Clinical evaluation of polyabsorbent TLC-NOSF dressings on chronic wounds: a prospective, observational, multicentre study of 1140 patients

2020 ◽  
Vol 29 (6) ◽  
pp. 350-361 ◽  
Author(s):  
Joachim Dissemond ◽  
Steffen Lützkendorf ◽  
Michael Dietlein ◽  
Ingo Neßeler ◽  
Elisa Becker ◽  
...  
Keyword(s):  
Wound Healing ◽  
Chronic Wounds ◽  
Local Treatment ◽  
Real Life ◽  
Standard Of Care ◽  
Final Visit ◽  
Quality Level ◽  
Local Tolerability ◽  
Unselected Population ◽  
Randomised Controlled

Objective: The superior wound healing properties and cost-effectiveness of TLC-NOSF dressings in the local treatment of chronic wounds have already been demonstrated by several randomised controlled trials (RCTs) at a high quality level. Therefore, this study aimed to evaluate the efficacy and safety of new TLC-NOSF dressings with polyabsorbent fibres in an unselected population of patients under real-life conditions. Method: A large, prospective, multicentre, observational study with two polyabsorbent TLC-NOSF dressings (UrgoStart Plus Pad and UrgoStart Plus Border, Laboratoires Urgo, France) was conducted in Germany between July 2017 and December 2018. Main outcomes included wound healing rate, clinical assessment of wound healing progression, local tolerability and acceptance of dressings. Results: A total of 1140 patients with chronic wounds of various aetiologies (leg ulcers, diabetic foot ulcers, pressure ulcers, etc.) were treated with the investigated dressings in 130 centres, for a mean duration of 56±34 days. By the final visit, 48.5% of wounds had healed and 44.8% had improved. Similar results were reported regardless of wound aetiology or regardless of proportions of sloughy and granulation tissue at the start of treatment. According to the subgroup analysis by wound duration, the sooner the TLC-NOSF treatment was initiated, the better the clinical outcomes for all types of wounds. The dressings were very well tolerated and accepted by the patients. Conclusion: These results are consistent with those from RCTs conducted on TLC-NOSF dressings. They complete the evidence on the good healing properties and safety profile of these dressings, especially in non-selected patients treated in current practice, and regardless of the characteristics of wounds and patients. They support the use of the dressings as a first-line intervention and until wound healing in the management of chronic wounds, in association with appropriate standard of care.

Clinical evaluation of UrgoStart Plus dressings in real-life conditions: results of a prospective multicentre study on 961 patients

2021 ◽  
Vol 30 (12) ◽  
pp. 966-978
Author(s):  
Matthias Augustin ◽  
Winfried Keuthage ◽  
Ralf Lobmann ◽  
Steffen Lützkendorf ◽  
Hauke Groth ◽  
...  
Keyword(s):  
Wound Healing ◽  
Wound Closure ◽  
Chronic Wounds ◽  
Healing Process ◽  
Real Life ◽  
Final Visit ◽  
Relative Reduction ◽  
First Line ◽  
Local Tolerance ◽  
Life Conditions

Aims: This study aimed to evaluate the performances of lipid colloid technology with nano-oligosaccharide factor (TLC-NOSF) dressings with polyabsorbent fibres in an unselected population of patients under real-life conditions. Methods: A large, prospective, multicentre, observational study with three polyabsorbent TLC-NOSF dressings (UrgoStart Plus Pad, UrgoStart Plus and UrgoStart Plus Border, Laboratoires Urgo, France) was conducted in Germany between January 2019 and June 2020. Main outcomes included wound healing rate, clinical assessment of wound healing progression, local tolerance and acceptance of dressings, and changes in health-related quality of life (HRQoL) of the patients, assessed with the validated Wound-QoL questionnaire. Results: A total of 961 patients with wounds of various aetiologies (leg ulcers (LU), diabetic foot ulcers (DFU), pressure ulcers (PU) and other types of wounds) were treated with the evaluated dressings in 105 centres for a mean duration of 62 days (standard deviation 37 days). By the last visit, a wound closure or an improvement in wound healing was reported in 92.0% of the treated wounds. The highest wound closure rates were achieved when the dressings were used as first-line treatment: 71.3% in DFUs, 52.9% in LUs, 53.6% in PUs and 61.8% in the other wounds. Improvement of the wound healing process was also associated with an 87.5% relative reduction of sloughy tissue, a decrease of the level of exudate in 68.9% of the wounds, and an improvement in the periwound skin condition in 66.4% of the patients at the final visit. The dressings were ‘very well’ or ‘well’ tolerated and ‘very well’ or ‘well’ accepted by the large majority of patients. The HRQoL questionnaires were completed both at initial and final visits by 337 patients, representative of the total cohort. Despite the relatively short duration of the wounds, the HRQoL of the patients was already impaired at baseline, with 81.6% of the patients being severely affected in at least one aspect of their HRQoL. By the final visit, significant improvements in each dimension of the patients' HRQoL were reported (p<0.001), along with a reduction of the proportion of patients in need of intervention and in the number of actions needed per patient in relation to their HRQoL. Conclusions: These results are consistent with previous clinical evidence on TLC-NOSF dressings. They confirm the good healing properties and safety profile of these dressings, and that a significant improvement in patient HRQoL is achieved in non-selected patients treated in real-life practice. These data support the use of such dressings as a first-line intervention and until wound healing in the management of chronic wounds, in association with appropriate standard of care.

scholarly journals Stimulation of Healing of Non-Infected Stagnated Diabetic Wounds by Copper Oxide-Impregnated Wound Dressings

Medicina ◽  
2021 ◽  
Vol 57 (10) ◽  
pp. 1129
Author(s):  
Eyal Melamed ◽  
Alexei Rovitsky ◽  
Tohar Roth ◽  
Lior Assa ◽  
Gadi Borkow
Keyword(s):  
Wound Healing ◽  
Copper Oxide ◽  
Chronic Wounds ◽  
Wide Spectrum ◽  
Weight Bearing ◽  
Standard Of Care ◽  
Wound Dressings ◽  
Diabetic Patients ◽  
Intelligence System ◽  
Diabetic Wounds

Background and Objective: Copper, a wide spectrum biocide, also plays a key role in angiogenesis and wound healing. Antibacterial wound dressings impregnated with copper oxide microparticles (COD) have been recently cleared by the U.S. FDA and other regulatory bodies for the treatment of acute and chronic wounds, including diabetic wounds. Our objective was to evaluate the capacity of COD in stimulating the healing of non-infected stagnated wounds in diabetic patients initially treated with standard of care (SOC) dressings. Materials and Methods: The trial was divided into the three following phases: 1–2 weeks of screening, during which the patients were treated with SOC dressings; 4 weeks of treatment, during which the COD was applied twice weekly; and 2 weeks of follow-up, during which the patients were again treated with SOC dressings. The wound conditions and sizes were assessed by clinical evaluation and a wound imaging artificial intelligence system. Results: Following 1 month of COD treatment, there was a clear reduction in the mean wound area (53.2%; p = 0.003), an increase in granulation tissue (43.37; p < 0.001), and a reduction in fibrins (47.8%; p = 0.002). In patients with non-weight-bearing wounds, the reduction in wound size was even more dramatic (66.9%; p < 0.001). Conclusions: The results of this study, showing a statistically significant influence of COD on wound healing of hard-to-heal wounds in diabetic patients, strongly supports the notion that copper oxide-impregnated dressings enhance wound healing directly. Further larger controlled studies should be conducted to substantiate our findings.

scholarly journals Vivostat Platelet-Rich Fibrin® for Complicated or Chronic Wounds—A Pilot Study

Biomedicines ◽  
2020 ◽  
Vol 8 (8) ◽  
pp. 276
Author(s):  
Andreas Bayer ◽  
Gesa Höntsch ◽  
Mark Kaschwich ◽  
Annika Dell ◽  
Markus Siggelkow ◽  
...  
Keyword(s):  
Wound Healing ◽  
Pilot Study ◽  
Clinical Efficacy ◽  
Chronic Wounds ◽  
Local Treatment ◽  
Entire Study ◽  
Platelet Rich Fibrin ◽  
Arterial Blood ◽  
Autologous Platelet Concentrate ◽  
Study Population

Vivostat Platelet-Rich Fibrin® (PRF) is an autologous platelet concentrate used for the local treatment of chronic or complicated wounds. Still, its application for this indication is not evidence-based. Therefore, we performed this monocentric retrospective pilot study investigating the clinical outcome of a local treatment of chronic or complicated wounds in 35 patients (23 male, 12 female, mean age 68.7 years) treated with Vivostat PRF®. This study population is the largest among published studies analyzing the clinical efficacy of Vivostat PRF® on chronic wounds so far. Using the perpendicular method we divided the wounds into three sizes (<10, 10–30, and >30 cm2). The clinical efficacy of the Vivostat PRF treatment was the primary endpoint and was divided into three groups of increasing degrees of wound improvement: (1) no improvement of the wound (wound area was not reduced > 10% under Vivostat PRF® treatment), (2) improvement of the wound (reduced area > 10% under Vivostat PRF® treatment) and (3) complete epithelialization (wounds that were completely re-epithelialized after Vivostat PRF® treatment). We included patients’ diagnosis and concomitant diseases (peripheral arterial occlusive disease (PAOD)), chronic venous insufficiency (CVI)), diabetic foot syndrome (DFS)) in our data analysis in order to investigate their potential impact on the wound healing capacity of Vivostat PRF®. Our results show that in the entire study population, 13 out of 35 (37.1%) patients experienced wound improvement and 14 out of 35 (40%) patients showed complete epithelialization of their wound under Vivostat PRF® treatment. In summary, 77.1% of the treated patients benefited from the Vivostat PRF® therapy. These positive wound healing effects were all observed within the first three to six Vivostat PRF® applications. Subgroup analyses showed that Vivostat PRF® appeared to be more efficient in patients without CVI in comparison to patients with CVI (p = 0.02). Moreover, Vivostat PRF® treatment seems to be particularly efficient in PAOD-related wounds with a reduced crural arterial blood supply (p = 0.01). Additionally, we performed an experimental human in vivo study on ten male students where we artificially generated bilateral gluteal wounds and analyzed the influence of the Vivostat PRF® treatment on the expression of two genes (human beta Defensin-2, ((hBD-2) and human beta-Defensin-3 (hBD-3)) in keratinocytes of resected wound specimens that are induced during wound healing. Interestingly, this analysis revealed that only seven of out ten individuals showed a relevant hBD-2 and hBD-3 gene induction after Vivostat PRF® treatment. This led to the novel “key-lock-hypothesis”. With the goal of an individualized precision medicine approach with optimized wound treatment strategies in the future, this is an important observation that demands further experimental and clinical studies.

scholarly journals A randomised controlled pilot trial of oral 11β-HSD1 inhibitor AZD4017 for wound healing in adults with type 2 diabetes mellitus

2021 ◽  
Author(s):  
Ramzi Ajjan ◽  
Elizabeth MA Hensor ◽  
Kave Shams ◽  
Francesco Del Galdo ◽  
Afroze Abbas ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Wound Healing ◽  
Wound Repair ◽  
Chronic Wounds ◽  
Pilot Trial ◽  
Punch Biopsy ◽  
Preclinical Research ◽  
Double Blind ◽  
Randomised Controlled

Chronic wounds (e.g. diabetic foot ulcers) have a major impact on quality of life, yet treatments remain limited. Glucocorticoids impair wound healing; preclinical research suggests that blocking glucocorticoid activation by the enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) improves wound repair. This investigator-initiated double-blind, randomised, placebo-controlled parallel-group phase 2b pilot trial investigated efficacy, safety and feasibility of 11β-HSD1 inhibition for 35 days by oral AZD4017 (AZD) treatment in adults with type 2 diabetes (n=14) compared to placebo (PCB, n=14) in a single-centre secondary care setting. Computer-generated 1:1 randomisation was pharmacy-administered. From 300 screening invitations, 36 attended, 28 were randomised. There was no proof-of-concept that AZD inhibited 24 hour skin 11β-HSD1 activity at day 28 (primary outcome: adjusted difference AZD-PCB 90% CI (diffCI)=-3.4,5.5) but systemic 11β-HSD1 activity (median urinary [THF+alloTHF]/THE ratio) was 87% lower with AZD at day 35 (PCB 1.00, AZD 0.13, diffCI=-1.04,-0.69). Mean wound gap diameter (mm) following baseline 2mm punch biopsy was 34% smaller at day 2 (PCB 1.51, AZD 0.98, diffCI=-0.95,-0.10) and 48% smaller after repeat wounding at day 30 (PCB 1.35, AZD 0.70, diffCI=-1.15,-0.16); results also suggested greater epidermal integrity but modestly impaired barrier function with AZD. AZD was well-tolerated with minimal side effects and comparable adverse events between treatments. Staff availability restricted recruitment (2.9/month); retention (27/28) and data completeness (95.3%) were excellent. These preliminary findings suggest that AZD may improve wound healing in patients with type 2 diabetes and warrant a fully-powered trial in patients with active ulcers. [Trial Registry: www.isrctn.com/ISRCTN74621291. Funding: MRC Confidence in Concept and NIHR Senior Investigator Award.]

Use of a TLC-Ag dressing on 2270 patients with wounds at risk or with signs of local infection: an observational study

2020 ◽  
Vol 29 (3) ◽  
pp. 162-173 ◽  
Author(s):  
Joachim Dissemond ◽  
Michael Dietlein ◽  
Ingo Neßeler ◽  
Lutz Funke ◽  
Oliver Scheuermann ◽  
...  
Keyword(s):  
At Risk ◽  
Wound Healing ◽  
Observational Study ◽  
Chronic Wounds ◽  
Healing Process ◽  
Clinical Signs ◽  
Real Life ◽  
Wound Healing Process ◽  
Wound Infections ◽  
Local Infection

Objective: A description of wounds treated with a poly-absorbent silver dressing (with technology lipido-colloid with silver ions, TLC-Ag), and evaluation of the short-term clinical impact of the dressing on the wound healing process, under real-life conditions. Method: A large, prospective, multicentre, observational study of patients in 81 centres in Germany, presenting with an exuding wound at risk or with clinical signs of local infection for whom the evaluated TLC-Ag dressing (UrgoClean Ag, Laboratoires Urgo, France) has been prescribed. Main outcomes included: reduction in number of wound infections diagnosed and clinical signs of local infection, wound healing rate, clinical assessment of wound healing progression, relative wound area reduction (RWAR), local tolerability, handling and acceptance of the dressing. Results: A total of 2270 patients with acute and chronic wounds of various aetiologies were treated with the evaluated dressing for a mean duration of 22±13 days. All clinical signs of local infection and the diagnosed wound infections were substantially reduced at two weeks after the treatment initiation. All wound infection parameters continued to reduce until the last visit. In the meantime, clinical improvement in wound healing was reported in 98.9% of acute wounds, with a wound closure rate of 68.5%. In chronic wounds, a median RWAR of 57.4% was achieved, with an improvement in healing process documented by clinicians in 90.6% of cases, stabilisation in 6.1% and worsening in 3.2%. Similar results were reported, regardless of exudate level and proportion of sloughy and granulation tissues in the wound bed at baseline. The dressing was well tolerated and well accepted by both patients and health professionals. Conclusion: These results, documented in a large cohort of patients treated in current practice, support and complete the clinical evidence on the healing properties and safety profile of the TLC-Ag dressing in the management of wounds at risk or with clinical signs of local infection, regardless of wound and patient characteristics. Declaration of interest: This study was supported by a grant from Laboratoires Urgo. UM, EB, LT and SB are employees of Laboratoires Urgo. JD, KCM and MD provided advisory and speaking services to pharmaceutical and other healthcare organisations including, but not limited to, Laboratoires Urgo. Data management and statistical analyses were conducted independently by INPADS GmbH, Germany.

scholarly journals Wound dressings: curbing inflammation in chronic wound healing

2021 ◽  
Author(s):  
Davide Vincenzo Verdolino ◽  
Helen A. Thomason ◽  
Andrea Fotticchia ◽  
Sarah Cartmell
Keyword(s):  
Wound Healing ◽  
Chronic Wounds ◽  
Chronic Wound ◽  
Wound Care ◽  
Healing Process ◽  
Standard Of Care ◽  
The Elderly ◽  
Wound Dressings ◽  
Wound Healing Process

Chronic wounds represent an economic burden to healthcare systems worldwide and a societal burden to patients, deeply impacting their quality of life. The incidence of recalcitrant wounds has been steadily increasing since the population more susceptible, the elderly and diabetic, are rapidly growing. Chronic wounds are characterised by a delayed wound healing process that takes longer to heal under standard of care than acute (i.e. healthy) wounds. Two of the most common problems associated with chronic wounds are inflammation and infection, with the latter usually exacerbating the former. With this in mind, researchers and wound care companies have developed and marketed a wide variety of wound dressings presenting different compositions but all aimed at promoting healing. This makes it harder for physicians to choose the correct therapy, especially given a lack of public quantitative data to support the manufacturers’ claims. This review aims at giving a brief introduction to the clinical need for chronic wound dressings, focusing on inflammation and evaluating how bio-derived and synthetic dressings may control excess inflammation and promote healing.

The effects and use of negative pressure wound therapy – a set of case reports

2020 ◽  
Vol 99 (4) ◽  
pp. 183-188
Keyword(s):  
Wound Healing ◽  
High Risk ◽  
Negative Pressure ◽  
Negative Pressure Wound Therapy ◽  
Chronic Wounds ◽  
Wide Spectrum ◽  
Case Reports ◽  
Modern Medicine ◽  
Wound Therapy ◽  
Basic Set

Modern medicine offers a wide spectrum of wound healing resources for acute or chronic wounds. Negative pressure wound therapy (NPWT) is a very effective method, allowing complicated defects and wounds to heal. The basic set is usually provided with various special accessories to facilitate the use and support safe application of NPWT to high-risk tissue. Selected case reports are presented herein to document the special use and combinations of materials in negative pressure wound therapy.

The Impact of Angiotensin-II Receptor Blockers on Cardiovascular Events in Hypertensive Patients – Evidence from Real-life Databases

2010 ◽  
Vol 6 (3) ◽  
pp. 33
Author(s):  
Robert J Petrella ◽  
Keyword(s):  
Angiotensin Ii ◽  
Antihypertensive Drugs ◽  
Real Life ◽  
Angiotensin Ii Receptor Blockers ◽  
Angiotensin Ii Receptor ◽  
Real World Setting ◽  
Actual Experience ◽  
Receptor Blockers ◽  
Randomised Controlled ◽  
The Impact

It is widely recognised that hypertension is a major risk factor for the development of future cardiovascular (CV) events, which in turn are a major cause of morbidity and mortality. Blood pressure (BP) control with antihypertensive drugs has been shown to reduce the risk of CV events. Angiotensin-II receptor blockers (ARBs) are one such class of antihypertensive drugs and randomised controlled trials (RCTs) have shown ARB-based therapies to have effective BP-lowering properties. However, data obtained under these tightly controlled settings do not necessarily reflect actual experience in clinical practice. Real-life databases may offer alternative information that reflects an uncontrolled real-world setting and complements and expands on the findings of clinical trials. Recent analyses of practice-based real-life databases have shown ARB-based therapies to be associated with better persistence and adherence rates and with superior BP control than non-ARB-based therapies. Analyses of real-life databases also suggest that ARB-based therapies may be associated with a lower risk of CV events than other antihypertensive-drug-based therapies.

Qualitative assessment of equipment failure cause finding and removal

2018 ◽  
pp. 116-126
Author(s):  
E. A. Vakulin ◽  
A. I. Zayats ◽  
V. A. Beklemeshev ◽  
V. A. Ivashkevich ◽  
V. A. Khazhiev ◽  
...  
Keyword(s):  
Production Condition ◽  
Real Life ◽  
Open Pit Mine ◽  
Qualitative Assessment ◽  
Open Pit ◽  
Quality Level ◽  
Equipment Failure ◽  
Operation Conditions ◽  
Failure Investigation

Investigation of failures is one of the critical activities of mining and haulage equipment operability assurance in mining. Maintaining failure investigation at the required quality level, it is possible to identify provisions, rules and procedures that should be revised or changed, operation conditions that should be improved, additional personnel training, if required, etc. Investigation of failures in mines is under responsibility of machine men and electricians of maintenance and operation services. In reality, factory management and setup for production condition weak concernment of these workers in quality investigation aimed at finding of sources of equipment failures. This article describes real-life results achieved in development and use of maintenance service operation, technology and management monitoring. The requirements are substantiated for quality improvement in failure cause finding and removal in mining and haulage equipment at Chernogorsky open pit mine, SUEK-Khakassia. Causes of the present quality of failure investigation by machine men of Chernogorsky Repair and Engineering Works and Chernogorsky open pit mine are revealed. The proposed recommended practices will improve quality of mining and haulage equipment failure investigation.

Experience of using atraumatic ointment bandages based on peruvian balsam in the complex treatment of patients with chronic wound defects of the lower limbs

2020 ◽  
pp. 43-57
Author(s):  
Anna Tabuika
Keyword(s):  
Diabetes Mellitus ◽  
Staphylococcus Aureus ◽  
Chronic Wounds ◽  
Chronic Wound ◽  
Local Treatment ◽  
Lower Limbs ◽  
Complex Treatment ◽  
Average Area ◽  
Arterial Insufficiency ◽  
Significant Activation

The article reflects the results of a retrospective non-comparative study, the objects of which were 34 outpatient comorbid patients (15 of which are over 60 years old) with chronic wounds of the lower limbs developed against the background of varicosity, post-thrombotic disease, chronic arterial insufficiency of the lower limbs, diabetes mellitus or their combination. Their local treatment was carried out using atraumatic ointment dressing «Branolind N» containing Peruvian balsam. There were 23 women (67.6 %) and 11 men (32.4 %). In microbiological study prior to the beginning of treatment in 31 patients the growth of a pathogen of wound infection was revealed; in 19 patients — Staphylococcus aureus in monoculture and in various associations, in 6 patients — Pseudomonas aeruginosa in monoculture, in other cases — other pathogens. In 3 patients the pathogen was not detected. The average wound size was 34 cm2 . The phase of the wound process was additionally confirmed by cytological studies. After treatment the average area of the wound defect decreased by 10 cm2 and made 24 cm2 on average. Full healing of the wound defect occurred in 11 patients, the others had granulation and active marginal epithelization. There was also a decrease in bacterial semination of wounds, a change in composition of infection agents to less aggressive monoflora, and cytologically — a decrease in signs of inflammation against the background of significant activation of reparative processes.

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