Wound infections, including biofilms play a significant role in delaying
wound healing and are considered to be one of the major challenges in
wound management. The presence of non-viable tissue, such as slough, is a
prominent feature of chronic wounds and is considered as a barrier against
successful wound healing. A key component in wound care is to integrate
in our care evidence-based dressings that provides continuous cleaning,
antimicrobial activity and which are also effective against biofilms.
UrgoClean Ag is a dressing composed of cohesive poly-absorbent fibres
impregnated with a silver lipido-colloid matrix (Technology Lipido-Coloid Ag healing matrix [TLC-Ag]) that has shown very good results in clinical trials,
including a prospective, multicentre, non-comparative clinical trial, but also
large scale observational studies. In this article, we attempt to replicate the
results obtained in Europe in patients from different countries in the Asian
Continent by means of a case series.
Archives
The Importance of Pain Reduction through Dressing Selection in Routine Wound Management The MAPP Study
Objective: To discover the incidence of pain in patients with acute or chronic wounds of various
causes during dressing removal, and the effect of switching to a non-adherent dressing.
l Method: A total of 656 primary care physicians reported the relevant details of all acute or chronic
wounds observed during routine visits throughout the study period. The pain experienced during
dressing changes was systematically evaluated. In patients with moderate to severe pain, a more
extensive evaluation was performed and they were invited to complete a self-evaluation questionnaire.
If the patients were seen at a subsequent visit, a new evaluation was performed.
l Results: In total 5850 patients were seen: 2914 with acute wounds and 2936 with chronic wounds.
During dressing changes, a similar number of patients with acute and chronic wounds reported
‘moderate to severe’ pain during the medical screening visit (79.9% and 79.7%) and ‘very severe’ pain in
their self-evaluation questionnaire completed at home (47% and 59% respectively). Dressing removal
was most painful when there was adherence to the wound bed. Switching to a new, non-adherent
dressing reduced pain during dressing changes in 88% of patients with chronic wounds and 95% of
patients with acute wounds.
l Conclusion: This study demonstrates that similar problems with patient acceptability arise
irrespective of wound aetiology. Pain is a major problem and is most often related to dressing selection.
Selecting a suitable, non-adherent dressing improves patient acceptability.
Management of Burn Wounds by a Technology Lipido-Colloid Polyacrylate Dressing Impregnated with Silver A Case Series from Vietnam
Burn injuries are a mostly avoidable trauma that affect millions of people
worldwide every year. Wound healing in burn patients is complex, and
infection is one of the main clinical complications associated with wound
care in burn patients. Biofilms are mostly associated with chronic wounds,
but have also been identified in acute, traumatic wounds. This article
shows an evaluation of a TLC-polyacrylate fibre dressing impregnated with
silver to manage burn wounds of different severities, in nine patients of
different ages from Vietnam. The outcomes show encouraging results in
the management of burns when considering healing properties, and also
management of infection, desloughing and wound healing outcomes.
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.
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.
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.
UK NICE 2023 MTG42 UrgoStart for treating diabetic foot ulcers and leg ulcers
Evidence-based recommendations on UrgoStart for treating diabetic foot ulcers and leg ulcers.
In April 2023, NICE updated section 1 to reflect the current format of NICE guidance. NICE also added some text to the clinical evidence section to summarise new clinical evidence reviewed. NICE’s recommendations for UrgoStart remain unchanged. More details are in the review decision. New text is marked [2023].
NICE medical technologies guidance addresses specific technologies notified to NICE by sponsors. The ‘case for adoption’ is based on the claimed advantages of introducing the specific technology compared with current management of the condition. This case is reviewed against the evidence submitted and expert advice. If the case for adopting the technology is supported, then the technology has been found to offer advantages to patients and the NHS. The specific recommendations on individual technologies are not intended to limit use of other relevant technologies which may offer similar advantages.
This guidance replaces NICE medtech innovation briefing on UrgoStart for chronic wounds (MIB82).
Clinical Evaluation of a Dressing with Poly-Absorbent Fibres and a Silver Matrix for Managing Chronic Wounds at Risk of Infection A Non-Comparative Trial
Objective: To assess the efficacy, safety and acceptability of a new
silver poly absorbent dressing (UrgoCleanAg) in the local management
of exudative chronic wounds at risk of infection, with inflammatory
signs suggesting heavy bacterial load.
Method: This prospective, multicentre, non-comparative clinical trial
was conducted in French hospital wards (dermatology and vascular
medicine) or specialised private-practice physicians. Patients were
considered at high-risk of infection when presenting with at least three
of five selected inflammatory clinical signs, suggesting a heavy
bacterial load (pain between two dressing changes, erythema, oedema,
malodorous wound and presence of a heavy exudate). They were
treated for a maximum period of four weeks, and followed by the
physician on a weekly basis, including a clinical examination, area
tracings and photographs. The primary efficacy criterion of the trial was
the relative wound surface area reduction at the end of the four weeks
of treatment. Acceptability was documented by the nursing staff at
each dressing change between the weekly evaluations.
Results: We recruited 37 patients with chronic wounds. Wound
surface area, mostly covered by sloughy tissue, was reduced by 32.5%
at the end of the treatment (median value), while the clinical score
(maximum value of 5, based on inflammatory clinical signs) decreased
from 4.0 to 2.0. Effective debridement properties were documented
(62.5% relative reduction of sloughy tissue at week 4; 58.8% of
debrided wounds at week 4) and improvement of the periwound skin
status was noted (healthy for 28.6% of the patients at week 4 versus
2.7% at baseline). In addition, the tested wound dressing presented a
good safety profile associated to a high level of acceptability, noted by
both patients and nursing staff.
Conclusion: These clinical data support that the tested dressing is a
credible therapeutic alternative for the management of chronic
wounds at risk of infection with inflammatory signs suggesting heavy
bacterial load.
Declaration of interest: This study was sponsored by a grant from
the pharmaceutical company Laboratoires Urgo. S. Bohbot and Z.
Lemdjadi are employees of Laboratoires Urgo. L. Sigal has received
monetary compensation as a speaker for Laboratoires Urgo. Data
management and statistical analyses were conducted independently
by Altizem.