Clinical and cost efficacy of advanced wound care matrices in the treatment of venous leg ulcers: a systematic review

2021 ◽  
Vol 30 (7) ◽  
pp. 553-561
Author(s):  
Sameer Massand ◽  
Joseph A Lewcun ◽  
Charles A LaRosa

Background: Venous leg ulcers (VLUs) are hard-to-heal, recurrent and challenging to treat. Advanced wound care matrices (AWCMs) have been developed to supplement conventional therapies. These costly AWCMs warrant careful comparison as healthcare expenditures are subjected to increasing scrutiny. Aim: This study was designed to compare AWCMs in their ability to heal VLUs and their cost efficacy through a systematic review of randomised controlled trials (RCTs). Method: An organised search of Medline, Cochrane Library, Central and CINAHL databases identified RCTs that compared AWCMs to standard compression therapy in the healing of VLUs. Bias was assessed using the Effective Public Health Practice Project (EPHPP) Quality Assessment Tool for Quantitative Studies. Eight studies analysing bilayered skin substitute (BSS) (Apligraf), dehydrated human amnion/chorion membrane (dHACM) (Epifix), human fibroblast-derived dermal substitute (HFDDS) (Dermagraft), extracellular wound matrix (ECM) (Oasis), advanced matrix (AM) (Talymed) and matrix wound dressing (MWD) (Promogran) met the inclusion criteria. Results: Four studies reported significant improvement over standard therapy: BSS, dHACM, ECM and AM. Incremental cost per additional successful treatment was determined for each trial, ranging from $2593 (MWD) to $210,800 (HFDDS). Conclusion: Our consolidated analysis of eight major RCTs of AWCMs in the treatment of VLUs revealed a great variation in clinical and cost efficacy among these products. The included trials were inconsistent in methodology, and these limitations should be noted, but, in the absence of RCTs to compare these products, our systematic review may serve as a guide for practitioners who seek to optimise wound healing while considering cost efficacy.

BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032091
Author(s):  
Thalita Paranhos ◽  
Caroline S B Paiva ◽  
Fernanda C I Cardoso ◽  
Priscila P Apolinário ◽  
Flavia Figueiredo Azevedo ◽  
...  

IntroductionChronic venous insufficiency (CVI) is an anomaly of the normal functioning of the venous system caused by valvular incompetence with or without the obstruction of venous flow. This condition can affect either or both of the superficial and the deep venous systems. Venous dysfunction can even result in congenital or acquired disorders, and its complications include venous leg ulcers (VLUs). The objective of this systematic review is to determine the effectiveness of Unna boot in the treatment of wound healing of VLU by assessing the quality of the available evidence.Methods and analysisA literature search in PubMed, CINAHL, Scopus, Web of Science, Cochrane Library, BVS/BIREME, Embase, ProQuest, BDTD, Thesis and Dissertation Catalog, Sao Paulo Research Foundation/Thesis and dissertation, OPEN THESIS, A service of the US National Institute of Health, Center for Reviews and Dissemination-University of New York and SciElo published in the last 10 years, the period from January 1999 to March 2019. The review will include primary studies (original), and Controlled Trials or Observational studies (cross-sectional, case–control or longitudinal studies) with VLU. The exclusion will include leg ulceration due to different causes, such as pressure, arterial, diabetic or mixed-aetiology leg ulcers. Data synthesis will be performed using a narrative summary and quantitative analysis.Ethics and disseminationThis systematic review does not require approval by the ethics committee, as individual patient data will not be collected. Dissemination of findings will be through publications in peer-reviewed journals and/or via conference presentations.PROSPERO registration numberCRD42019127947


2020 ◽  
Vol 29 (2) ◽  
pp. 79-91 ◽  
Author(s):  
Emer Shanley ◽  
Zena Moore ◽  
Declan Patton ◽  
Tom O’Connor ◽  
Linda Nugent ◽  
...  

Objective: To investigate the impact of patient education interventions on preventing the recurrence of venous leg ulcers (VLU). Method: A systematic review was undertaken using the following databases: Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library); Ovid; Ovid (In-process and Other Non-Indexed Citations); Ovid Embase and EBSCO CINAHL. Trial registries and reference lists of relevant publications for published and ongoing trials were also searched. There were no language or publication date restrictions. Randomised controlled trials (RCTs) and cluster RCTs of patient educational interventions for preventing VLU recurrence were included. Review authors working independently assessed trials for their appropriateness for inclusion and for their risk of bias, using pre-determined inclusion and quality criteria. Results: A total of four studies met the inclusion criteria (274 participants). Each trial explored different interventions as follows: the Lively legs programme; education delivered via a video compared with education delivered via a pamphlet; the Leg Ulcer Prevention Programme and the Lindsay Leg Club. Only one study reported the primary outcome of incidence of VLU recurrence. All studies reported at least one of the secondary outcomes: patient behaviours, patient knowledge and patient quality of life (QoL). It is uncertain whether patient education programmes make any difference to VLU recurrence at 18 months (risk ratio [RR]: 0.82; 95% confidence interval: [CI] 0.59 to 1.14) or to patient behaviours (walked at least 10 minutes/five days a week RR: 1.48; 95%CI: 0.99 to 2.21; walked at least 30 minutes/five days a week: RR 1.14; 95%CI: 0.66 to 1.98; performed leg exercises: RR: 1.47; 95%CI: 1.04 to 2.09); to knowledge scores (MD (mean difference) 5.12, 95% CI –1.54 to 11.78); or to QoL (MD: 0.85, 95% CI –0.13 to 1.83), as the certainty of evidence has been assessed as very low. It is also uncertain whether different types of education delivery make any difference to knowledge scores (MD: 12.40; 95%CI: –5.68 to 30.48). Overall, GRADE assessments of the evidence resulted predominantly in judgments of very low certainty. The studies were at high risk of bias and outcome measures were imprecise due to wide CIs and small sample sizes. Conclusion: It is uncertain whether education makes any difference to the prevention of VLU recurrence. Therefore, further well-designed trials, addressing important clinical, QoL and economic outcomes are justified, based on the incidence of the problem and the high costs associated with VLU management.


Author(s):  
Elaine Greene ◽  
Pinar Avsar ◽  
Zena Moore ◽  
Linda Nugent ◽  
Tom O’Connor ◽  
...  

Diagnostics ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. 2206
Author(s):  
Dana Li ◽  
Lea Marie Pehrson ◽  
Carsten Ammitzbøl Lauridsen ◽  
Lea Tøttrup ◽  
Marco Fraccaro ◽  
...  

Our systematic review investigated the additional effect of artificial intelligence-based devices on human observers when diagnosing and/or detecting thoracic pathologies using different diagnostic imaging modalities, such as chest X-ray and CT. Peer-reviewed, original research articles from EMBASE, PubMed, Cochrane library, SCOPUS, and Web of Science were retrieved. Included articles were published within the last 20 years and used a device based on artificial intelligence (AI) technology to detect or diagnose pulmonary findings. The AI-based device had to be used in an observer test where the performance of human observers with and without addition of the device was measured as sensitivity, specificity, accuracy, AUC, or time spent on image reading. A total of 38 studies were included for final assessment. The quality assessment tool for diagnostic accuracy studies (QUADAS-2) was used for bias assessment. The average sensitivity increased from 67.8% to 74.6%; specificity from 82.2% to 85.4%; accuracy from 75.4% to 81.7%; and Area Under the ROC Curve (AUC) from 0.75 to 0.80. Generally, a faster reading time was reported when radiologists were aided by AI-based devices. Our systematic review showed that performance generally improved for the physicians when assisted by AI-based devices compared to unaided interpretation.


Author(s):  
Eduardo Anitua ◽  
Beatriz Anitua ◽  
Mohammad Hamdan Alkhraisat ◽  
Laura Piñas ◽  
Asier Eguia ◽  
...  

Purpose The aim of this work is to assess the clinical outcomes of implants placed after a nasal floor elevation procedure. Methods A systematic review was conducted using four electronic databases; Medline (Pubmed), Cochrane library, DOAJ and SCOPUS, following the PRISMA statement recommendations to answer the PICO question: “In patients undergoing dental implant placement in the maxillary anterior region (P), Do implants placed after nasal floor elevation (I) have a different survival (O) from those implants placed without grafting procedures (C)?. The study was pre-registered in PROSPERO (CRD42021229479). Included articles quality was assessed using the “NIH quality assessment tool”, “The Newcastle-Ottawa scale” and “JBI critical appraisal tools for case reports''. Results Twelve articles were finally selected, including 151 patients and 460 implants. The weighted mean follow-up was 32.2 months, and the weighted survival rate after this period was 97.64% (range 89.2-100%). No statistical differences could be inferred between the treatments performed in one-stage or two-stage, following a lateral approach or a transcrestal approach or using different grafting materials. A great heterogeneity was found in terms of study design and methodological aspects. For this reason, a quantitative analysis followed by meta-analysis was not possible. Conclusion Within the limitations of this study, implants placed after a nasal floor elevation present a good survival and a low range of complications. In absence of randomized studies, the level of evidence was low, attending the GRADE system and based on the study quality level, the strength of evidence attending the SORT taxonomy was B.


2018 ◽  
Vol 15 (3) ◽  
pp. 441-453 ◽  
Author(s):  
Daisy Smith ◽  
Rebecca Lane ◽  
Rosemary McGinnes ◽  
Jane O'Brien ◽  
Renea Johnston ◽  
...  

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e039898
Author(s):  
Weijing Fan ◽  
Baozhong Yang ◽  
Xiaoming Hu ◽  
Xiao Yang ◽  
Chenyan Shi ◽  
...  

IntroductionLeg ulcers (LUs) not only seriously affect life and work of patients, but also bring huge economic burden to the society. As a potential underused biological debridement, larval therapy provides help for the treatment of LUs. The purpose of our research is to assess whether patients with LUs can benefit from larval therapy.Methods and analysisThe following electronic databases will be searched: PubMed, EMBASE, Web of Science, the Cochrane Library, China National Knowledge Infrastructure Database, Wanfang Database and Chinese Biological Medicine. Randomised controlled trials are eligible for inclusion. There will be no restrictions with respect to language and search date is up to June 2020. Primary outcomes investigated are complete healing rate after treatment, time to ulcer healing, reduction of wound surface area and adverse events. Risk ratios will be used for categorical data; weighted mean difference will be used for measurement data. Subgroup analysis and sensitivity analysis will be considered if heterogeneity exists. The results of data synthesis will be performed by narrative summary and quantitative analysis.Ethics and disseminationThis systematic review does not require the approval of the ethics committee because individual data on patients are not collected. The results of the study will be disseminated in peer-reviewed journals.PROSPERO registration numberCRD42020176953.


1998 ◽  
Vol 3 (4) ◽  
pp. 301-313 ◽  
Author(s):  
Simon J Palfreyman ◽  
Rona Lochiel ◽  
Jonathan A Michaels

2020 ◽  
Vol 29 (3) ◽  
pp. 169-175
Author(s):  
Valentina Dini ◽  
Agata Janowska ◽  
Teresa Oranges ◽  
Andrea De Pascalis ◽  
Michela Iannone ◽  
...  

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