Archives

Evaluation of a Lipido-Colloid Wound Dressing in the Local Management of Leg Ulcers

Objective: To evaluate the efficacy, tolerance and acceptability of Urgotul and DuoDERM E dressings
in the local management of venous or mixed-aetiology leg ulcers.
l Method: This was a prospective multicentre randomised phase IV clinical trial conducted open-label
in parallel groups. It involved 20 investigating centres, including hospital dermatology and vascular
medicine departments, and private practices. Dermatologists and angiologists/phlebologists took part.
Subjects were adult, non-immunosuppressed patients presenting with a non-infected, non-malignant leg
ulcer of predominantly venous origin (ABPI >0.8). Ulcers were between 4cm2 and 40cm2 in size, with
granulation tissue covering more than 50% of their surface area. Ulcer duration ranged from three to
18 months. Patients were followed-up by the investigating physician for eight weeks on a weekly basis;
this included clinical examination, wound area tracings and photographs. Nurses (hospital or visiting)
assessed exudate volume and clinical appearance at dressing changes.
l Results: Ninety-one patients were included: 47 in the Urgotul group and 44 in the DuoDERM E
group. Baseline patient demographic data and wound characteristics were comparable in the two groups.
After eight weeks of treatment wound surface area had reduced by a mean of 61.3% in the Urgotul
group and 52.1% in the DuoDERM E group (NS); dressings were changed more frequently in the
DuoDERM E group (2.54 ± 0.57 times per week versus 2.31 ± 0.45 in the Urgotul group, p=0.047).
Thirty-three local adverse events were recorded in 27 patients: 10 in the Urgotul group and 23 in the
DuoDERM E group (p=0.039). Nurses reported better acceptability for the Urgotul dressing, based on
pain on removal, maceration and odour (p<0.0001).
l Conclusion: Both dressings showed similar efficacy for the local treatment of venous leg ulcers.
Nevertheless, medical and nursing staff reported better tolerance and acceptability for the
Urgotul dressing.

Using Urgotul Dressing for the Management of Epidermolysis Bullosa Skin Lesions

l Objective: To evaluate the acceptability, tolerance and efficacy of Urgotul wound dressing in the
management of epidermolysis bullosa (EB) skin lesions.
l Method: This was an open-label uncontrolled clinical trial involving 20 patients (11 adults and nine
children) with EB simplex or dystrophic EB. Patients were selected from the register of EB patients at
the investigating centre and included if they presented with at least one skin lesion requiring
management with a non-adherent wound dressing. Lesions were treated with the study dressing for a
maximum of four weeks. All dressing changes, wound parameters, pain and effect on quality of life were
recorded.
l Results: All patients completed the trial. Nineteen out of 20 wounds healed within 8.7 ± 8.5 days.
Overall, 11 patients (55%) considered that their quality of life had improved following use of the dressing,
which was also reported to be pain free and ‘very easy’ or ‘easy’ to remove at most dressing changes.
Nineteen out of 20 patients stated that they would use the study dressing to manage their lesions
in future.
l Conclusion: This study confirmed the very good acceptability and efficacy of Urgotul in the
treatment of skin lesions in patients with EB.

Practical Guidelines on the Prevention and Management of Diabetes-Related Foot Disease IWGDF 2023 Update

Diabetes-related foot disease results in a major global burden for patients and the healthcare system. The International Working Group on the Diabetic Foot (IWGDF) has been producing evidence-based guidelines on the prevention and management of diabetes-related foot disease since 1999. In 2023, all IWGDF Guidelines have been updated, based on systematic reviews of the literature and formulation of recommendations by multidisciplinary experts from all over the world. In addition, a new guideline on acute Charcot neuro-osteoarthropathy was created. In this document, the IWGDF Practical Guidelines, we describe the basic principles of prevention, classification and management of diabetes-related foot disease, based on the seven IWGDF Guidelines. We also describe the organizational levels to successfully prevent and treat diabetes-related foot disease according to these principles and provide addenda to assist with foot screening. The information in these practical guidelines is aimed at the global community of healthcare professionals who are involved in the care of persons with diabetes. Many studies around the world support our belief that implementing these prevention and management principles is associated with a decrease in the frequency of diabetes-related lower-extremity amputations. The burden of foot disease and amputations is increasing at a rapid rate, and comparatively more so in middle to lower income countries. These guidelines also assist in defining standards of prevention and care in the these countries. In conclusion, we hope that these updated practical guidelines continue to serve as a reference document to aid healthcare providers in reducing the global burden of diabetes-related foot disease.

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.

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

A Prospective Study on the Efficacy of Sequential Treatment of Technology Lipido‐Colloid Impregnated with Silver and Technology Lipido‐Colloid Nano‐Oligosaccharide Factor in the Management of Venous Leg Ulcers

Background and Aims: Venous leg ulcers (VLUs) are associated with significant morbidity and poor quality of life (QOL). Compression therapy and wound dressing are the mainstay treatment options. Technology Lipido‐Colloid Impregnated with Silver (TLC‐Ag) reduces bacterial load and Technology Lipido‐Colloid Nano‐Oligosaccharide Factor (TLC‐NOSF) reduces elevated matrix metalloproteinases and improve wound healing. However, evidence is scarce on the role of sequential therapy. This study aims to evaluate if sequential treatment with TLC‐Ag and TLC‐ NOSF improves VLU wound healing and QOL.
Methods: This is a prospective cohort study from May 2020 to October 2021 on patients with VLUs who received sequential therapy, consisting of 2 weeks of TLC‐Ag followed by two‐layer compression bandage (2LB) with TLC‐NOSF until complete wound healing. Participants were followed‐up with weekly dressing changes. Our primary outcomes were wound area reduction (WAR) and Pressure Ulcer Scale of Healing (PUSH) score. Our secondary outcomes were QOL measures.
Results: There were 28 patients with 57.1% males (n = 16) with a mean age of 65.3 years. Mean duration of VLU was 13.9 ± 11.7 weeks before the initiation ofsequential therapy. Mean baseline wound area was 8.44 cm2
. Median time to wound healing was 10 weeks. 57.1% of patients achieved complete wound closure at3 months. There was significant WAR after 1 month (mean area 8.44–5.81 cm2 , 31.2% decrease) and after 3 months (mean area 8.44–2.53 cm2 , 70.0% decrease). Mean monthly WAR was 28.9%. PUSH score also decreased at 1 month (16.5% decrease, p < 0.001) and 3 months (63.3% decrease, p < .001) marks following the sequential therapy. EuroQol Visual Analog Scale (EQ‐VAS) improved following sequential therapy
(baseline: 69.0 ± 15.0, week 13: 80.2 ± 13.2, p < 0.001).
Conclusion: Sequential therapy with TLC‐Ag followed by TLC‐NOSF and 2LB is feasible, with good wound healing and improvement in QOL of patients with VLUs.

Application Tips – [Application Tips] UrgoStart Contact Layer

Welcome to this step by step guide on how to use UrgoStart Contact layer dressings.

All UrgoStart dressings are the only dressings clinically proven to reduce the healing time of wounds, thanks to the unique TLC-NOSF healing matrix.

All UrgoStart dressings are indicated for leg ulcers, diabetic foot ulcers, pressure ulcers and wounds that are at the risk of delayed healing.

UrgoStart contact layer dressings are pain-free at removal so you won’t cause unnecessary pain to your patients during dressing changes.

How to apply UrgoStart contact layer dressings:
• Cleanse the wound as per local protocol. Dry the surrounding skin carefully.
• Apply UrgoStart contact layer directly to the wound
• UrgoStart contact layer can be combined with a secondary dressing, suitable for the location and level of exudate, and secure it in place
• Apply the compression bandage system when prescribed (for mixed or venous leg ulcers)
• UrgoStart contact layer may be left in place up to 7 days, however change the dressing as advised by your healthcare professional.