mild to moderate arterial insufficiency. Updated Evidence: Guideline #1.2: Many criteria have been used to identify a leg ulcer as a “venous” leg ulcer including clinical history and examination, invasive, and noninvasive testing. It is important to understand how the diagnosis was made and to understand the limitations of the method. Color duplex ultrasound scanning including both supine and standing positions to identify abnormal venous reflux and/or obstruction is useful in providing anatomic and physiologic data helping to confirm a venous etiology for the leg ulcer (Level II). Principle: Although clinical history and physical examination can be very suggestive of a venous etiology of the lower extremity ulcer after insufficient arterial inflow has been eliminated, a definitive diagnosis of the venous disease is desirable. This is not always possible. When using various tests to document venous disease, it is paramount that the information needed by the clinician be clearly communicated to the test performer. Updated Evidence: Guideline #1.3: Patients presenting with an apparent venous ulcer and who are suspected of having sickle cell disease should have a sickle cell prep and a hemoglobin electrophoresis (Level II). Principle: Patients with homozygous, heterozygous, or trait sickle cell hemoglobin can present with lower extremity ulcers resembling venous ulcers. Updated Evidence: None. Guideline #1.4: Apparent venous ulcers that have been open continuously without signs of healing for 3 months or that do not demonstrate any response to treatment after 6 weeks should be biopsied for histological diagnosis (Level III). Principle: Malignancy, vasculitis, collagen-vascular diseases, and dermal manifestations of systemic diseases may present as ulcers on the lower extremity. Updated Evidence: None. Guideline #1.5: Apparent venous ulcers, as well as all wounds, that are excessively painful and that progressively increase in size after debridement and/or despite treatment should be considered for other diagnoses such as pyoderma gangrenosum, IgA monoclonal gammopathies, Wegener's granulomatosis, cutaneous chronic granulomatous disease, and mycobacterial or fungal etiologies. This suspicion should be especially high if the ulcer is darker in color, has blue/purple borders, or if the patient has a systemic disease such as Crohn's disease, ulcerative colitis, rheumatoid arthritis, collagen vascular diseases, leukemia, or immunosuppression (Level II). Principle: Leg ulcers that worsen in size and symptoms despite treatment, or do not show any improvement over 4 weeks of treatment, should raise suspicion that the ulcer etiology is not venous in origin or that the therapy needs to be re-evaluated. At this point, specific cultures for mycobacteria and/or fungi are useful, as biopsies for histology. Updated Evidence: None. Preamble: Venous ulceration results from an elevated ambulatory venous pressure (venous hypertension). This frequently causes edema of the limb. External compression has been the mainstay to combat these problems. Guideline #2.1: The use of a Class 3 (most supportive) high-compression system is strongly recommended in the treatment of venous ulcers. High strength compression can be applied successfully using many methods including multilayered elastic compression, inelastic compression, Unna's boot, compression stockings, and other. Although these modalities are similar in effectiveness, they can differ significantly in comfort and cost. The degree of compression must be modified when mixed venous/arterial disease is confirmed during the diagnostic workup (Level I). Principle: Venous ulcer healing is increased when adequate compression is applied to the lower extremity. Updated Evidence: Guideline #2.2: Intermittent pneumatic pressure (IPC) can be used with or without compression dressings and can provide another option in patients who cannot or will not use an adequate compression dressing system (Level I). Principle: Intermittent pressure stimulates venous return and can be utilized when constant compression is not tolerated. Updated Evidence: Because venous hypertension is an ongoing condition, a degree of compression therapy should be continued constantly and forever. (see Long-Term Maintenance Guidelines.) Preamble: Infection results when the bacteria : host defense equilibrium is upset in favor of the bacteria. Infection plays various roles in the etiology, healing, operative repair, and complications of venous ulcers. Guideline #3.1: Remove all necrotic or devitalized tissue by sharp, enzymatic, mechanical, biological, or autolytic debridement (Level I). (Detailed discussion of debridement is in Wound Preparation Guidelines.) Principle: Necrotic tissue is laden with bacteria while devitalized tissue impairs the body's ability to fight infection and serves as a pabulum for bacterial growth. Updated Evidence: Guideline #3.2: If infection is suspected in a debrided ulcer, or if epithelialization from the margin is not progressing within 2 weeks of debridement and initiation of compression therapy, determine the type and level of infection in the debrided ulcer by tissue biopsy or by a validated quantitative swab technique (Level II). Principle: High levels of bacteria ≥1 × 106 CFU/g of tissue or any tissue level of beta hemolytic streptococci impede the various wound-healing processes and have been demonstrated to impede spontaneous healing and surgical closure of venous ulcers. Cultures should be performed to isolate both aerobic and anaerobic bacteria. Coordination with a laboratory medicine specialist is important to achieve useful results from wound cultures. Updated Evidence: (biopsies did not add prognostic information compared to analysis of surface microflora) Guideline #3.3: For ulcers with ≥ 1 × 106 CFU/g of tissue or any tissue level of beta hemolytic streptococci following adequate debridement, decrease the bacterial level with topical or systemic antimicrobial therapy. Once in bacterial balance, discontinue the use of the antimicrobial agent to minimize any possible cytotoxic effects due to the antimicrobial agent or emergence of bacterial resistance to the agent (Level II). Principle: Ulcers with high quantities of pathologic bacteria require treatment. In some cases it appears that topical antibiotics may be adequate to control levels and allow resumption of healing, but in other cases, particularly with resistant or biofilm-forming bacteria, systemic antibiotics may be necessary. Updated Evidence: Guideline #3.4: Cellulitis (inflammation and infection of the skin and subcutaneous tissue most commonly due to streptococci or staphylococci) surrounding the venous ulcer should be treated with systemic gram-positive bactericidal antibiotics (Level II). Principle: Edema fluid (plasma) neutralizes the fatty acids of sebum and inactivates the normal bactericidal properties of skin. This renders the skin and subcutaneous tissue susceptible to infection by streptococci and staphylococci. Updated Evidence: Guideline #3.5: Minimize the tissue level of bacteria, preferably to ≤105 CFU/g of tissue, with no beta hemolytic streptococci in the venous ulcer before attempting surgical closure by skin graft, skin equivalent, pedicled, or free flap (Level II). Principle: “A wound containing contaminated foci with greater than 105 organisms per gram of tissue cannot be readily closed, as the incidence of wound infection that follows is 50–100%” Updated Evidence: None. Aspects of wound bed preparation are deliberately left out of this section because they are covered elsewhere. (Detailed discussions of infection control, dressings, and tissue engineering/growth factors are in Infection Control Guidelines, Dressings Guidelines, and Adjuvant Agents [Topical, Device, and Systemic] Guidelines.) Preamble: Wound bed preparation is defined as the management of the wound to accelerate endogenous healing or to facilitate the effectiveness of other therapeutic measures. The aim of wound bed preparation is to convert the molecular and cellular environment of a chronic wound to that of an acute healing wound. The principles of wound bed preparation have been enumerated: Guideline #4.1: Examination of the patient as a whole is important to evaluate and correct causes of tissue damage. This includes factors such as: (A) systemic diseases and medications, (B) nutrition, and (C) tissue perfusion and oxygenation (Level II). Principle: (A) A general medical history and physical examination, including a medication record, will help in identifying and correcting systemic causes of impaired healing. The presence of a major illness or systemic disease and drug therapies such as immunosuppressive drugs and systemic steroids will interfere with wound healing by alterations in immune functioning, metabolism, inflammation, nutrition, and tissue perfusion. Autoimmune diseases such as rheumatoid arthritis, vasculitis, or pyoderma can all healing and may require systemic steroids or immunosuppressive before wound healing can Patients major have a wound-healing as do chronic This information in to a history of the wound is of Updated Evidence: None. Principle: (B) must be adequate to provide sufficient to support the of Although most venous ulcer patients are ambulatory and not as as patients who require or chronic support is if an is Updated Evidence: None. Principle: (C) require adequate oxygenation and perfusion to provide an environment that will support normal healing. to a wound will be impaired if tissue perfusion is and factors that increase such as or will all decrease tissue perfusion. tissue oxygen by For tissue these factors must be or Updated Evidence: None. Guideline debridement is to the necrotic tissue, bacterial and cellular of and Maintenance debridement is needed to the and of the wound bed for healing. The can from a of debridement methods including sharp, enzymatic, mechanical, biological, or than one debridement may be appropriate (Level II). Principle: Necrotic tissue, bacterial and cellular can all wound healing. debridement is the most However, the of debridement chosen may on the of the the of the the of the and debridement can in a of the with a of Updated Evidence: Guideline should be and dressing using a wound should be with a of and/or (Level III). Principle: and the wound to wound healing. or is usually should only be used if the is data suggest that a may be useful as may fluid by increased Updated Evidence: None. Guideline should be an ongoing and of wound and of the surrounding and to evaluate wound bed The of wound healing should be to determine treatment is (Level I). Principle: of wound bed preparation are because if the ulcer is not healing the for wound bed preparation to be The the of the ulcer, the more it is to If an ulcer is patient or of and to be Updated Evidence: None. Preamble: is a of for topical treatment of venous ulcers. Many dressings wound bed that debridement and/or antimicrobial with are to help the clinician regarding the and use of these wound Most dressings will be used in with compression (see Guideline a dressing that will a wound-healing environment (Level I). Principle: A wound environment cell and while healing of by autolytic wound healing also dressings, over are considered and can of the wound. Updated Evidence: None. Guideline clinical to a wound dressing that continued (Level I). Principle: dressings are not considered continuously dressings are as as other of wound healing in terms of healing they may have other such as of the of and It can also be very to dressings continuously Updated Evidence: None. Guideline a dressing that will the wound and the skin (Level I). Principle: and with wound can the wound and impede healing. Updated Evidence: Guideline a dressing that in and and not additional tissue (Level II). Principle: Wound skin and patient can all the of The use of compression for venous ulcers the for to the dressing in However, additional tissue may if the dressing causes increased pressure on the wound or Venous ulcer patients are particularly susceptible to to topical Updated Evidence: None. Guideline a dressing that is and appropriate to the and the (Level I). Principle: Because of their dressings are as the most However, as out in Guideline it is very to a dressing continuously When effectiveness, it is important to into of and healing as well as the of the Updated Evidence: Guideline use and/or after and when is a of healing in response to more If wound improvement not within weeks of a treatment of the patient and of other treatment should be (Detailed discussions of these are in Adjuvant Agents [Topical, Device, Systemic] Level Principle: therapies and may and increase healing in patients or These therapies are and are in in the Adjuvant Agents Updated Evidence: evidence references are in the Adjuvant Agents Device, Preamble: The of wound dressings and a compression system are not successful in healing all venous ulcers. they do not the etiology of increased ambulatory venous Over the years, surgical have been to venous ulcers with of clinical operative are in the but data are available supporting in These data a Venous a from to operative treatment. Guideline of a venous ulcer, without to the venous disease, is not a and is to leg ulceration (Level I). Principle: the venous ulcer with an skin graft, graft, graft, may provide a goal of wound closure but not the increased ambulatory venous pressure (venous hypertension) that is the of the use of compression therapy after skin is important to achieve ulcer healing. Updated Evidence: Guideline venous Updated Evidence: Updated Evidence: Guideline venous obstruction We of chronic obstruction with venous ulcers that are to therapy. (Level Principle: Patients with severe obstruction of the venous are to compression therapy due to venous in healing with compression therapy. of the venous the ability of compression to venous hypertension and and other symptoms in patients with severe chronic venous Patients not to compression and other should ultrasound or other to evaluate for this Updated Evidence: Guideline flap with can venous ulcers with severe by of tissue and providing venous in the tissue (Level II). Principle: tissue from a region of the can tissue with to an of Updated Evidence: None. Preamble: Many have been for use as to wound-healing dressings and compression therapy in the treatment of venous ulcers. These can be divided into topical to be applied to the ulcer, ulcer healing, and systemic drugs to the of these have evidence to allow guidelines regarding their use to be Guideline factors have to be to demonstrate sufficient results of effectiveness to any of for treatment of venous ulcers, suggest their (Level I). Principle: factors are of the wound-healing have been to be or in chronic wounds, they could be useful for treatment of venous ulcers, and have results in Updated Evidence: None. Guideline application of free have been to be for treatment of venous ulcers, as has a topical of these modalities have sufficient data to their use (Level I). Principle: by free has been to a in the etiology of venous ulcers. is also an important of venous Therefore, to decrease or these effects could be useful Updated Evidence: None. Guideline is evidence that a human cellular used in with compression the incidence of healing and of healing for venous ulcers compared with compression and a dressing (Level I). Principle: skin or dressings are that provide wound closure and as a of for healing of venous ulcers. of a cellular made using and was found to significantly more than compression in a clinical We that prior to the application of any adequate wound bed preparation should be including of and any necrotic tissue We also to control of levels prior to the application of a cellular therapy. Updated Evidence: None. Guideline or have not been demonstrated to healing of venous ulcers (Level I). Principle: Although have been useful in they do not to be to be on venous leg ulcers. Updated Evidence: None. is evidence that a may healing of venous ulcers. (Level Principle: tissue are available for use in chronic that human tissue or animal tissue are to factors or other that be to healing venous leg ulcers. the of such only has data supporting to accelerate venous ulcer Updated Evidence: None. Guideline may be useful in the size of venous leg ulcers (Level I). Principle: methods of have been to wound healing in many Not data exist to determine the should be high or and or is Updated Evidence: None. Guideline pressure wound therapy may be useful prior to a skin by helping the of tissue in the wound or by and However, in venous ulcers is limited (Level II). Principle: pressure wound therapy pressure to help in tissue decrease wound and help skin Updated Evidence: None. Guideline therapy can be considered when wound healing to after 4 weeks of of The ultrasound and treatment are not well (Level III). Principle: is insufficient evidence to the use of therapeutic ultrasound for the treatment of venous leg ulcers as a therapy. It should be that ultrasound has healing in compared with therapy. The of treatment therapy or to determine the of this publications a of ultrasound therapy for chronic and a on venous a of therapeutic ultrasound performed in the utilized a of ultrasound to allow for this no was over therapy that this must be used to provide a healing Updated Evidence: Guideline therapy, and ultrasound therapy have not been to venous ulcer healing (Level I). Principle: are and studies that modalities such as therapy, and ultrasound therapy be useful in the treatment of venous ulcers. evidence not support their Updated Evidence: None. Guideline may be useful as an to compression therapy in the treatment of venous ulcers (Level III). Principle: may be similar to surgical when used with an adequate compression may ulcer treatment. Updated Evidence: None. Guideline used in with compression therapy healing of venous ulcers (Level I). Principle: to the of the leg should the healing processes of venous ulcers. Updated Evidence: None. Guideline The of or in the treatment of venous ulcers sufficient data to allow a recommendation (Level II). Principle: and effects of such as or could venous and minimize Updated Evidence: None. Guideline treatment with may be a useful to compression therapy in the treatment of leg ulcers (Level I). Principle: Agents that of and free oxygen decrease and and should in the healing of venous ulcers. Updated Evidence: Guideline with an such as in with compression therapy may be useful in with venous ulcers. However, one must be of effects (Level II). Principle: A agent of should be to decrease and in cases of Updated Evidence: None. Guideline is not useful in the treatment of venous leg ulcers (Level I). Principle: to patients without a will not healing of chronic such as venous ulcers. Updated Evidence: None. Preamble: Venous ulcers of the lower extremity are a are as high as Therefore, must be even for ulcers. Guideline Patients with or venous ulcers should use compression constantly and (Level I). Principle: Most do not the increased ambulatory venous pressure (venous a degree of compression is The of compression that should be applied is In a moderate grade compression to a level patients who used their compression had a lower of ulcer of they used the level of compression, but significantly patients were to use the level Updated Evidence: Guideline to increase have been demonstrated to be in and venous ulcer (Level III). Principle: has been to be with Updated Evidence: