Vascular Leg Research Articles

520-P: Bedside Amputation Surgery for Isolated Toe(s) Necrosis in a Diabetes Department—Prognostic after One-Year Follow-up

For isolated toe(s) necrosis complicating diabetic foot ulcers (DFU), level of amputation is a frequent topic of disagreement between diabetologists and surgeons. Bedside Amputation Surgery (BAS) performed by a diabetologist might be an option to get rid of a major surgery (complete transmetatarsal amputation [TMA] or transtibial amputation [TTA]) usually and initially recommended by the surgeon in this case. Indications of this practice need to be specified. This monocentric, retrospective, observational study assessed the outcome at 1 year of patients with diabetes mellitus (DM) after an accessible BAS performed by the diabetologist for isolated and delimited toe(s) necrosis consisting of transphalangeal amputation, metatarsophalangeal disarticulation or TMA of one axis. The primary endpoint is the one-year healing rate without secondary surgery performed by a surgeon in the operating room. Out of 783 patients admitted for DFU (05/2016-10/2021), 66 underwent BAS (8.5%). One-year follow-up was achieved for 55 patients (5 deaths from other causes and 6 lost of follow-up): males 82%, type 2 DM 96%, DM median duration 18 years, median HbA1C 9%. One-year healing rate was 62% (34/55). Among 21/55 patients with no healing at 1 year, 19 received secondary surgery in the operating room (TTA 32% (6/19), complete TMA 37% (7/19) and revision surgery gesture 31% (6/19), median delay: 41 days). Failure was observed in patients with more severe leg arteriopathy (1 vs 2 vascular leg axes, p=0.03) with no significant difference in foot vascularization. Soft tissue infection at the time of BAS was significantly more present in the unhealed group (80% vs 47%, p=0.02) with a higher CRP level (84 vs 23mg/L, p= 0.001). BAS allows optimal care in about 2 out of 3 cases, avoiding the need to perform major surgeries. The number of vascular leg axes (<1) as well as degree of soft tissue infection need to be assessed before suggesting the indication. Disclosure F.Féron: None. J.Riveline: Board Member; Abbott Diabetes, Medtronic, Dexcom, Inc., Novo Nordisk, Eli Lilly and Company, Sanofi. J.Gautier: Advisory Panel; Bayer Inc., Eli Lilly and Company, Sanofi, Other Relationship; Novo Nordisk. J.Kevorkian: None.

DIFFERENTIAL NUMBER OF LEUCOCYTES IN PATIENTS WITH TYPE 2 DIABETES MELLITUS TREATED WITH DIABETIC VASCULAR FOOT EXERCISE

Background : Disturbance Wound healing is one of the complications of type 2 diabetes mellitus (DM). Disorders of leukocyte profile have been associated with DM pathogenesis and complications. Objective : To investigate the differential leukocyte count in patients with type 2 diabetes treated with diabetic vascular leg exercises. Methods : A re-experimental study design P with a one-group pre-test-post-test design was used in the study, which was conducted on people with DM in Bengkulu Tengah. Blood plasma specimen collection before (30 samples) and after (30 samples) diabetic vascular leg exercise. The leukocyte diffcount was analyzed microscopically. Results : There were significant differences in segmented neutrophils (p = 0.013), lymphocytes (p = 0.029), monocytes (0.043) in people with diabetes before and after diabetes exercise intervention. There was no significant difference in basophils (p = 1,000), eosinophils (p = 0.594), stem neutrophils (p = 0.236) in people with diabetes before and after the diabetes exercise intervention. Conclusion : diabetes physical exercise modulates leukocyte count differential in people with type 2 DM in Central Bengkulu. The results of the study support the development of diabetes physical exercise as a therapeutic modality for DM patients to prevent complications from a young age.
 
 

The Anterolateral Thigh Perforator Flap is a Versatile Resource for Reconstructive Surgery

The Aim of Work: The aim of this study was to increase the efficiency of reconstruction of extensive soft-tissue defects of various localizations by differentiated use of the anterolateral thigh (ALT) perforator flap. Methods: We have retrospectively reviewed 39 patients, who had undergone soft-tissue reconstruction using pedicled and free transposition of ALT flaps. Results: In this series, all cases ended with a complete recovery of patients with adequate restoration of integumentary tissues. In the postoperative course, we encountered complications during free flap transplantation in nine cases (23%), two of which were associated with arterial insufficiency (5.1%) and seven – with venous thrombosis (17.9%). Most of these complications were not critical, and the problem was resolved by conservative treatment; in two cases, partial tissue death required a secondary suture. In three cases (7.7%), the complications were critical and led to the loss of the flap. Conclusions: The unprecedented versatility and the minimal trauma of the donor area make the ALT perforator flap one of the most demanded skin flaps. Despite the variable vascular anatomy, the ALT flap is the most adaptable plastic resource for extensive soft-tissue coverage of abdominal, perineal, and hip joints as a transposition flap on the vascular leg and for closing distant defects in any area of the body using it as a free microsurgical transplant. Other advantages include its variability in size and the ability to harvest multiple tissue components in different combinations depending on the desired outcome.

Inadequacies of Physical Examination in Patients with Acute Lower Limb Ischemia Are Associated with Dreadful Consequences

Acute lower limb ischemia (ALI) is limb and life-threatening. The aim of this study was to explore the association between adherence to guidelines on clinical diagnosis of ALI and outcome at 1 year. The hypothesis was that that better examination was associated with favorable outcome in ALI patients. Retrospective cohort study between 2015 and 2018. In-hospital, operation, radiological and autopsy registries captured 161 citizens of Malmö with ALI. The initial bedside evaluation was performed by an emergency physician. Scoring was based on evaluation of the 6 "Ps" and 1 point was given for pain, pallor, pulselessness, perishing cold, paresthesia, paralysis or ankle-brachial pressure index (ABI). The performance was scored (range 0-7), and a score ≥5 was defined as a satisfactory vascular leg status. A multivariate logistic regression was performed to adjust for confounders and expressed in Odds Ratios (OR) with 95% confidence intervals (CI). A satisfactory first clinical examination was performed in 55.3% of the patients. Measurement of ABI (OR 0.25, 95% CI 0.11-0.55), performing complete pulse status (OR 0.41, 95% CI 0.20-0.85), evaluating paralysis (OR 0.43, 95% CI 0.20-0.89), and a bedside score ≥5 points (OR 0.48, 95% CI 0.23-0.97) were independently associated with reduced risk of major amputation/mortality at 1-year follow up. Quality of initial bedside evaluation in patients with ALI was unsatisfactory to a large extent and better clinical examinations were associated with favorable outcome at 1 year. Skills in clinical diagnostics in ALI needs to be much improved.

Use of a flowable wound matrix to treat lower limb vascular ulcers.

This study is aimed at assessing the safety and effectiveness of an advanced flowable wound matrix (FWM) in the treatment of hard-to-heal vascular leg ulcers that often involve deep structures, are irregular and/or tunnelled or excavated. Records of patients seen at our Vascular Surgery Unit, at the University of Campania 'Luigi Vanvitelli', for hard-to-heal vascular leg ulcers between January 2018 and January 2020 were retrospectively reviewed. For each wound aetiology, area and complications were recorded and evaluated. Every patient received one or more applications of FWM and was followed up. A total of 22 patients (18 female/four male), mean age 63±8.5 years, were treated. The initial wound area ranged from 4-58cm2. After wound bed preparation, FWM was applied. Treatment was well tolerated and effective-rate of complications was low, graft take was very satisfactory, and no graft loss, rejection or superimposed infections were observed. Healing time was short: 85% of ulcers healed after 12 weeks. Most importantly, there was a decrease in the rate and level of amputations as compared with standard wound care. The data presented indicate that FWM is an option for the treatment of hard-to-heal vascular leg ulcers, particularly for those with an irregular cavity. The authors have no conflicts of interest.

Efficacy and Safety of a Hyaluronic Acid–Containing Cream in the Treatment of Chronic, Venous, or Mixed-Origin Leg Ulcers: A Prospective, Multicenter Randomized Controlled Trial

Topical applications of hyaluronic acid (HA)-containing formulations, based on the complex and vital role of HA in all stages of the wound-healing process, are routinely used with standard therapy to promote faster healing of chronic wounds. However, evidence to guide clinical decisions on the use of topical HA in the healing of vascular leg ulcers is limited. This study compared the efficacy and safety of topical application of a hyaluronic acid cream vs a neutral comparator (identical cream without HA) in treating subjects with chronic leg ulcers of vascular origin. This was a prospective, multicenter double-blind randomized controlled trial. One hundred sixty-eight subjects with chronic leg ulcers of venous or mixed (venous and arterial) origin were randomized to receive either topical applications of 0.2% HA cream or neutral comparator cream for a maximum of 20 weeks. The primary efficacy endpoint was complete ulcer healing (100% reepithelialization of the wound area centrally assessed at 20 weeks or before and confirmed 3 weeks later). In both groups, topical treatment was associated with standard therapy (ulcer cleansing and optimized compression). The proportion of subjects with centrally assessed complete healing of the target ulcer that was confirmed 3 weeks later (primary efficacy endpoint) was substantially higher in the HA cream group (31.3%) than in the neutral cream group (14.8%; P =.009). Results in the full analysis, per protocol, and as assessed by the investigator were consistent with primary results. No significant difference in treatment effect was observed when subjects were stratified according to baseline ulcer size (≤20 cm2 or >20 cm2) regardless of topical treatment. Safety and tolerability were comparable between treatments. Treatment of subjects with chronic leg ulcers of venous or mixed origin with HA cream is safe, well tolerated, and results in a higher rate of healing than a neutral comparator cream.

Efficacy and Safety of a Hyaluronic Acid-Containing Gauze Pad in the Treatment of Chronic Venous or Mixed-Origin Leg Ulcers: A Prospective, Multicenter, Randomized Controlled Trial

Introduction. Hyaluronic acid (HA)-containing formulations routinely are utilized along with standard therapy to promote faster healing of chronic wounds; evidence to guide clinical decisions on the use of topical HA in the healing of vascular leg ulcers is limited. Objective. This study compared the efficacy and safety of an HA-impregnated gauze pad with an identical gauze pad without HA in the treatment of chronic leg ulcers of vascular origin. Materials and Methods. A prospective, multicenter, multinational, parallel-group, randomized, double-blind, clinical study was conducted between June 13, 2017, and December 31, 2018. Adults with 1 or more chronic leg ulcers of venous or mixed origin between 2 months and 4 years’ duration were eligible to participate. Participants were randomized to treatment consisting of standard care (ie, ulcer cleansing, debridement/anesthesia as necessary, and optimized compression) and either application of a gauze pad containing 0.05% HA or a neutral comparator once daily for a maximum of 20 weeks. The primary efficacy endpoint was complete ulcer healing (100% reepithelialization of the wound area centrally assessed by 1 independent and experienced assessor blinded with respect to the treatment applied, as shown on digital photographs taken under standardized conditions at or before 20 weeks and confirmed 3 weeks later). Secondary efficacy endpoints included the percentage of completely healed target ulcers, residual area of target ulcer relative to baseline, the condition of the periulcerous skin, the total amount of analgesics used, the incidence of infection at the ulcer site of the target ulcer, patient adherence to treatment, time to achieve complete healing as centrally assessed, and pain intensity as measured by a visual analog scale. Results. Among the 168 participants (82 in the HA gauze pad group and 86 in the neutral gauze pad group), 33 (39.8%) in the HA group experienced complete healing of the target ulcer, which was significantly higher than the neutral comparator group (15, 18.5%; P = .002). Results in the full analysis and per-protocol sets were consistent with the primary results; no significant difference was noted in outcomes when participants’ wounds were stratified according to baseline ulcer size. Conclusions. HA delivered in a gauze pad formulation could be a beneficial treatment for chronic leg ulcers of venous or mixed origin.

The Impact of COVID-19 Pandemic on Vascular Leg Ulcers.

The aim of this study was to evaluate the impact of 2 lockdown periods during coronavirus disease 2019 (COVID-19) on the course and management of nonhealing vascular ulcers of lower limbs. A total of 41 patients were included in the study. Before the pandemic began they had been seen at our unit at weekly intervals. During lockdown from March 9, 2020, to May 18, 2020 subjects were not allowed to enter the hospital unless they needed urgency or emergency surgery, or oncological management. During the second lockdown, from October 19, 2020, to December 11, 2020 patients could be followed up at distance by direct outreach including telephoning contacts. Data obtained early after each lockdown were compared with those obtained prior to the pandemic. Data for the first lockdown show that pain intensified and there was an increase in the recurrence rate of wounds, of their severity, and of superimposed infections as compared with the prelockdown period. The risk of lower-limb amputation was also considerably greater. During the second and less restrictive lockdown, patients were followed up by telemedicine and data indicate that skin lesions had not worsened any further. The management of vascular wounds was impacted by the pandemic unfavorably with health care failures in the hospital as well as in the primary care settings. In conclusion, the treatment of vascular leg ulcers is challenged by the COVID-19 pandemic as this spreads worldwide. This seems to be in keeping with what happens for other diseases. The data we obtained indicate that the pandemic-related lockdown has a deleterious effect on vascular skin wounds, with an increase of severity and mortality risk. The impact appears to be proportional to the number and the degree of limitations imposed on people.

Clinical-ultrasound and clinical-morphological characteristics of adnexal torsion in girls and adolescents

Clinical-ultrasound and clinical-morphological characteristics of adnexal torsion to the improvement of early diagnosis and development of optimal ways of organ-preserving surgical tactics of treatment have been determined. An analysis was carried out of 71 patients with adnexal torsion (group 1– 30 girls of 2–12 years, group 2 – 41 adolescents of 13–17 years). The main clinical signs of adnexal torsion were nonspecific and similar to the well-known clinic of acute abdomen. Ultrasound examination with color doppler mapping (CDM) allowed to suspect adnexal torsion in 44 (62 %) patients. The main echographic features of adnexal torsion were: ovarian enlargement, non-typical location and a change in the structure of ovary, the presence of a free liquid in the cavity of a small pelvis or in the abdominal cavity, «a symptom of springs» (a twisted vascular leg), a decrease or absence of blood flow in CDM. The torsion of intact uterine appendages is installed in 29 patients (twice as often in group 1). In 42 cases were detected the torsion of the uterine appendages, compromised by the presence of tumors and tumor-like formations (twice as often in group 2). In both groups, 36 (50.7 %) organ-preserving and 35 (49.3 %) radical operations were carried out. According to the results of morphological examination of the removed tissues, the following data were obtained: follicular cysts – 15, paratubal cysts – 8, corpus luteum cysts – 8, teratomas – 5, serous cystadenomas – 2, mucinous cystadenoma – 1, paraovarian cysts – 3. Differential diagnosis of adnexal torsion in girls and adolescents should include a thorough collection of anamnestic data, taking into account the features of the clinical course of the disease, the results of a comprehensive examination with an assessment of ultrasound data from CDM, computer and magnetic resonance imaging, which will contribute to the advanced adequate selection of tactics of urgent gynecological intervention. The method of choice for the treatment of adnexal torsion is a minimally invasive surgical intervention – a laparoscopy with organ-preserving operations. Keywords: adnexal torsion, girls, ultrasound and morphological characteristics.

A new wound in an old burn scar: a guide to Marjolin's ulcers for primary care.

Marjolin’s ulcers are a cutaneous squamous cell carcinoma (SCC) found in tissue that has been previously traumatised and subsequently healed, such as chronic wounds, including diabetic or vascular leg ulcers, or an old burn scar. There is a long latent period (which can be over 30 years) from original insult to malignant transformation, and risk of malignancy varies depending on type of wound but is estimated to occur in 0.5% of vascular ulcers and 1%–2% of burn scars.1,2 This article discusses a case referred from general practice to the authors’ UK burns centre with a new non-healing wound in a previously completely healed scar, more than 40 years after initial burn. A 56-year-old female presented with a 65 × 30 mm lesion in the right axilla in the scar of a flame injury that had occurred 48 years earlier. The wound had appeared spontaneously 2 years previously and enlarged and progressed over 6 months to a non-healing ulcer, causing itching, pain, and intermittent bleeding. There was …

Use of Porcine-Derived Dermal Substitutes for Treatment of Nonhealing Vascular Leg Ulcers: A Case Series.

Nonhealing leg ulcers are a major health problem worldwide with a high economic burden since they require human and material resources. Moreover, nonhealing ulcers are a major nontraumatic cause of lower limb amputations. Dermal substitutes have emerged as an effective therapeutic option for treatment of skin lesions, but data on leg ulcers are scarce. We evaluated safety and efficacy of a porcine-derived dermal substitute in the treatment of chronic vascular leg ulcers. Records of patients with nonhealing ulcers seen at our unit from 2018 to 2019 were retrospectively reviewed. Wound etiology, wound area, and complications were evaluated. Each patient received one application of porcine-derived dermal substitute and was followed-up. Six patients (5 females and 1 male) with a mean age of 61.3 (52-81) years presented with nonhealing leg ulcers. After surgical debridement and wound bed preparation, porcine-derived dermal substitute was applied onto the ulcer. Granulation was satisfactory within 10 days. All wounds healed after an average time of 14 weeks. Graft take was good, and no graft loss, rejection, or associated infection were observed. In conclusion, the data presented indicate that dermal substitutes are safe and effective for treatment of chronic nonhealing vascular leg ulcers.

The Detection of Wound Infection by Ion Mobility Chemical Analysis.

Surgical site infection represents a large burden of care in the National Health Service. Current methods for diagnosis include a subjective clinical assessment and wound swab culture that may take several days to return a result. Both techniques are potentially unreliable and result in delays in using targeted antibiotics. Volatile organic compounds (VOCs) are produced by micro-organisms such as those present in an infected wound. This study describes the use of a device to differentiate VOCs produced by an infected wound vs. colonised wound. Malodourous wound dressings were collected from patients, these were a mix of post-operative wounds and vascular leg ulcers. Wound microbiology swabs were taken and antibiotics commenced as clinically appropriate. A control group of soiled, but not malodorous wound dressings were collected from patients who had a split skin graft (SSG) donor site. The analyser used was a G.A.S. GC-IMS. The results from the samples had a sensitivity of 100% and a specificity of 88%, with a positive predictive value of 90%. An area under the curve (AUC) of 91% demonstrates an excellent ability to discriminate those with an infected wound from those without. VOC detection using GC-IMS has the potential to serve as a diagnostic tool for the differentiation of infected and non-infected wounds and facilitate the treatment of wound infections that is cost effective, non-invasive, acceptable to patients, portable, and reliable.

Identification of Prognostic Biomarkers of Adipose-Derived Stem Cells Treatment in Non-healing Vascular Leg Ulcers

Introduction - Autologous adipose tissue-derived stem cells (ASCs) has shown great potential in wound healing for patients not responder to gold standard tratment1-2. However, with easier isolation and better availability ASCs have sparked great clinical and research interest 3. The aim of our study is to identify biomarkers predictive of successful cell treatment in non healing vascular leg ulcers (VLU) using a reproducible technical approach verified in parallel with a deep lab cell characterization. Methods - From an initial cohort of 38 patients, 16 patients affected by non healing VLUs were randomized respectively to gold standard treatment (control arm,5 men 3 women) and to gold standard treatment plus ASCs (experimental arm, 5 men 3 women) sampling according to Coleman's technique4. The sample was centrifuged at 1300 r / min for 3 minutes and injected with an 18 G needle into the edges and into the bed of ulcer. A sample of lipoaspirate was sent simultaneously to the laboratory where it was appropriately treated for FVS extraction5. The cells are incubated with different monoclonal antibodies in order to quantify and characterize the different stem cells present (CD45-CD34 +, CD34 + CD146 +/- etc.). The next step involved the evaluation of cellular clonogenicity to estimate in vitro the number of aggregated fibroblasts (Unit Forming Colonies, CFU-F). The different immunophenotypical and functional characteristic of the harvested ASCs were correlated with clinical outcomes respectively: healing time, pain measured by NRS scale, Margolix index (MI)6, complete healing. Results - No major adverse events were recorded. The healing process was significantly faster by applying ASCs, 17.5± 7.0 weeks vs 24.5 ± 4.9 weeks recorded in the control arm (p<0.036). NRS dropped after the first week to 2.7 ± 2.0 in the experimental arm vs 6.6 ± 3.0, in the controls (p < 0.01). The MI was not significantly different between arms. Very interestingly we found a strong reverse correlation between the % of CD34+/CD45- cells respectively with the healing time (r= -0.894, p<0.041) and NRS (r=-0.934, p<0.020). Moreover, the in vitro expanded non hematopoietic progenitor (expressed as a N° of CFU-F) present an inverted correlation with the healing time (r=-0.868, p<0.057) while a significant correlation with NRS (r=-0.883, p<0.047) (Fig.1). There was also a positive correlation between the MI and the % of the CD34+ cells (r = 0.94 p < 0.005). The relationship between the MI and % of CFU-F is significantly associated (r=0.97 p < 0.002), as is also the correlation between MI with the total number of calculated CFU-F reinfused (r=0.98 p < 0.002). Finally, the number of pericytes described as the % of CD146+/CD271-CD45 low cells correlate significantly with the MI (r = 0.98 p < 0.002). Conclusion - The percentage % of CD34+/CD45- cells seems a predictive biomarker of successful ASCs treatment in these patients.

Photodynamic therapy in infected venous and mixed leg ulcers: a pilot experience.

To assess the tolerability and efficacy of photodynamic therapy (PDT) with RLP068, a novel phthalocyanine-derived photosensitiser, in controlling the bacterial load in different leg ulcers, due to vascular pathophysiology. An observational study of patients with infected leg ulcers of different pathophysiology, admitted to the hospital for a skin grafting procedure, were included. All patients underwent two sessions of PDT at time zero and after 72 hours. A semi-quantitative swab was taken before and 30 minutes after both sessions of PTD. During the time interval between the two treatments the ulcer was covered with foam dressing and compression therapy was applied to all patients. No systemic or topical antibiotics were administered. Statistical analysis of results was performed. A total of 36 patients (13 males, 23 females; aged 72.4±8.6 years, range: 55-85 years) were recruited; two had ulcers on both legs. PDT was shown to be effective in reducing bacterial load after the first treatment. Before the second PDT treatment (72 hours after first PDT treatment), a slight increase of the bacterial load was observed in all ulcers. However, after the second PDT session, bacterial swab results were negative in all but two ulcers. The procedure was well tolerated in all but four patients, who reported a very severe pain at baseline, which increased during treatment. In this study, PDT was effective in reducing bacterial load in patients with infected vascular leg ulcers, and allowed successful skin grafting to take place in all patients. The treatment was generally well tolerated. Studies with a greater number of patients and a control group are planned to confirm these results.

Correction: Iron deficiency associates with deterioration in several symptoms independently from hemoglobin level among chronic hemodialysis patients.

[This corrects the article DOI: 10.1371/journal.pone.0201662.].

SKIN-MUSCULAR FLAP OF MAJOR PECTORALIS MUSCLE IN PHARYNGOSTOMAS PLASTIC CLOSURE

Laryngeal and hypopharyngeal cancer accounts for 1.5–3.8% of all malignant neoplasms, accounting for more than half of all ENT-cancer patients in the structure of oncological morbidity in Ukraine. Among them more than 60% are found in III–IV stages. Locally diffused larynx and hypopharynx cancer are indications for laryngectomy and resection of the hypopharynx, depending on the extent of the lesion that, in the presence of regional metastases, can be combined with one-or two-way radical or functional neck dissection. Failure to suture the hypopharynx after laryngectomy further leads to the formation of pharyngeal fistulas, suppurations of postoperative wounds, necrosis of the skin and the formation of pharyngostomas. In the plastic closure of the pharyngostomes, regional skin, and facial, and skin-muscle flaps are used, among which the most common is the large chest muscle. The advantages of the flap are the ease of fence, the large volume of plastic material, stability of a “vascular leg”, reliability and short operating time. Our experience with the use of free and regional flap suggests that the musculo-skeletal system of the large chest muscle can be used not only as a “rescue swaddle”, but also, as a first choice in certain clinical situations. 72 patients with laryngeal and hypopharyngeal cancer were included to the study. The age of patients ranged from 41 to 74 years. All patients (100%) had histologically confirmed flat-cell carcinoma of varying degrees of differentiation. Depending on the spread of the cancer process, stage III (T3N0-1M0) was diagnosed in 47 (65.2%), stage IV (T3N2-3M0, T4N0-3M0) in 25 (34.8%) patients. Laryngeal cancer is found in 52 (72.2%), hypopharyngeal — in 20 (27.8%) patients. Plastic closure of pharyngostomas was carried out after 2–3 months after larynectomy, after reduction of inflammation in postoperative wound and clear formation of pharyngostoma edges. The surgical intervention was carried out by two brigades — one brigade carried out the excision of the skin muscle flap, while the other one carried out the removal of the throat wall in the soft tissues of the neck, and then the sheathing of the skin part of the flap was carried out to the edges of the pharyngostomas, and the stitching of the edges of the skin at the point of excision of the flap on the chest wall. The evaluation of the function was performed on the scale of functioning for head and neck cancer patients, PSS-HN (Performance Status Scale for Head and Neck Cancer Patients). The total necrosis of the flap was observed in 2 patients (2.7%) among 72, that were operated as one of the first, at the stage of development of the surgical technique. Partial flap necrosis was observed in 6 (8.3%) patients. Thus, the plastic closure of pharyngostomas with the help of the skin-mimetic flap of the big chest muscle was successful in the vast majority of patients (70 out of 72). The investigation of the functional status of patients on the PSS-HN scale showed a significant improvement and expansion of the diet from 30 to 90-100 points due to the transfer of patients from probe to usual food intake. The public eating habits improved from 25 to 100 points. The operation of the plastic closure of pharyngostomas did not increase the clarity of the language of patients, but created the anatomical conditions for the development of pseudo-voice and vocal prosthesis. So, the using of the skin-muscular flap of major pectoralis muscle in pharyngostomas plastic closure allows achieving satisfactory surgical and functional results.

New biochip immunofluorescence test for the serological diagnosis of pemphigus vulgaris and foliaceus: A review of the literature.

The immunoassays that are available for the serological diagnosis of the more common subtypes of autoimmune blistering diseases such as pemphigus vulgaris (PV) and pemphigus foliaceus (PF) include enzyme-linked immunosorbent assay (ELISA) testing to specific antigens desmoglein (Dsg)1 and Dsg3, direct immunofluorescence (DIF), indirect immunofluorescence (IIF), and immunoblotting. A review of the literature on the biochip assay was conducted. Six studies investigated the validity of a new biochip, mosaic-based, IIF test in patients with pemphigus and demonstrated its relatively high sensitivity and specificity (Dsg3: 97.62-100%, 99.6-100%; Dsg1: 90%, 100%) in comparison with ELISA (Dsg3: 81-100%, 94-100%; Dsg1: 69-100%, 61.1-100%), and/or IIF (PV: 75-100%, 91.8-100%; PF: 67-100%) using suitable substrates. So far, validation studies of the biochip have been conducted in four countries (Germany, Italy, Turkey, and Poland) but none in the southern hemisphere. Caucasian patients were recruited as normal controls for these studies; thus, the diagnostic value of the biochip remains uncertain in population groups of other ethnicities. A range of disease control patients were recruited including patients with linear immunoglobulin A dermatosis, psoriasis, discoid lupus erythematosus, lichen planus, and noninflammatory skin diseases (e.g., squamous cell carcinoma, basal cell carcinoma, and vascular leg ulcers). Prospective studies with control patients from a diverse range of ethnicities are needed to better validate the biochip.

No Sting Barrier Film to Protect Skin in Adult Patients: Findings From a Scoping Review With Implications for Evidence-Based Practice.

In the industrialized world, approximately 1-1.5% of the population has received treatments for skin lesions. In the 1990s, a polymeric barrier film called the No Sting Barrier Film (NSBF) was developed as an alternative to petrolatum-based ointments and zinc oxide formulas. To date, few studies have explored the effectiveness of NSBF in protecting skin integrity. To map the methods, fields and outcomes used to produce evidence on NSBF effectiveness. A scoping review was performed in 2015. A search strategy for identifying relevant studies was designed and performed. Systematic reviews, meta-analyses, randomized controlled trials, controlled clinical trials, and comparative studies for all types of interventions were included; research conducted in any clinical context was eligible for inclusion. Studies were selected by two reviewers; data extraction and analysis also was performed by two reviewers and disagreements were discussed. Six studies were included. NSBF's potential as a skin protector was investigated with respect to (a) chronic wounds (pressure ulcers or vascular leg ulcers); (b) urinary or fecal incontinence; and (c) post-mastectomy irradiation. The principal clinical outcomes investigated were, respectively: (a) wound healing, wound exudates and erythema control; (b) incidence of incontinence-associated dermatitis and skin reactions; and (c) intensity of pruritus and skin reactions. Pain and comfort were measured in all clinical applications. The main process outcomes investigated were: (a) ease of application, (b) application and removal time, and (c) costs. Zinc oxide and petroleum formulations were the most common comparison interventions in research on chronic ulcers and incontinence; sorbolene cream and topical corticosteroids were the most frequent comparisons in the context of post-mastectomy irradiation. NBSF may be used for peri-wound skin protection in patients with chronic wounds, with urinary or fecal incontinence and for women undergoing post-mastectomy irradiation. However, more robust experimental studies are needed in all clinical fields where NBSF is applied.

Effect of a wound cleansing solution on wound bed preparation and inflammation in chronic wounds: a single-blind RCT.

Research into surfactant solutions for the debridement of chronic wounds suggests that surfactants may support wound bed preparation (WBP) in chronic wounds, however their efficacy has not been evaluated in randomised controlled trials (RCTs). Our aim was to assess the clinical efficacy of a propylbetaine-polihexanide (PP) solution versus normal saline (NS) solution in WBP, assessing inflammatory signs and wound size reduction in patients with pressure ulcers (PUs) or vascular leg ulcers. In a single-blinded randomised controlled trial (RCT) patients were randomly allocated to two groups and treated with either propylbetaine-polihexanide (PP) solution (Prontosan) or NS. Wounds were assessed using the Bates-Jensen wound assessment tool (BWAT). Assessments took place at inclusion (T0), day 7 (T1), day 14 (T2), day 21 (T3), and day 28 (T4). Outcomes were analysed using a two-tailed Student's t-test. A total of 289 patients were included. Both groups had similar demographics, clinical status, and wound characteristics. Data analysis showed statistically significant differences between T0 and T4 for the following outcomes: BWAT total score, p=0.0248; BWAT score for inflammatory items, p=0.03; BWAT scores for wound size reduction (p=0.049) and granulation tissue improvement (p=0.043), all in favour of PP. The assessment of pain did not show any significant difference between the two groups. The study results showed significantly higher efficacy of the PP solution versus NS solution, in reducing inflammatory signs and accelerating the healing of vascular leg ulcers and PUs. This evidence supports the update of protocols for the care of chronic wounds. The authors have no conflict of interest regarding this research. This is an investigator initiated trial. B. Braun Milano SpA kindly provided the material under investigation for both treatment groups, and paid the Ethics Committees' application fees in all participating centres.

ROLE OF VASCULAR FACTOR IN THE PATHOGENESIS OF REMOTE CONSEQUENCES OF DEFORMING ARTHROSIS OF THE ANKLE JOINT

A comprehensive assessment of hemodynamics of blood vessels, lower leg in patients at different times, the late period of deformative arthrosis of the ankle joint (DAGS) according to the gravity, which allows to predict its course, outcomes and identify the occurrence of complications were carried out. Dynamic monitoring of patients contributed to the high efficiency of the differentiated approach to the management of each category of patients in the long term DAGS was made. The authors have obtained information that the outcome depends on the violation of vascular autoregulation leg hemodynamics in different periods of deforming arthrosis of the ankle joint of any severity. Identified data provide an opportunity to optimize a differentiated approach in the treatment of patients with distant periods of follow-up monitoring.