This document sets out to understand the prevalence of various health and chronic illness risk factors among those with chronic wounds and how those factors influence healing.
Part 1 provides background information on population health and identifies the risk factors for chronic illnesses that are the focus of this document. Factors including stress, sleep, smoking, medication, illicit drug use and alcohol consumption are explored, all commencing with an understanding of pathophysiology as it relates to wound healing, followed by a review of the literature as it applies to chronic wounds. Evidence of interventions at the level of randomised controlled trials (RCTs) to manage these factors and their impact on wound prevention or treatment is limited and thus we will refer to systematic reviews, observational studies and in vitro studies as appropriate.
Archives
TLC-Ag dressings a prospective, multicentre study on 728 patients with wounds at risk of or with local infection
Objective:This study aimed to evaluate the management of an unselected cohort of patients with wounds at risk of or with clinical signs of local infection, treated with two antimicrobial contact layers impregnated with silver (TLC-Ag healing matrix), under real-life conditions during the COVID-19 pandemic.
Method:A large, prospective, multicentre, observational study with two TLC-Ag dressings (UrgoTul Ag/Silver and UrgoTul Ag Lite Border, Laboratoires Urgo, France) was conducted in Germany between May 2020 and May 2021. The main outcomes included a description of the treated patients and their wound management, the changes in wound infection and wound healing outcomes over a maximum period of four weeks of treatment, as well as the overall clinical assessment of the performance, local tolerance and acceptability of dressings.
Results:A total of 728 patients with wounds of various aetiologies and wound infection status were treated with the evaluated dressings in 39 centres for a mean duration of 26±19 days, with an intermediate visit conducted in 712 (97.8%) patients after a mean period of 12±9 days. At the initial visit, it was established that the majority of patients (60.4%) had a wound infection, while the remaining cohort presented first clinical signs of a local wound infection (25.1%) or were at risk of wound infection (13.2%) (unclear status in 1.2%). Throughout the study period, all the parameters of wound infection continuously decreased, resulting at the final visit in a reduction by 78.9% of the prevalence of local wound infections and by 72.0% of the clinical signs of wound infection, the most rapidly diminished clinical sign being wound deterioration. Concurrently, in terms of the healing process, 92.1% of the wounds healed or improved, 3.2% remained unchanged and 1.7% worsened (data missing for 3.0%), and an improvement of the periwound skin was reported in 65.7% of the patients. Overall, the two dressings were ‘very well accepted’ by the majority of patients, with no uncomfortable feeling at wearing and no pain at dressing removal, and were assessed by the physicians as ‘very useful’ in the majority of the cases with a ‘very good’ efficacy in terms of antimicrobial activity and promotion of the wound healing process. Similar results were reported regardless of the wound type treated or of the TLC-Ag dressing evaluated.
Conclusion:These results are consistent with previous clinical evidence on TLC-Ag dressings. They support the good efficacy, good tolerability and usefulness of these antimicrobial dressings in the management of patients with wounds at risk or with clinical signs of local infection, in association with appropriate standard of care.
The Impact of Patient Health and Lifestyle Factors on Wound Healing, Part 2 Physical Activity and Nutrition
Part two of the EWMA document ‘The impact of patient health and lifestyle factors on wound healing’ focuses on two factors: physical activity and nutrition. In this paper, the pathophysiological understanding of how physical activity and nutrition either increase the risk for wounding or impact the healing process will be presented. We review current evidence for the effectiveness of interventions in improving healing outcomes and offer some recommendations for practice and further research. This part of the document should be read in conjunction with Part 11, which discussed stress, sleep, smoking, illicit drug use and alcohol misuse and described how some commonly used medications impact the healing process.
Evaluation of the Nanooligosaccharide Factor Lipido-Colloid Matrix in the Local Management of Venous Leg Ulcers Results of a Randomised, Controlled Trial
The nano-oligosaccharide factor (NOSF) is a new compound aiming to promote wound closure mainly through inhibition of matrix metalloproteinase (MMP) activity. This factor is incorporated within a lipido-colloid matrix (Techonology Lipido-Colloid-NOSF matrix) and locally released in the wound. The objective of this study was to document the performance (non inferiority or superiority) of the NOSF relative to the Promogran® matrix (oxidised regenerated cellulose, ORC) effect in the local management of venous leg ulcers (VLUs). This was a 12-week, open, two-arm, multicentre, randomised study. Patients were selected if the area of their VLU [ankle brachial pressure index ≥ 0.80] ranged from 5 to 25 cm2 with a duration≥3 months.
Ulcers had to be free from necrotic tissue. In addition to receiving compression bandage therapy, patients were randomly allocated to either NOSF matrix or ORC treatment for 12 weeks. The VLUs were assessed on a weekly basis and wound tracings were recorded. Percentage wound relative reduction (%RR) was the primary efficacy criterion. Secondary objectives were wound absolute reduction (AR), healing rate (HR) and % of wounds with≥ 40% reduction compared with baseline. A total of 117 patients were included (57 NOSF matrix and 60 ORC). Mean population age was 71.3 ± 13.5 years, body mass index was ≥ 30 kg/m2 in 39.3% and 15.4% were diabetics. Fifty-six per cent of the VLUs were present for >6 months, 61% were recurrent and 68%were stagnating despite appropriate care. Mean wound area at baseline was 11.2 ± 7.4 cm2. At the last evaluation, mean difference between the groups for %RR was 33.6 ± 15.0% in favour of NOSF matrix with a unilateral 95% confidence interval (CI) lower limit of 8.6% not including the null value. Therefore, a superiority of NOSF matrix effect compared with ORC was concluded (P= 0.0059 for superiority test). The median of the wound area reduction was 61.1% and 7.7% in the NOSF matrix and control groups, respectively (per-protocol analysis), or 54.4% versus 12.9% in intent-to-treat analysis (p =0.0286). Median AR was 4.2 cm2 in the NOSF group and 1.0 cm2 with ORC (P = 0.01). Median HR was -0.056 and -0.015 cm2/day in NOSF and ORC groups, respectively (P = 0.029). By logistic regression, the NOSF versus control odds ratio to reach 40% area reduction was 2.4 (95% CI: 1.1 – 5.3; P = 0.026). In the oldest and largest VLUs, a strong promotion of healing effect was particularly observed in the NOSF matrix group compared with the control group. NOSF matrix is a very promising option for the local management of chronic wounds, especially for VLUs with poor healing prognosis.
World Union of Wound Healing Societies Evidence in Wound Care
Wound management research improves patient care and clinical
outcomes by standardising assessment, planning and implementation
of treatment. In the field of wound care, high-level evidence is
possible, but it can be difficult to conduct due to the wide-ranging
nature of wounds and patients.
Additionally, there is an ever-growing variety of products and devices available to practitioners to improve healing rates and patient outcomes. In many cases, these products have enabled practitioners to heal more complex wounds and manage more
challenging and difficult cases. However, practitioners must be able to critically appraise evidence to make appropriate and effective evidence-based changes to practice.
UrgoStart Plus in Real Life
The prevalence of patients with chronic wounds continues to grow year-on-year and this places a substantial burden on health care resources. It is estimated that the NHS treats more than 2.2 million wounds annually, equating to 4.5% of the adult population, and the total cost of managing these wounds and associated co-morbidities is calculated to be £5.3 billon per year (Guest et al, 2015). However, it has been recognised that there are considerable unwarranted
variations in wound care services across the UK and that standardising practices offers opportunities to improve healing rates, reduce patient suffering and provide cost efficiencies
(NWCSP, 2020). In 2019 the National Institute for Health and Care Excellence published medical technologies guidance in relation to the UrgoStart treatment range. The committee reviewed five empirical
research papers, three of which were randomised controlled clinical trials. The committee critically appraised the publications and concluded that there was evidence to support the case
for adopting the UrgoStart treatment range to treat patients with diabetic foot ulcers and venous leg ulcers in the NHS, as the use of the UrgoStart treatment range was found to be associated
with increased rates of wound healing when compared with non-interactive dressings. Furthermore, they suggested that using the UrgoStart treatment range as part of the overall
management of diabetic foot ulcers and venous leg ulcers could reduce costs for the NHS.
Evaluation of NOSF in Neuropathic Diabetic Foot Ulcers
Both case studies feature neuropathic patients who have good lower limb arterial blood flow and there is an expectancy these wounds will heal. However, it is the speed of healing that is interesting, as well as the fact
that these wounds were progressed from a non/slow-healing state into a healed state. Of particular interest is the fact that Case Study 1 healed without the use of adequate pressure relief (the patient was non-compliant with the use of an Aircast boot). Pressure relief is an integral part of wound healing (NICE, 2004) and this factor alone could have been the cause of non-healing. Since the wound healed despite pressure relief not being adequate, this would indicate that, in this case, Urgostart Contact dressing was effective.UrgoStart Contact can be used effectively in the management of neuropathic diabetic foot wounds, however, the author has not been involved in case studies that demonstrate its effectiveness on diabetic neuroischaemic wounds.
Use of Nano-Oligosaccharide Factor (Sucrose Octasulfate) Dressing Based on Technology Lipido-Colloid (TLC-NOSF) as an Interface Layer with Negative Pressure Wound Therapy
Complex and complicated wounds (CCWs) tend to exhibit slow wound healing and poor prognoses despite good standards of care. Numerous literature demonstrated the efficacy of TLC-NOSF dressing (UrgoStart®) in healing of both acute and chronic wounds. The author thus hypothesised that inclusion of TLC-NOSF dressing in dressing regimes would enhance wound healing and improve outcomes in CCW. This paper successfully verifies the hypothesis on three such
wounds, with good wound healing outcomes achieved.
Diabetic Foot Ulcer Management with TLC-NOSF (Technology Lipido-Colloid Nano-Oligosaccharide Factor) Wound Dressings from China
Diabetes and its associated complications is one of the biggest burdens that healthcare providers face. Diabetic foot ulcers (DFUs) are difficult-toheal wounds resulting from the diabetes-related pathogenic abnormalities.
Statistics from China are high, with the largest global prevalence of people with diabetes, and the local expenditure for this disease is second only to the US (Zhang et al, 2021). Moreover, 20% to 33% of costs related to diabetes mellitus are used for treatments of the diabetic foot (Chun et al, 2019). International and Chinese national guidelines broadly agree on the standard of care for the management of diabetic foot ulcers and it is very well understood that evidence-based holistic management, including local wound dressings, can improve healing outcomes. The clinical cases portrayed are aimed at describing the attainment of the implementation of Technology-Lipido-Colloid Nano-Oligosaccharide Factor dressing (TLC-NOSF). The TLC-NOSF dressing has been included in recent recommendations by the International Working Group on the Diabetic Foot (IWGDF) 2019 Guidelines and the National Institute for Health and Care Excellence (NICE, UK) and was the focus of a recently published systematic review highlighting the robust evidence behind this technology
Australian Guideline on Wound Healing Interventions to Enhance Healing of Foot Ulcers Part of the 2021 Australian Evidence-Based Guidelines for Diabetes Related Foot Disease
Abstract
Background: Diabetes-related foot ulceration (DFU) has a substantial burden on both individuals and healthcare systems both globally and in Australia. There is a pressing need for updated guidelines on wound healing interventions to improve outcomes for people living with DFU. A national expert panel was convened to develop new Australian evidence-based guidelines on wound healing interventions for people with DFU by adapting suitable international guidelines to the Australian context.
Methods: The panel followed National Health and Medical Research Council (NHMRC) procedures to adapt suitable international guidelines by the International Working Group of the Diabetic Foot (IWGDF) to the Australian context. The panel systematically screened, assessed and judged all IWGDF wound healing recommendations using ADAPTE and GRADE frameworks for adapting guidelines to decide which recommendations should be adopted, adapted or
excluded in the Australian context. Each recommendation had their wording, quality of evidence, and strength of recommendation re-evaluated, plus rationale, justifications and implementation considerations provided for the Australian context. This guideline underwent public consultation, further revision and approval by ten national peak bodies.