OBJECTIVE: To evaluate the healing of venous ulcers in the lower limbs (VLU) using dressings with hydrocolloid gel associated with Syzygium cumini extract (SHG) compared to standard hydrocolloid gel dressings (HG).
METHODS: This prospective, double-blind, randomized trial recruited 90 patients with VLU divided into: dressings with SHG (n = 44) and dressings with HG (n = 46). Primary endpoint was healing in the 14th visit. Secondary endpoints were healing rate, complete healing during follow-up, and improvement in the pain scale and in quality of life.
RESULTS: There were no significant between-group differences in healing (p = 0.15). The wound area made healing difficult (p = 0.008). Age, body mass index, and wound time demonstrated a tendency to worsen the healing. Positive culture for Pseudomonas aeruginosa resulted in 88% reduction in the healing risk (p < 0.0001).
CONCLUSIONS: There was no difference between the dressings evaluated. The presence of Pseudomonas aeruginosa significantly impaired wound healing.

Venous leg ulcers are frequently colonized by microbes. This can be particularly devastating if the ulcer is infected with alert pathogens, i.e., highly virulent microorganisms with well-developed mechanisms of antibiotic resistance. We analyzed the microbiological status of venous leg ulcers and identified the clinicodemographic predictors of culture-positive ulcers, especially in ulcers with colonization by alert pathogens.
This study included 754 patients with chronic venous leg ulcers. Material for microbiological analysis was collected by swabbing only from patients who did not receive any antibiotic treatment.
A total of 636 (84.3%) patients presented with culture-positive ulcers. Alert pathogens, primarily Pseudomonas aeruginosa, were detected in 28.6% of the positive cultures. In a logistic regression model, culture-positive ulcers were predicted independently by age > 65 years, current ulcer duration > 12 months, and ulceration area greater than 8.25 cm2. Two of these factors, duration of current ulcer > 12 months and ulceration area > 8.25 cm2, were also identified as the independent predictors of colonization by alert pathogens.
Colonization/infection is particularly likely in older persons with chronic and/or large ulcers. Concomitant atherosclerosis was an independent predictor of culture-negative ulcers.

UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.

UNASSIGNED: The efficacy of available wound dressings in the treatment of hard-to-heal wounds is limited. A new therapeutic approach using an acid-oxidising solution (AOS) was developed. Its effect on healing progress, tolerability and safety properties were investigated in a clinical study, and compared with standard of care (SOC) wound dressings. The study aimed to demonstrate the non-inferiority of AOS to SOC in terms of wound healing progress.
UNASSIGNED: This open-label, randomised controlled trial was conducted at two study centres in Austria with patients with either infected or non-infected hard-to-heal leg ulcers of different aetiology. Patients were treated for six weeks either with AOS or SOC wound dressings. Outcome assessments included the percentage of granulation and re-epithelialisation tissue, wound size reduction, changes in wound pH, infection control and wound pain, local tolerability and adverse events (AEs). Healing time and rate were also assessed.
UNASSIGNED: A total of 50 patients took part. In the AOS group, wounds exhibited higher amounts of granulation and re-epithelialisation tissue, and a faster and more pronounced wound size reduction compared with wounds in the SOC group. In the AOS-treated versus SOC-treated patients, a greater percentage of complete healing of hard-to-heal ulcers was achieved by the end of the study period (32% versus 8%, respectively). Furthermore, the wound pH decreased significantly faster in these wounds (p<0.0001). In all patients with infected leg ulcers, local infection was overcome more rapidly under AOS treatment. In the AOS group, one AE and no serious adverse events (SAEs) were detected versus 24 AEs and two SAEs in the SOC group.
UNASSIGNED: In this study, AOS proved to be a highly effective treatment to support wound healing in infected or non-infected hard-to-heal leg ulcers of different aetiology. Efficacy was found to be not only non-inferior but superior to SOC wound dressings. Furthermore, tolerability and safety profiles were favourable for AOS.

UNASSIGNED: Compression therapy is the cornerstone of therapeutic management of patients with chronic venous insufficiency (CVI). This study aimed to evaluate the efficacy and safety of a multicomponent compression system in an unselected population of patients with CVI problems under real-life conditions.
UNASSIGNED: A prospective, multicentre, observational study with a multicomponent two-bandage compression system (UrgoK2, Laboratoires Urgo, France) was conducted in 103 centres in Germany. Main outcomes included wound healing rate, wound healing progression, assessment of oedema and ankle mobility, local tolerability and acceptance of the compression therapy.
UNASSIGNED: A total of 702 patients with venous leg ulcers (VLU) and/or with lower limb oedema due to CVI were treated with the evaluated system for a mean (±standard deviation) duration of 27±17 days. By the last visit, 30.9% of wounds had healed and 61.8% had improved. Limb oedema was resolved in 66.7% of patients and an improvement of ankle mobility was reported in 44.2% of patients. The skin condition under the compression therapy was also considered as improved in 73.9% of patients and a substantial reduction of pain was achieved, both in number of patients reporting pain and in pain intensity. Compression therapy with the evaluated system was \'very well\' or \'well\' tolerated and \'very well\' or \'well\' accepted by >95% of patients. These positive outcomes were in line with the general opinion of physicians on the evaluated compression bandages, which were judged \'very useful\' or \'useful\' for >96.6% of patients. Similar results were reported regardless of the treated condition, VLU and/or limb oedema.
UNASSIGNED: Real-life data documented in this large observational study of non-selected patients receiving compression therapy in daily practice confirm the benefits and safety profile of the evaluated compression system. This study also confirms the high-level of performance and acceptability of the system, regardless of the characteristics of the wounds or patients at initiation of the treatment. The data support the use of this multicomponent compression system as one first-line intervention in patients with symptoms caused by CVI.

Introduction Saudi Arabia has a high prevalence of sickle cell disease (SCD). Leg ulceration is one of the complications associated with SCD. There is a gap in the literature in regard to the prevalence of leg ulcers among SCD patients in Saudi Arabia. Objectives The primary objective of this study was to evaluate the lifetime prevalence of leg ulcers in SCD patients in our population and to study the predictive factors of leg ulcers by using sociodemographic factors, clinical manifestations of SCD, and other relevant factors like hydroxyurea. Methods A cross-sectional study design was utilized. Data collection was done using an electronic survey to collect self-reported information for the prevalence of leg ulcers and possible associated factors. The survey was distributed using social media platforms. Chi-square test was used to test for the presence of an association between having leg ulcers and sociodemographic variables as well as SCD related history. Furthermore, binary logistic regression was utilized to determine factors predicting the incidence of leg ulcers among SCD. Results A total of 790 valid responses were included in the study. Among these, 646 were included in the analysis of leg ulcers prevalence. From them, 52 (8%) SCD patients reported a history of leg ulcers. The male to female ratio was (9.7% vs 7.2%). The age group most affected by leg ulcers was those older than 50 (16.7%). There was no significant association between a history of leg ulcers and sociodemographic variables. The only predictive factors for leg ulcers were having six to eight vaso-occlusive crises per month and having more than eight vaso-occlusive crises per month. Conclusion Leg ulcers among SCD patients in Saudi Arabia were considerably prevalent (8%). There was no statistically significant correlation between leg ulceration and sociodemographic variables. Leg ulcers were more likely in patients with a history of highly frequent vaso-occlusive crises. No association was found between the incidence of leg ulcers and other complications of sickle cell disease or hydroxyurea.

BACKGROUND: The aim of the study was to analyze the dynamics of pain severity and its predictors in a group of patients with chronic venous leg ulcers.
METHODS: A 12-week longitudinal study included 754 patients with chronic venous leg ulcers. Subjective severity of pain was measured at weekly intervals with an 11-point visual analogue scale (VAS).
RESULTS: A significant decrease in VAS scores has been observed throughout the entire analyzed period. Higher severity of pain during follow-up was independently predicted by the presence of pus and/or unpleasant smell from the ulceration during the first visit, as well as by the occurrence of posterior and/or circumferential ulcers. The presence of ulcer redness during the first visit was associated with lesser pain severity; also, a significant interaction effect between the ulceration redness and warmth was observed.
CONCLUSIONS: Implementation of complex holistic care may contribute to a substantial decrease in the occurrence and severity of pain in a patient with venous leg ulcers. Pain control seems to depend primarily on clinical parameters and topography of venous ulcers. The predictors of pain severity identified in this study might be considered during the planning of tailored care for patients with venous leg ulcers.

OBJECTIVE: The aim of the study was to analyze bacterial flora in venous leg ulcers, empiric and targeted antibiotic therapy, and factors influencing healing time.
METHODS: Data from 30 patients with venous leg ulcers were retrospectively analyzed. Collected data included: sociodemographic data, wounds information, number of comorbidities, results of the microbiological examination, and empiric and targeted antibiotic therapy. To compare the empiric and targeted treatment in terms of their compatibility, the group of patients was divided into the four subgroups: NEA (no empiric antibiotics), NA (no antibiotics), ETA+ (compatibility of empiric and targeted antibiotic), ETA- (no compatibility of empiric and targeted antibiotic).
RESULTS: The average ulcer healing time was 163.4 ± 97.1 (range 51.0 to 426.0) days and increased by 28 days with each additional bacterial strain in the ulcer (p = 0.041). Healing time did not differ between the four groups. Staphylococcus aureus and Pseudomonas aeruginosa were the most frequent bacteria. Amoxicillinium/acidum clavulanicum was the most common empirical antibiotic and amoxicillinium/acidum clavulanicum, and levofloxacinum was the most common targeted antibiotic.
CONCLUSIONS: Venous leg ulcer healing time was prolonged with each subsequent bacterial strain in the ulcer, and it was independent from systemic antibiotic therapy.

OBJECTIVE: Determine standards of referral and management of patients with venous leg ulceration in primary care after the release of the EVRA (A Randomized Trial of Early Endovenous Ablation in Venous Ulceration) study results.
METHODS: An online questionnaire was disseminated over four months to professionals working within primary care.
RESULTS: The survey received 643 responses. Of respondents, 90 (14%) had heard of the EVRA trial and 51 (8%) were familiar with the results. Of those who answered the following questions, 410 (69.1%) stated that referral to a vascular specialist must be made by the General Practitioner and 13 (2.2%) reported that they would always refer patients for secondary care assessment before the publication of EVRA. Considering the EVRA results, 128 (29%) reported that they would change practice regarding referral and would experience no barriers and 198 (45%) reported that they would like to refer earlier but is not their decision. Barriers to changing practice included local referral policies, training and time restrictions, 266 (59%) had heard of the NICE guideline (CG168) and 194 (43%) were aware of the recommendations for referral to a vascular service within two weeks for patients with an open or healed ulcer.
CONCLUSIONS: There is a considerable variation in local referral pathways for venous leg ulceration, and despite clinicians wanting to refer promptly, many primary care professionals are unable to. Unfortunately, the EVRA study alone may not change the overall practice, and work is needed to overcome barriers faced by primary care professionals.

UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.