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1.
Clin Geriatr Med ; 40(3): 459-470, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38960537

ABSTRACT

The physical, emotional, and financial toll of acute and chronic nonhealing wounds on older adults and their caregivers is immense. Surgical treatment of wounds in older adults can facilitate healing but must consider the medical complexity of the patient, the patient's desires for treatment and the likelihood of healing. Innovative approaches and devices can promote rapid healing. By using a team approach, from preoperative planning to postoperative care, with a focus on the needs and desires of the patient, successful outcomes with improved patient satisfaction are possible even in medically complex patients.


Subject(s)
Wound Healing , Wounds and Injuries , Humans , Aged , Wounds and Injuries/surgery , Wounds and Injuries/therapy , Aged, 80 and over
2.
ACS Pharmacol Transl Sci ; 7(1): 18-27, 2024 Jan 12.
Article in English | MEDLINE | ID: mdl-38230290

ABSTRACT

Understanding the complex interplay of pro-inflammatory and anti-inflammatory cytokines is crucial in the field of wound healing, as it holds the key to developing effective therapeutics. In the initial stages of wound healing, pro-inflammatory cytokines like IL-1ß, IL-6, TNF-α, and various chemokines play vital roles in recruiting cells for debris clearance and the recruitment of growth factors. Careful regulation and timely resolution of this early inflammation are essential for optimal wound repair. As the healing process progresses, anti-inflammatory proteins such as IL-10 and IL-4 become instrumental in facilitating the transition to later stages where pro-inflammatory cytokines promote angiogenesis and wound remodeling. This Perspective underscores the complexity of inflammatory cytokines in wound healing research and emphasizes the need for comprehensive and unbiased methodologies in their evaluation. For robust and reliable results in wound-healing research, a more holistic approach is necessary-one that considers the roles, interactions, and timing of biological molecules, alongside careful sampling and evaluation strategies.

3.
Wound Repair Regen ; 32(1): 6-33, 2024.
Article in English | MEDLINE | ID: mdl-37970711

ABSTRACT

The major populations at risk for developing pressure ulcers are older adults who have multiple risk factors that increase their vulnerability, people who are critically ill and those with spinal cord injury/disease. The reported prevalence of pressure ulcers in the United States is 2.5 million. However, this estimate is derived from acute care facilities and does not include people who are living at home or in nursing facilities. Despite the implementation of hospital and facility-based preventive measures, the incidence of pressure ulcers has not decreased in decades. In addition to the burden of pain, infection and death, it is estimated that hospital-acquired pressure ulcers cost the health system $26.8 billion annually with over 50% of the cost attributed to treating Stage 3 and 4 pressure injuries. Thus, it is critical to examine the literature and develop guidelines that will improve the outcomes of this complex and costly condition. This guideline update is a compendium of the best available evidence for the treatment of Pressure Ulcers published since the last update in 2015 and includes a new section based on changing demographics entitled 'Palliative wound care for seriously ill patients with pressure ulcers'. The overall goal of the Wound Healing Society Guideline project is to present clear, concise and commercial free guidelines that clinicians can use to guide care, that researchers can use to develop studies that will improve treatment and that both clinicians and researchers can use to understand the gaps in our knowledge base.


Subject(s)
Pressure Ulcer , Humans , Aged , Pressure Ulcer/epidemiology , Pressure Ulcer/therapy , Pressure Ulcer/etiology , Wound Healing , Risk Factors , Prevalence
4.
Br J Dermatol ; 190(3): 392-401, 2024 Feb 16.
Article in English | MEDLINE | ID: mdl-37952167

ABSTRACT

BACKGROUND: Pyoderma gangrenosum (PG) is a rare ulcerative skin condition with no current standardized outcomes or outcome measures. With a rich investigational therapeutic pipeline, standardization of outcomes and improvement of data quality and interpretability will promote the appropriate and consistent evaluation of potential new therapies. Core outcome sets (COS) are agreed, standardized sets of outcomes that represent the minimum that should be measured and reported in all clinical trials of a specific condition. OBJECTIVES: To identify and reach a consensus on which domains (what to be measured) should be included in the Understanding Pyoderma Gangrenosum: Review and Analysis of Disease Effects (UPGRADE) core domain set for clinical trials in PG. METHODS: Collaborative discussions between patients and PG experts, and a systematic review of the literature identified items and prospective domains. A three-round international eDelphi exercise was performed to prioritize the domains and refine the provisional items (consensus: ≥ 70% of participants rating a domain as 'extremely important' and < 15% of participants voting 'not important'), followed by an international meeting to reach consensus on the core domain set (consensus: < 30% disagreement). Item-generation discussions and consensus meetings were hosted via online videoconferences. The eDelphi exercise and consensus voting were performed using Qualtrics survey software. Participants were adults with PG, healthcare professionals, researchers and industry representatives. RESULTS: Collaborative discussions and systematic reviews yielded 115 items, which were distilled into 15 prospective domains. The eDelphi exercise removed the three lowest-priority domains ('laboratory tests', 'treatment costs' and 'disease impact on family') and ranked 'pain', 'quality of life' and 'physical symptoms' as the highest-priority prospective domains. Consensus was reached on the domains of 'pain', 'quality of life' and 'clinical signs'. The domain of 'disease course/disease progression' narrowly failed to reach consensus for inclusion in the core set (32% of participants voted 'no'). Refinement of this domain definition will be required and presented for consideration at future consensus meetings. CONCLUSIONS: The UPGRADE core domain set for clinical trials in PG has been agreed by international multistakeholder consensus. Future work will develop and/or select outcome measurement instruments for these domains to establish a COS.


Subject(s)
Pyoderma Gangrenosum , Adult , Humans , Treatment Outcome , Pyoderma Gangrenosum/diagnosis , Prospective Studies , Outcome Assessment, Health Care , Pain , Delphi Technique , Research Design
5.
J Invest Dermatol ; 144(6): 1295-1300.e6, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38110114

ABSTRACT

At present, there are no standardized guidelines for determining patient eligibility for pyoderma gangrenosum (PG) clinical trials. Thus, we aim to determine which clinical features, histopathological features, or laboratory features should be included in active ulcerative PG clinical trial eligibility criteria for treatment-naïve patients and patients already treated with immunomodulating medications (treatment-exposed patients). This study employed 4 rounds of the Delphi technique. Electronic surveys were administered to 21 international board-certified dermatologists and plastic surgeon PG experts (June 2022-December 2022). Our results demonstrated that for a patient to be eligible for a PG trial, they must meet the following criteria: (i) presence of ulcer(s) with erythematous/violaceous undermining wound borders, (ii) presence of a painful or tender ulcer, (iii) history/presence of rapidly progressing disease, (iv) exclusion of infection and other causes of cutaneous ulceration, (v) biopsy for H&E staining, and (vi) a presence/history of pathergy. These criteria vary in importance for treatment-naïve versus treatment-exposed patients. Given the international cohort, we were unable to facilitate live discussions between rounds. This Delphi consensus study provides a set of specific, standardized eligibility criteria for PG clinical trials, thus addressing one of the main issues hampering progress toward Food and Drug Administration approval of medications for PG.


Subject(s)
Clinical Trials as Topic , Consensus , Delphi Technique , Patient Selection , Pyoderma Gangrenosum , Humans , Pyoderma Gangrenosum/drug therapy , Pyoderma Gangrenosum/diagnosis , Eligibility Determination/standards , Skin Ulcer/etiology , Skin Ulcer/diagnosis , Skin Ulcer/pathology , Skin Ulcer/drug therapy , Biopsy , Skin/pathology , Skin/drug effects
6.
Arq. bras. oftalmol ; 87(1): e2021, 2024. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1527816

ABSTRACT

ABSTRACT Purpose: To evaluate the effect of tobacco smoking on trabeculectomy outcomes. Methods: Charts of patients with glaucoma who underwent trabeculectomy performed by a single surgeon between 2007 and 2016 were retrospectively reviewed. Charts were screened for a documented history of smoking status before surgery. Demographic and clinical preoperative variables were recorded. Based on smoking history, subjects were divided into two groups: smokers and nonsmokers. Any bleb-related interventions (e.g., 5-flourouracil injections ± laser suture lysis) or bleb revision performed during the postoperative period were noted. Success was defined as an intraocular pressure >5 mmHg and <21 mm Hg without (complete success) or with (qualified success) the use of ocular hypotensive medications. Failure was identified as a violation of the criteria mentioned above. Results: A total of 98 eyes from 83 subjects were included. The mean age of the subjects was 70.7 ± 11.09 years, and 53% (44/83) were female. The most common diagnosis was primary open-angle glaucoma in 47 cases (47.9%). The smokers Group included 30 eyes from 30 subjects. When compared with nonsmokers, smokers had a significantly worse preoperative best-corrected visual acuity (p=0.038), greater central corneal thickness (p=0.047), and higher preoperative intraocular pressure (p=0.011). The success rate of trabeculectomy surgery at 1 year was 56.7% in the smokers Group compared with 79.4% in the Group nonsmokers (p=0.020). Smoking presented an odds ratio for failure of 2.95 (95% confidence interval, 1.6-7.84). Conclusion: Smokers demonstrated a significantly lower success rate 1 year after trabeculectomy compared with nonsmokers and a higher requirement for bleb-related interventions.


RESUMO Objetivo: Avaliar o efeito do tabagismo nos desfechos da trabeculectomia. Métodos: Uma revisão retrospectiva do gráfico de pacientes com glaucoma submetidos à trabeculectomia foi realizada por um único cirurgião entre 2007 e 2016. Os gráficos foram examinados para uma história documentada de condição de fumante antes da cirurgia. Variáveis pré-operatórias clínicas e demográficas e clínicas foram registradas. Os pacientes foram divididos em dois grupos de acordo com sua história de tabagismo em fumantes e não fumantes. Quaisquer Intervenções relacionadas à bolha, por exemplo, injeções de 5-fluorouracil + lise de sutura com laser, ou revisão da bolha realizada durante o período pós-operatório foram observadas. O sucesso foi definido como pressão intraocular > 5 mmHg e < 21 mm Hg sem (sucesso completo) ou com (sucesso qualificado) medicamentos hipotensores oculares. A falha foi identificada como violação dos critérios mencionados acima. Resultados: O estudo incluiu 98 olhos de 83 pacientes com idade média de 70,7 ± 11,09 anos, sendo 53% (44/83) dos pacientes do sexo feminino. O diagnóstico mais comum foi o glaucoma de ângulo aberto primário com 47 casos (47,9%). O Grupo de fumantes incluiu 30 olhos de 30 pacientes. Os fumantes, quando comparados aos não fumantes, apresentaram uma melhor acuidade visual pré-operatória significativamente pior (p=0,038), maior espessura central da córnea (p=0,047) e maior pressão intraocular pré-operatória (p=0,011). A taxa de sucesso de um ano para a cirurgia de trabeculectomia foi de 56,7% no Grupo de fumantes contra 79,4% no Grupo de não fumantes (p=0,020). O tabagismo apresentou razão de chances para falha de 2,95 95% de IC (1,6-7,84). Conclusão: Os fumantes demonstraram uma taxa de sucesso significativamente menor em um ano após a trabeculectomia em comparação com os não fumantes e uma maior necessidade de intervenções relacionadas à bolha.

7.
Health Informatics J ; 29(4): 14604582231215867, 2023.
Article in English | MEDLINE | ID: mdl-37982397

ABSTRACT

We constructed a preventive social behaviours (PSB) Index using survey questions that were aligned with WHO recommendations, and used linear regression to assess the impact of reported COVID-19 deaths (RCD), people's confidence of government handling of the pandemic (CGH) and government stringency (GS) in the United Kingdom (UK) over time on the PSB index. We used repeated, nationally representative, cross-sectional surveys in the UK over the course of 41 weeks from 1st April 2020 to January 28th, 2021, including a total of 38,092 participants. The PSB index was positively correlated with the logarithm of RCD (R: 0.881, p < .001), CGH (R: 0.592, p < .001) and GS (R: 0.785, p < .001), but was not correlated with time (R: -0.118, p = .485). A multivariate linear regression analysis suggests that the log of RCD (coefficient: 0.125, p < .001), GS (coefficient: 0.010, p = .019), and CGH (coefficient: 0.0.009, p < .001) had a positive and significant impact on the PSB Index, while time did not affect it significantly. These findings suggest that people's behaviours could have been affected by multiple factors during the pandemic, with the number of COVID-19 deaths being the largest contributor towards an increase in protective behaviours in our model.


Subject(s)
COVID-19 , Humans , COVID-19/epidemiology , Pandemics , Cross-Sectional Studies , Social Behavior , United Kingdom/epidemiology , Government
8.
ACS Pharmacol Transl Sci ; 6(5): 783-801, 2023 May 12.
Article in English | MEDLINE | ID: mdl-37200810

ABSTRACT

In this paper, we review and analyze the commonly available wound healing models reported in the literature and discuss their advantages and issues, considering their relevance and translational potential to humans. Our analysis includes different in vitro and in silico as well as in vivo models and experimental techniques. We further explore the new technologies in the study of wound healing to provide an all encompassing review of the most efficient ways to proceed with wound healing experiments. We revealed that there is not one model of wound healing that is superior and can give translatable results to human research. Rather, there are many different models that have specific uses for studying certain processes or stages of wound healing. Our analysis suggests that when performing an experiment to assess stages of wound healing or different therapies to enhance healing, one must consider not only the species that will be used but also the type of model and how this can best replicate the physiology or pathophysiology in humans.

9.
Adv Skin Wound Care ; 36(5): 249-258, 2023 May 01.
Article in English | MEDLINE | ID: mdl-37079788

ABSTRACT

OBJECTIVE: Stage 3 and 4 pressure injuries (PIs) present an enormous societal burden with no clearly defined interventions for surgical reconstruction. The authors sought to assess, via literature review and a reflection/evaluation of their own clinical practice experience (where applicable), the current limitations to the surgical intervention of stage 3 or 4 PIs and propose an algorithm for surgical reconstruction. METHODS: An interprofessional working group convened to review and assess the scientific literature and propose an algorithm for clinical practice. Data compiled from the literature and a comparison of institutional management were used to develop an algorithm for the surgical reconstruction of stage 3 and 4 PIs with adjunctive use of negative-pressure wound therapy and bioscaffolds. RESULTS: Surgical reconstruction of PI has relatively high complication rates. The use of negative-pressure wound therapy as adjunctive therapy is beneficial and widespread, leading to reduced dressing change frequency. The evidence for the use of bioscaffolds both in standard wound care and as an adjunct to surgical reconstruction of PI is limited. The proposed algorithm aims to reduce complications typically seen with this patient cohort and improve patient outcomes from surgical intervention. CONCLUSIONS: The working group has proposed a surgical algorithm for stage 3 and 4 PI reconstruction. The algorithm will be validated and refined through additional clinical research.


Subject(s)
Crush Injuries , Pressure Ulcer , Humans , Pressure Ulcer/surgery , Surgical Wound Infection
10.
Wounds ; 35(3): 36-40, 2023 02.
Article in English | MEDLINE | ID: mdl-36877939

ABSTRACT

INTRODUCTION: Publications aimed at improving the quality of evidence in wound care clinical research have stressed the importance of minimizing study bias. In particular, lack of a universal definition of healing in wound studies leads to detection bias, resulting in noncomparable healing rates. OBJECTIVE: This report analyzes the steps taken to reduce the main sources of bias in a particular RCT (the HIFLO Trial) that evaluated healing in DFUs using microvascular tissue. MATERIALS AND METHODS: To address "definition of healing"-induced detection bias, 3 blinded adjudicators independently assessed each DFU using a rigorous 4-part definition of healing. Adjudicator responses were analyzed to assess reproducibility. Predefined criteria were also included to avoid bias owing to selection, performance, attrition, and reporting. RESULTS: Rigor and comparability across sites were ensured through investigator training, consistent SOC, data monitoring, and independent statistical and ITT-only analysis. The level of agreement among adjudicators was greater than or equal to 90% for each of the 4-part healing criteria. CONCLUSIONS: High-level agreement by blinded adjudicators confirmed that DFUs in the HIFLO Trial were consistently assessed for healing without bias, validating the most rigorous assessment criteria to date. The findings reported herein may prove beneficial for others seeking to minimize bias in wound studies.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Humans , Diabetic Foot/therapy , Reproducibility of Results , Wound Healing
11.
Arch Dermatol Res ; 315(4): 983-988, 2023 May.
Article in English | MEDLINE | ID: mdl-36305958

ABSTRACT

INTRODUCTION: Pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis that affects approximately 0.3-6 out of every 100,000 people worldwide. Clinical trials are scarce but there is growing interest in using newer and more targeted therapeutics to achieve disease remission. However, there are no standardized instruments to measure outcomes in PG and, therefore, future clinical trials are hampered by the absence of established and accurate means of assessment and comparison. Therefore, we aim to produce an internationally accepted core outcome set (COS) that will overcome this obstacle. This protocol outlines our intended approach to achieve the first part of this process, establishing a core outcome domain set. METHODS: An international team of PG stakeholders, consisting of physicians, wound care nurses, patients, scientists and industry representatives, has been assembled for the purpose of building a comprehensive and universally established set of core outcome domains. During the first step, we will generate items of relevance using a nominal process from all stakeholders. Items will be distilled and collapsed into potential domains and subdomains. A systematic review of current methods for reporting PG has already been published and domains identified in this work will be considered in the generation of the core domains set. During the second step, after the potential domains and subdomains are identified, stakeholders will participate in an e-Delphi exercise to rate the importance of (sub)domains. A final consensus meeting will be organized with the goal of establishing a core domain set. CONCLUSION: Pyoderma gangrenosum lacks an established COS and previously published clinical trials have used inconsistent measures established from similarly inconsistent domains. As a first step this study seeks to create a core domain set within the COS, to build the foundation for future core outcome work for PG.


Subject(s)
Pyoderma Gangrenosum , Humans , Pyoderma Gangrenosum/diagnosis , Pyoderma Gangrenosum/therapy , Treatment Outcome , Delphi Technique , Research Design , Consensus , Systematic Reviews as Topic
12.
Arq Bras Oftalmol ; 87(1): 0061, 2022.
Article in English | MEDLINE | ID: mdl-36169426

ABSTRACT

PURPOSE: To evaluate the effect of tobacco smoking on trabeculectomy outcomes. METHODS: Charts of patients with glaucoma who underwent trabeculectomy performed by a single surgeon between 2007 and 2016 were retrospectively reviewed. Charts were screened for a documented history of smoking status before surgery. Demographic and clinical preoperative variables were recorded. Based on smoking history, subjects were divided into two groups: smokers and nonsmokers. Any bleb-related interventions (e.g., 5-flourouracil injections ± laser suture lysis) or bleb revision performed during the postoperative period were noted. Success was defined as an intraocular pressure >5 mmHg and <21 mm Hg without (complete success) or with (qualified success) the use of ocular hypotensive medications. Failure was identified as a violation of the criteria mentioned above. RESULTS: A total of 98 eyes from 83 subjects were included. The mean age of the subjects was 70.7 ± 11.09 years, and 53% (44/83) were female. The most common diagnosis was primary open-angle glaucoma in 47 cases (47.9%). The smokers Group included 30 eyes from 30 subjects. When compared with nonsmokers, smokers had a significantly worse preoperative best-corrected visual acuity (p=0.038), greater central corneal thickness (p=0.047), and higher preoperative intraocular pressure (p=0.011). The success rate of trabeculectomy surgery at 1 year was 56.7% in the smokers Group compared with 79.4% in the Group nonsmokers (p=0.020). Smoking presented an odds ratio for failure of 2.95 (95% confidence interval, 1.6-7.84). CONCLUSION: Smokers demonstrated a significantly lower success rate 1 year after trabeculectomy compared with nonsmokers and a higher requirement for bleb-related interventions.

14.
Wound Repair Regen ; 30(2): 156-171, 2022 03.
Article in English | MEDLINE | ID: mdl-35130362

ABSTRACT

The Wound Healing Foundation (WHF) recognised a need for an unbiased consensus on the best treatment of chronic wounds. A panel of 13 experts were invited to a virtual meeting which took place on 27 March 2021. The proceedings were organised in the sub-sections diagnosis, debridement, infection control, dressings, grafting, pain management, oxygen treatment, outcomes and future needs. Eighty percent or better concurrence among the panellists was considered a consensus. A large number of critical questions were discussed and agreed upon. Important takeaways included that wound care needs to be simplified to a point that it can be delivered by the patient or the patient's family. Another one was that telemonitoring, which has proved very useful during the COVID-19 pandemic, can help reduce the frequency of interventions by a visiting nurse or a wound care center. Defining patient expectations is critical to designing a successful treatment. Patient outcomes might include wound specific outcomes such as time to heal, wound size reduction, as well as improvement in quality of life. For those patients with expectations of healing, an aggressive approach to achieve that goal is recommended. When healing is not an expectation, such as in patients receiving palliative wound care, outcomes might include pain reduction, exudate management, odour management and/or other quality of life benefits to wound care.


Subject(s)
COVID-19 , Wound Healing , COVID-19/therapy , Consensus , Humans , Pandemics , Quality of Life
15.
Clin Kidney J ; 15(1): 136-144, 2022 Jan.
Article in English | MEDLINE | ID: mdl-35035944

ABSTRACT

BACKGROUND: Calcific uraemic arteriolopathy (CUA; calciphylaxis) is a rare disease seen predominantly in patients receiving dialysis. Calciphylaxis is characterized by poorly healing or non-healing wounds, and is associated with mortality, substantial morbidity related to infection and typically severe pain. In an open-label Phase 2 clinical trial, SNF472, a selective inhibitor of vascular calcification, was well-tolerated and associated with improvement in wound healing, reduction of wound-related pain and improvement in wound-related quality of life (QoL). Those results informed the design of the CALCIPHYX trial, an ongoing, randomized, placebo-controlled, Phase 3 trial of SNF472 for treatment of calciphylaxis. METHODS: In CALCIPHYX, 66 patients receiving haemodialysis who have an ulcerated calciphylaxis lesion will be randomized 1:1 to double-blind SNF472 (7 mg/kg intravenously) or placebo three times weekly for 12 weeks (Part 1), then receive open-label SNF472 for 12 weeks (Part 2). All patients will receive stable background care, which may include pain medications and sodium thiosulphate, in accordance with the clinical practices of each site. A statistically significant difference between the SNF472 and placebo groups for improvement of either primary endpoint at Week 12 will demonstrate efficacy of SNF472: change in Bates-Jensen Wound Assessment Tool-CUA (a quantitative wound assessment tool for evaluating calciphylaxis lesions) or change in pain visual analogue scale score. Additional endpoints will address wound-related QoL, qualitative changes in wounds, wound size, analgesic use and safety. CONCLUSIONS: This randomized, placebo-controlled Phase 3 clinical trial will examine the efficacy and safety of SNF472 in patients who have ulcerated calciphylaxis lesions. Patient recruitment is ongoing.

16.
Sociol Health Illn ; 44(2): 469-487, 2022 02.
Article in English | MEDLINE | ID: mdl-35076086

ABSTRACT

Failures in fundamental care (e.g. nutrition or pain-relief) for hospitalised patients can have serious consequences, including avoidable deaths. Policy rhetoric of 'shared decision-making' fails to consider how structural constraints and power dynamics limit patient agency in nursing staff-patient interactions. Goffman's concepts of face work, the presentation of self and the Total Institution shaped our analysis of interview and focus group data from hospital patients. Patients avoided threatening 'good' patient and staff face by only requesting missed care when staff face was convincing as 'caring' and 'available' ('engaged'). Patients did not request care from 'distracted' staff ('caring' but not 'available'), whilst patient requests were ignored in Total Institution-like 'dismissive' interactions. This meant patients experienced missed care with both 'distracted' and 'dismissive' staff. Patients with higher support needs were less able to carry out their own missed care to protect staff face, so experienced more serious care omissions. These findings show that many elements of the Total Institution survive in modern healthcare settings despite attempts to support individualised care. Unless nursing staff can maintain face as 'engaged' (despite organisational constraints that can reduce their capacity to do so) patient participation in care decisions will remain at the level of rhetoric.


Subject(s)
Inpatients , Patient Participation , Humans
17.
Int Wound J ; 19(4): 811-825, 2022 May.
Article in English | MEDLINE | ID: mdl-34469077

ABSTRACT

This study assesses the impact of a processed microvascular tissue (PMVT) allograft on wound closure and healing in a prospective, single-blinded, multi-centre, randomised controlled clinical trial of 100 subjects with Wagner Grade 1 and 2 chronic neuropathic diabetic foot ulcerations. In addition to standard wound care, including standardised offloading, the treatment arm received PMVT while the control arm received a collagen alginate dressing. The primary endpoint was complete wound closure at 12 weeks. Secondary endpoints assessed on all subjects were percent wound area reduction, time to healing, and local neuropathy. Novel exploratory sub-studies were conducted for wound area perfusion and changes in regional neuropathy. Weekly application of PMVT resulted in increased complete wound closure at 12 weeks (74% vs 38%; P = .0003), greater percent wound area reduction from weeks four through 12 (76% vs 24%; P = .009), decreased time to healing (54 days vs 64 days; P = .009), and improved local neuropathy (118% vs 11%; P = .028) compared with the control arm. Enhanced perfusion and improved regional neuropathy were demonstrated in the sub-studies. In conclusion, this study demonstrated increased complete healing with PMVT and supports its use in treating non-healing DFUs. The observed benefit of PMVT on the exploratory regional neuropathy and perfusion endpoints warrants further study.


Subject(s)
Diabetes Mellitus , Diabetic Foot , Allografts , Bandages , Diabetic Foot/surgery , Humans , Prospective Studies , Treatment Outcome , Wound Healing
18.
Adv Wound Care (New Rochelle) ; 11(12): 639-649, 2022 12.
Article in English | MEDLINE | ID: mdl-34714159

ABSTRACT

Objectives: Bacteria frequently impede wound healing and cause infection. Clinicians rely on clinical signs and symptoms (CSS) to assess for bacteria at the point of care, and inform prescription of antibiotics and other antimicrobials. Yet, robust evidence suggests that CSS has poor sensitivity for detection of problematic bacterial burden and infection, hindering antimicrobial stewardship efforts. This study evaluated CSS-based antimicrobial prescribing practices across 14 wound care centers. Approach: Data were analyzed from the fluorescence assessment and guidance (FLAAG) trial, a study of 350 chronic wounds across 20 clinicians. Clinicians reviewed patient history and assessed for CSS using the International Wound Infection Institute infection checklist. Wounds with >3 criteria or any overwhelming symptom were considered CSS+. Bacterial levels were confirmed with quantitative tissue culture of wound biopsies. Results: Antimicrobials (including dressings, topicals, and systemic antibiotics) were prescribed at a similar rate for wounds identified as CSS+ (75.0%) and CSS- (72.8%, p = 0.76). Antimicrobial dressings, the most frequently prescribed antimicrobial, were prescribed at a similar rate for CSS+ (83.3%) and CSS- (89.5%, p = 0.27) wounds. In 33.3% of patients prescribed systemic antibiotics, no CSS were present. Prescribing patterns did not correlate with bacterial load. Innovation: This study is the first to evaluate antimicrobial prescribing trends in a large, multisite cohort of chronic wound patients. Conclusions: Reliance on CSS to diagnose clinically significant bacterial burden in chronic wounds leads to the haphazard use of antimicrobials. Improved methods of identifying bacterial burden and infection are needed to enhance antimicrobial stewardship efforts in wound care. Clinicaltrials.gov ID. NCT03540004.


Subject(s)
Anti-Infective Agents , Antimicrobial Stewardship , Wound Infection , Anti-Bacterial Agents/therapeutic use , Anti-Infective Agents/therapeutic use , Humans , Wound Healing , Wound Infection/drug therapy
20.
Mol Pharm ; 18(8): 3171-3180, 2021 08 02.
Article in English | MEDLINE | ID: mdl-34279974

ABSTRACT

Current treatment of chronic wounds has been critically limited by various factors, including bacterial infection, biofilm formation, impaired angiogenesis, and prolonged inflammation. Addressing these challenges, we developed a multifunctional wound dressing-based three-pronged approach for accelerating wound healing. The multifunctional wound dressing, composed of nanofibers, functional nanoparticles, natural biopolymers, and selected protein and peptide, can target multiple endogenous repair mechanisms and represents a promising alternative to current wound healing products.


Subject(s)
Annexin A1/administration & dosage , Anti-Inflammatory Agents/administration & dosage , Bandages , Diabetes Mellitus, Experimental/complications , Follistatin-Related Proteins/administration & dosage , Peptides/administration & dosage , Staphylococcal Infections/complications , Staphylococcal Infections/drug therapy , Staphylococcus aureus/drug effects , Surgical Wound/complications , Surgical Wound/drug therapy , Wound Healing/drug effects , Wound Infection/complications , Wound Infection/drug therapy , 3T3 Cells , Animals , Biocompatible Materials/administration & dosage , Biopolymers/chemistry , Cell Survival/drug effects , Diabetes Mellitus, Experimental/chemically induced , HaCaT Cells , Humans , Magnetic Iron Oxide Nanoparticles/chemistry , Male , Materials Testing/methods , Mice , Nanofibers/chemistry , Rats , Rats, Wistar , Staphylococcal Infections/microbiology , Treatment Outcome , Wound Infection/microbiology
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