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.
Archives
UrgoClean AG in Real Life
In 2019, the International Diabetes Federation (IDF) reported
that over 77 million individuals have diabetes in India, which
will increase to over 100 million by 2030 (IDF, 2019). Of these
people with diabetes, 25% will develop a diabetic foot ulcer
(DFU), equating to 5 million by 2030. Overall, half of ulcers
become infected during the healing process, necessitating
hospitalisation, while 20% of these patients require amputation.
DFUs contribute to approximately 80% of all non-traumatic
amputations performed annually in India (Ghosh and Valia,
2017). It is indicated that social epidemiology regarding DFU in
India differs from the West due to many factors including socio economic and cultural factors. This can lead to significant delay
in specialist referral, with patients still relying on treatment based
on local ethnic methods and not based on scientific data. This
results in patients presenting with highly infected ulcers (Rastogi
and Bhansali, 2016).
Infections in wound management are closely associated with
delayed healing, increased complications such as amputation,
and, moreover, have a negative impact on patients’ quality of life
(Cutting, 2016; Armstrong et al, 2017). Furthermore, due to the
complications that ensue, infections can increase the economic
burden on healthcare facilities related to wound management
and increase hospital stay (Nussbaum et al, 2018). The overall
management plan for people with DFUs (and for that matter any
chronic wound) should include six spheres: mechanical control
or pressure offloading, medical/metabolic control of the diabetes
and comorbidities, microbiological/infection management,
vascular control ensuring adequate blood flow, wound control
and education aimed at increasing patient awareness of foot care
over their lifetime.
Management of wound infection needs to include understanding
and involvement of the patient’s response and the local wound
healing environment, as well as a reduction of the microbial load
as part of the standard of care. This will include wound cleansing,
debridement, and appropriate use of topical antimicrobials
(International Wound Infection Institute, 2016).
The use of technology lipido-colloid with silver (TLC-Ag) is
supported by high-quality clinical evidence in the management of
wounds at risk or presenting with clinical signs of local infection;
TLC-Ag dressings show superior efficacy in reducing wound
bioburden, while also promoting wound healing. Additionally,
results demonstrate high tolerance and acceptability of TLC-Ag
dressings because of their atraumatic properties (Lazareth et al,
2007; 2008; Schäfer et al, 2008; Lazareth et al, 2012; Allaert,
2014). TLC-Ag dressings with cohesive poly-absorbent fibres
(UrgoClean Ag) have been developed to manage wounds with
higher levels of exudate and trap sloughy residues and can be
used throughout the stages of wound healing (Meaume et al,
2012; 2014; Dissemond al, 2020).
This document showcases the outcomes of UrgoClean Ag
in a real-world environment, demonstrating enhancement in
the management of DFU in India with improvement in wound
conditions and, furthermore, enhancing the patients’ quality
of life and clinicians’ satisfaction. Clinicians and organisations
worldwide need to understand that appropriate wound
management interventions based on high-level evidence should
be used to formulate local guidelines and DFU care pathways
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.
Evaluation of Technology Lipido Colloid with Silver (TLC-Ag) Dressing Qinzhou (China) A Case Series
Safe management and prevention of wound infection has been
discussed and advocated by expert group consensus documents. Infection
is a significant problem in wound management and early identification
and intervention are considered as key to the patient’s wellbeing and
healing outcomes. Various agents have been applied topically to treat
infected wounds. A well-recognised option is the use of silver as a viable
antimicrobial, and in recent decades, safer modes of application have been
introduced. Here we discuss three cases from Qinzhou (China), where the
author evaluated a Technology Lipido-Colloid with silver (TLC-Ag) dressing.
Positive outcomes were reported in all cases, concordant with the clinical
outcomes documented in publications the results of other publications both
from Europe and Asia.
Management of Burn patients with Technology Lipido-Colloid with Silver Sulphate to Fight Local Infection and Restore the Healing Process
Burn wounds are predisposed to infection and topical antimicrobial
preparations are used both to prevent and treat infection. The choice
of topical antimicrobial should be based on the ability of the agent to
inhibit microorganisms that may be harmful within the wound bed and
on the host. Silver is indicated when a local negative impact of bacterial
colonisation is suspected and/or confirmed, because it has a broad
antimicrobial effect. Technology Lipido-Colloid (TLC) is a matrix containing
hydrocolloid and lipophilic substances that has been shown to promote
the proliferation of fibroblasts and to be atraumatic for patients. TLC-Ag
incorporates silver sulphate (3.5%) into the TLC matrix. When it is in contact
with the wound, the dressing releases a constant supply of antibacterial
silver. This article will discuss the use of antimicrobials in burn wound
management, show the evidence for the TLC-Ag antimicrobial healing
matrix and portray outcomes of cases of burns patients in India who have
been managed with TLC-Ag.
The Use of a Non-adherent Lipido-Colloid Dressings with Silver in the Management of Wounds
Silver has been used in wound care throughout the millennia for its
antimicrobial properties. It was used by many cultures, predominantly in
times of war, as an antimicrobial reservoir for food and water, from the
ancient Phoenicians, Greeks, Romans and Egyptians, up to the Second
World War (Alexander, 2009). The first mention of silver as a medicine
comes from Hippocrates, who used silver particles in wounds for its
beneficial therapeutic effects and anti-disease properties (Fong, 2005).
Meanwhile, John Woodall recommended the use of silver nitrate in
chronic wound management as early as 1617 (Klasen, 2000)
URGOTUL® AG/Silver Dressing as an Intermediate Layer in Negative Pressure Wound Therapy in a Patient with a Chronic Wound and History of Multiple Laparotomies
Treating of postoperative complications in patients after numerous laparotomies is
difficult. In the case of dehiscence the surgical wound, infection and the coexisting formation of
intestinal fistulas requires a multidisciplinary approach. In these cases, vacuum assisted thera py is very useful. However, it is necessary to protect the intestines, fistula and surrounding tissu es from the action of polyurethane foam – protect the intestines and skin against ingrowing into
the black foam. A 54-years-old male patient, with a history of numerous laparotomies was admit ted to Clinic to treat complications after left-sided nephrectomy. The patient developed intestinal
and enterocutaneous fistulas. Wound dehiscence and necrosis of surrounding tissues was pre sent. Negative pressure wound therapy was applied. Dressing was changed three times. Correc tion of the stomy was performed. UrgoTul® Ag/Silver was applied each time between the wound
and the polyurethane foam as a protective intermediate layer. The use of UrgoTul® Ag/Silver (in
patients with infection, dehiscence of wounds, and with enterocutaneous fistulas) showed a si gnificant decrease in the secretion from the intestinal fistula. Healing and closure of the surgical
wound, its epithelialization and elimination of inflammation of the abdominal wall was observed.
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.