NTR1849 (http://www.trialregister.nl).
For some wound care interventions, robust evidence exists upon which clinical decisions should be based.
Significance: Large variation and many controversies exist regarding the treatment of, and care for, acute wounds, especially regarding wound cleansing, pain relief, dressing choice, patient instructions, and organizational aspects. Recent Advances: A multidisciplinary team developed evidence-based guidelines for the Netherlands using the AGREE-II and GRADE instruments. A working group, consisting of 17 representatives from all professional societies involved in wound care, tackled five controversial issues in acute-wound care, as provided by any caregiver throughout the whole chain of care. Critical Issues: The guidelines contain 38 recommendations, based on best available evidence, additional expert considerations, and patient experiences. In summary, primarily closed wounds need no cleansing; acute open wounds are best cleansed with lukewarm (drinkable) water; apply the WHO pain ladder to choose analgesics against continuous wound pain; use lidocaine or prilocaine infiltration anesthesia for wound manipulations or closure; primarily closed wounds may not require coverage with a dressing; use simple dressings for open wounds; and give your patient clear instructions about how to handle the wound. Future Directions: These evidence-based guidelines on acute wound care may help achieve a more uniform policy to treat acute wounds in all settings and an improved effectiveness and quality of wound care. SCOPE AND SIGNIFICANCEFor chronic wounds, such as venous, arterial, pressure, and diabetic foot ulcers, several (inter)national guidelines are available. 1 For wounds with an acute etiology, fewer guidelines exist. Still, an undesirable inconsistency in wound care practice is evident from the huge number of wound dressings available, the large number of caregivers involved, and the many opinions regarding optimum wound care. 2 This calls for more evidence-based and more uniform care to avoid undesired variation in care. TRANSLATIONAL RELEVANCEIn terms of translational research, available guidelines have focused on diminishing barriers for wound healing given certain comorbid conditions, 3 or have described inconsistencies in the documentation of surgical wound care according to existing guidelines, mainly regarding the prevention and treatment of surgical site infections, which hamper interdisciplinary communication. 4 CLINICAL RELEVANCECurrent clinical guidelines on acute wound care comprise the CDC
In wound care research, available high-level evidence according to the evidence pyramid is rare, and is threatened by a poor study design and reporting. Without comprehensive and transparent reporting, readers will not be able to assess the strengths and limitations of the research performed. Randomized clinical trials (RCTs) are universally acknowledged as the study design of choice for comparing treatment effects. To give high-level evidence the appreciation it deserves in wound care, we propose a step-by-step reporting standard for comprehensive and transparent reporting of RCTs in wound care. Critical reporting issues (e.g., wound care terminology, blinding, predefined outcome measures, and a priori sample size calculation) and wound-specific barriers (e.g., large diversity of etiologies and comorbidities of patients with wounds) that may prevent uniform implementation of reporting standards in wound care research are addressed in this article. The proposed reporting standards can be used as guidance for authors who write their RCT, as well as for peer reviewers of journals. Endorsement and application of these reporting standards may help achieve a higher standard of evidence and allow meta-analysis of reported wound care data. The ultimate goal is to help wound care professionals make better decisions for their patients in clinical practice.In the present era of evidence-based medicine, the use of best available evidence has become an essential part of clinical decision making to ensure and improve quality of care. The requirements to meet this hunger for evidence are the following: first, a proper design and conduct of studies rendering convincing evidence, and second a clear and concise, but at the same time comprehensive and unbiased, description of the conducted research to show the validity of the study and the effect of the intervention investigated.In wound care research, available high-level evidence according to the evidence pyramid 1 is rare, and is threatened by either a poor study design or inconclusive results. [2][3][4][5][6] Nevertheless, the number of scientific publications in wound care shows a 30-fold increase over the last five decades. 7During this period, numerous guidelines and recommendations have been developed to improve the quality of design and conduct of wound care research. 3,5,8 Unfortunately, upgrading the quality of a study design does not automatically improve the quality of reporting in wound care publications. 4,9-11 First, positive study results tend to be published more often than indifferent or negative study results, known as publication bias. Second, adverse events may be neglected or reported selectively (also known as reporting bias, caused by the researchers). Third, the nomenclature of essential terms or presentation of the results may differ from other publications in similar areas.6,12-15 These sources of bias emphasize the need for full and transparent reporting of wound care research, which will allow readers to assess the strengths and limitations o...
The care for chronic and acute wounds is a substantial problem around the world. This has led to a plethora of products to accelerate healing. Unfortunately, the quality of studies evaluating the efficacy of such wound care products is frequently low. Randomized clinical trials are universally acknowledged as the study design of choice for comparing treatment effects, as they eliminate several sources of bias. We propose a framework for the design and conduct of future randomized clinical trials that will offer strong scientific evidence for the effectiveness of wound care interventions. While randomization is a necessary feature of a robust comparative study, it is not sufficient to ensure a study at low risk of bias. Randomized clinical trials should also ensure adequate allocation concealment and blinding of outcome assessors, apply intention-to-treat analysis, and use patient-oriented outcomes. This article proposes strategies for improving the evidence base for wound care decision making.
BackgroundThe decision to discharge a patient from a hospital is a complex process governed by many medical and non-medical factors, while the actual reasons for discharge frequently remain ill-defined.AimTo define relevant discharge criteria as perceived by doctors, nurses and patients for the development of a standard hospital discharge policy, we collected actual reasons and most pivotal medical and organisational criteria for discharge among all stakeholders.SettingA tertiary referral university teaching hospital.MethodsWe conducted a mixed methods analysis, using patient questionnaires, interviews and a focus group with caregivers, and observations during the daily rounds of doctors, nurses and patients during their hospital stay. Fourteen wards of the Surgery, Paediatrics and Neurology departments contributed.ResultsWe observed 426 patients during their hospital stay. Forty doctors and nurses were interviewed, and 7 senior nurses attended a focus group. The most commonly used discharge criteria were clinical factors, organisational discharge issues and patient-related factors. A total of 269 patients returned their questionnaires. About one third of the adult patients and nearly half of the children (or their parents) felt their personal situation and assistance needed at home was insufficiently taken into account before discharge. Patients were least satisfied with the information given about what they were allowed to do or should avoid after discharge and their involvement in the planning of their discharge. Thus, besides obvious medical reasons for discharge, several non-medical reasons were signalled by all stakeholders as important issues to be improved.ConclusionsA set of discharge criteria could be defined that is useful for a more uniform hospital discharge policy that may help reduce unnecessary length of stay and improve patient satisfaction.
BackgroundDonor site wounds after split-skin grafting are rather 'standard' wounds. At present, lots of dressings and topical agents for donor site wounds are commercially available. This causes large variation in the local care of these wounds, while the optimum 'standard' dressing for local wound care is unclear. This protocol describes a trial in which we investigate the effectiveness of various treatment options for these donor site wounds.MethodsA 14-center, six-armed randomized clinical trial is being carried out in the Netherlands. An a-priori power analysis and an anticipated dropout rate of 15% indicates that 50 patients per group are necessary, totaling 300 patients, to be able to detect a 25% quicker mean time to complete wound healing. Randomization has been computerized to ensure allocation concealment. Adult patients who need a split-skin grafting operation for any reason, leaving a donor site wound of at least 10 cm2 are included and receive one of the following dressings: hydrocolloid, alginate, film, hydrofiber, silicone dressing, or paraffin gauze. No combinations of products from other intervention groups in this trial are allowed. Optimum application and changes of these dressings are pursued according to the protocol as supplied by the dressing manufacturers. Primary outcomes are days to complete wound healing and pain (using a Visual Analogue Scale). Secondary outcomes are adverse effects, scarring, patient satisfaction, and costs. Outcome assessors unaware of the treatment allocation will assess whether or not an outcome has occurred. Results will be analyzed according to the intention to treat principle. The first patient was randomized October 1, 2009.DiscussionThis study will provide comprehensive data on the effectiveness of different treatment options for donor site wounds. The dressing(s) that will prevail in effectiveness, satisfaction and costs will be promoted among clinicians dealing with such patients. Thus, we aim to contribute a well-designed trial, relevant to all clinicians involved in the care for donor site wounds, which will help enhance uniformity and quality of care for these patients.Trial registrationhttp://www.trialregister.nl, NTR1849. Date registered: June 9, 2009
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