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Wound Repair and Regeneration :... May 2021The wound microbiome may play an important role in the wound healing process. We conducted the first systematic prognosis review investigating whether aspects of the... (Review)
Review
The wound microbiome may play an important role in the wound healing process. We conducted the first systematic prognosis review investigating whether aspects of the wound microbiome are independent prognostic factors for the healing of complex wounds. We searched Medline, Embase, CINAHL and the Cochrane Library to February 2019. We included longitudinal studies which assessed the independent association of aspects of wound microbiome with healing of complex wounds while controlling for confounding factors. Two reviewers extracted data and assessed risk of bias and certainty of evidence using the GRADE approach. We synthesised studies narratively due to the clinical and methodological heterogeneity of included studies and sparse data. We identified 28 cohorts from 21 studies with a total of 38,604 participants, including people with diabetes and foot ulcers, open surgical wounds, venous leg ulcers and pressure ulcers. Risk of bias varied from low (2 cohorts) to high (17 cohorts); the great majority of participants were in cohorts at high risk of bias. Most evidence related to the association of baseline clinical wound infection with healing. Clinical infection at baseline may be associated with less likelihood of wound healing in foot ulcers in diabetes (HR from cohort with moderate risk of bias 0.53, 95% CI 0.33 to 0.83) or slower healing in open surgical wounds (HR 0.65, 95% CI 0.51 to 0.83); evidence in other wounds is more limited. Most other associations assessed showed no clear relationship with wound healing; evidence was limited and often sparse; and we documented gaps in the evidence. There is low certainty evidence that a diagnosis of wound infection may be prognostic of poorer healing in foot ulcers in diabetes, and some moderate certainty evidence for this in open surgical wounds. Low certainty evidence means that more research could change these findings.
Topics: Bacteria; Humans; Prognosis; Surgical Wound; Varicose Ulcer; Wound Healing
PubMed: 33591630
DOI: 10.1111/wrr.12898 -
Journal of Vascular Surgery. Venous and... Jul 2023We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
We assessed the mid-term efficacy and safety of thermal and nonthermal endovenous ablation for the treatment of lower limb superficial venous insufficiency.
METHODS
We performed a systematic review in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) statement and a Bayesian network meta-analysis. The primary end points were great saphenous vein (GSV) closure and venous clinical severity score (VCSS) improvement. A meta-regression using GSV diameter as a covariate was undertaken for the two primary end points.
RESULTS
We included 14 studies and 4177 patients, with a mean follow-up of 25.7 months. Radiofrequency ablation (RFA; odds ratio [OR], 3.99; 95% confidence interval [CI], 1.82-10.53), cyanoacrylate ablation (CAC; OR, 3.09; 95% CI, 1.35-8.37), and endovenous laser ablation (EVLA; OR, 2.72; 95% CI, 1.23-7.38) displayed increased odds for GSV closure compared with mechanochemical ablation (MOCA). MOCA inferiority compared with RFA (mean difference [MD], 0.96; 95% CI, 0.71-1.20), EVLA (MD, 0.94; 95% CI, 0.61-1.24), and CAC (MD, 0.89; 95% CI, 0.65-1.15) was also depicted regarding VCSS improvement. EVLA resulted in an increased risk of postoperative paresthesia compared with MOCA (risk ratio [RR], 9.61; 95% CI, 2.32-62.29), CAC (RR, 7.90; 95% CI, 2.44-38.16), and RFA (RR, 6.96; 95% CI, 2.31-28.04). Although the overall analysis identified nonstatistically significant differences for Aberdeen varicose vein questionnaire score improvement, thrombophlebitis, ecchymosis, and pain, further investigation revealed an increase pain profile for EVLA at 1470 nm compared with RFA (MD, 3.22; 95% CI, 0.93-5.47) and CAC (MD, 3.04; 95% CI, 1.05-4.97). A sensitivity analysis displayed a persistent underperformance of MOCA compared with RFA (OR, 4.33; 95% CI, 1.15-55.54) for GSV closure and both RFA (MD, 0.99; 95% CI, 0.22-1.77) and CAC (MD, 0.84; 95% CI, 0.08-1.65) regarding VCCS improvement. Although no regression model reached statistical significance, the GSV closure regression model revealed a trend for considerably decreased efficacy for both CAC and MOCA with larger GSV diameters compared with RFA and EVLA.
CONCLUSIONS
Although our analysis has produced skepticism regarding the efficacy of MOCA in the mid-term period for VCSS improvement and GSV closure rates, CAC showed equivalent results compared with both RFA and EVLA. Additionally, CAC displayed a decreased risk of postprocedural paresthesia and pigmentation and induration compared with EVLA. Also, both RFA and CAC had an improved pain profile compared with EVLA 1470 nm. The potential underperformance of nonthermal, nontumescent ablation modalities in ablating large GSVs necessitates further research.
Topics: Humans; Network Meta-Analysis; Bayes Theorem; Paresthesia; Treatment Outcome; Venous Insufficiency; Saphenous Vein; Pain
PubMed: 37030442
DOI: 10.1016/j.jvsv.2023.03.011 -
Phlebology Aug 2022This study examines the influence of Earth's gravity field on the prevalence of varicose veins in geophysical area.
AIM
This study examines the influence of Earth's gravity field on the prevalence of varicose veins in geophysical area.
MATERIAL AND METHODS
We performed a systematic review (OVID and Google Scholar) of studies focusing on prevalence of varicose veins to determine the influence of Earth's gravity field-GRACE GGM05S gravity model-on the disease prevalence. PROSPERO: CRD42021279513.
RESULTS
81 studies met inclusion and quality criteria. Areas with stronger gravity have significantly higher prevalence of varicose veins with adjustment for age, gender and body mass index (BMI) (-values < 0.02). Adjusted for age, prevalence of varicose veins in areas with gravity field +20 mGal and more is 1.37 time higher than in areas with gravity field less than +20 mGal, -value 0.005 (95% CI: -12.5 to -2.4): mean disease prevalence for gravity field +20 mGal and more-27.5% (mean age, 40.1 years; mean gravity field, +27.1 mGal; 63.9% females, 37 studies, 123,164 participants) vs mean disease prevalence for gravity field less than +20 mGal - 20.1% (mean age, 42.2 years; mean gravity field, +5.7 mGal; 56.8% females, 44 studies, 205,925 participants). Older age is the main risk factor for varicose veins (-values < 0.005). Female gender and high BMI are insignificantly associated with high prevalence of varicose veins (-values > 0.4 for gender, -values > 0.2 for BMI).
CONCLUSION
Stronger gravity field is significantly associated with higher prevalence of varicose veins-risk factor. The potential mechanism of this phenomenon is that high gravity field alters systemic venous return, pooling blood and fluid in the peripheral, gravity-dependent regions of the body in upright humans constantly living in the defined geophysical area.
Topics: Adult; Body Mass Index; Chronic Disease; Female; Humans; Male; Prevalence; Risk Factors; Varicose Veins
PubMed: 35471106
DOI: 10.1177/02683555221090054 -
Vascular Jun 2015The purpose of this systematic review and meta-analysis is to synthesise the available evidence of randomised controlled trials comparing endovenous laser therapy to... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
The purpose of this systematic review and meta-analysis is to synthesise the available evidence of randomised controlled trials comparing endovenous laser therapy to traditional open surgery, high ligation and stripping, for the treatment of great saphenous vein varicose veins in terms of clinical effectiveness, patient satisfaction and peri-operative complications.
METHODS
MEDLINE, CINAHL, EMBASE and the Cochrane library were searched to identify eligible studies. All randomised controlled trials comparing endovenous laser therapy to high ligation and stripping that used ultrasound examination as an outcome measure and had follow up of one year or more were included. The Cochrane Collaboration's tool for assessing risk of bias was also used to assess the methodological quality of the included studies. Pooled risk ratios with 95% confidence intervals were used as the measure of effect for each dichotomous outcome.
FINDINGS
Nine eligible publications relating to six randomised controlled trials were identified. The total enrolment of the studies was 1289 limbs. The clinical efficacy of endovenous laser therapy is comparable to that of surgery in the relatively short follow up period described in the studies. Meta-analysis revealed a trend towards a higher risk of ultrasound recurrence after endovenous laser therapy at 12 months. Quality of life questionnaires reveal similar outcomes for endovenous laser therapy and surgery. There is low quality evidence to suggest surgery is associated with more pain, sensory complications and infection.
CONCLUSION
Endovenous laser therapy is a safe alternative to traditional open surgery. There is some weak evidence to suggest that endovenous laser therapy has a higher risk of ultrasound-detected recurrence at 12 months following treatment compared to open surgery. However, it may be associated with less sensory complications, pigmentation and infection.
Topics: Adolescent; Adult; Aged; Femoral Vein; Humans; Laser Therapy; Middle Aged; Quality of Life; Saphenous Vein; Surveys and Questionnaires; Varicose Veins; Young Adult
PubMed: 25026892
DOI: 10.1177/1708538114542633 -
Journal of Vascular Surgery. Venous and... Apr 2015We conducted a systematic review of the literature about quality-of-life (QOL) scales in chronic venous disorders (CVDs) comprising leg ulcers to identify the respective... (Review)
Review
OBJECTIVE
We conducted a systematic review of the literature about quality-of-life (QOL) scales in chronic venous disorders (CVDs) comprising leg ulcers to identify the respective advantages and deficits of existing tools.
METHODS
A research protocol was built following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and the PICO (population, intervention, comparator, and outcome) criteria. The following databases were screened: MEDLINE, SCOPUS, EMBASE, CINHAL, and Cochrane. Psychometric and linguistic validation studies in English were included, as were clinical trials that have used QOL scales in CVDs. The data search was up to date as of October 31, 2013.
RESULTS
Inclusion criteria were met in 103 of the 511 recorded references, in which 10 scales were identified: two for the full spectrum of CVDs, three for patients with CVDs without leg ulceration, four for leg ulcers, and one exclusively for patients with varicose veins. Among them, the ChronIc Venous Insufficiency Questionnaire (CIVIQ), Aberdeen Varicose Vein Questionnaire (AVVQ), and VEnous INsufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) scales were the most highly used according to the literature, and CIVIQ and VEINES-QOL were the most extensively validated scales and had the longest iterative validation process. A total of 31 psychometric and linguistic validations of the 10 QOL scales and 66 clinical trials that have used these scales were identified. The validation studies were based on acceptability, content validity, construct validity, reliability, and responsiveness. The clinical trials were composed of 25 randomized controlled trials and 41 observational studies. Only the randomized controlled trials are considered in the present article.
CONCLUSIONS
This systematic review confirmed that CVDs have an important effect on QOL. The majority of the studies addressed the application rather than the validation of the 10 identified scales. Two scales, CIVIQ and VEINES-QOL, emerged as being thoroughly validated instruments, although factorial stability was not demonstrated for the VEINES-QOL. Our findings confirm a paucity of validation studies.
Topics: Chronic Disease; Humans; Leg; Psychometrics; Quality of Life; Randomized Controlled Trials as Topic; Reproducibility of Results; Surveys and Questionnaires; Varicose Ulcer; Varicose Veins; Venous Insufficiency
PubMed: 26993844
DOI: 10.1016/j.jvsv.2014.08.005 -
The British Journal of Surgery Oct 2017Varicose veins can affect quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient about the impact of the disease without... (Review)
Review
BACKGROUND
Varicose veins can affect quality of life. Patient-reported outcome measures (PROMs) provide a direct report from the patient about the impact of the disease without interpretation from clinicians or anyone else. The aim of this study was to examine the quality of the psychometric evidence for PROMs used in patients with varicose veins.
METHODS
A systematic review was undertaken to identify studies that reported the psychometric properties of generic and disease-specific PROMs in patients with varicose veins. Literature searches were conducted in databases including MEDLINE, up to July 2016. The psychometric criteria used to assess these studies were adapted from published recommendations in accordance with US Food and Drug Administration guidance.
RESULTS
Nine studies were included which reported on aspects of the development and/or validation of one generic (36-Item Short Form Health Survey, SF-36®) and three disease-specific (Aberdeen Varicose Vein Questionnaire, AVVQ; Varicose Veins Symptoms Questionnaire, VVSymQ®; Specific Quality-of-life and Outcome Response - Venous, SQOR-V) PROMs. The evidence from included studies provided data to support the construct validity, test-retest reliability and responsiveness of the AVVQ. However, its content validity, including weighting of the AVVQ questions, was biased and based on the opinion of clinicians, and the instrument had poor acceptability. VVSymQ® displayed good responsiveness and acceptability rates. SF-36® was considered to have satisfactory responsiveness and internal consistency.
CONCLUSION
There is a scarcity of psychometric evidence for PROMs used in patients with varicose veins. These data suggest that AVVQ and SF-36® are the most rigorously evaluated PROMs in patients with varicose veins.
Topics: Humans; Patient Reported Outcome Measures; Psychometrics; Surveys and Questionnaires; Varicose Veins
PubMed: 28771700
DOI: 10.1002/bjs.10639 -
The Cochrane Database of Systematic... Jun 2016Venous leg ulcers are common, chronic wounds caused by venous diseases, with a high recurrence rate and heavy disease burden. Compression therapy (bandages or stockings)... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Venous leg ulcers are common, chronic wounds caused by venous diseases, with a high recurrence rate and heavy disease burden. Compression therapy (bandages or stockings) is the first choice treatment for venous leg ulcers. However, when ulcers remain unhealed, medication can also be used with or without compression therapy. Sulodexide, a highly purified glycosaminoglycan (a naturally occurring molecule) has antithrombotic and profibrinolytic properties (it reduces the formation of blood clots) as well as anti-inflammatory effects. Sulodexide has been studied as a potential treatment for venous leg ulcers.
OBJECTIVES
To assess the efficacy and safety of sulodexide for treating venous leg ulcers.
SEARCH METHODS
In July 2015 we searched: The Cochrane Wounds Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE; EBSCO CINAHL; Chinese Biomedical Literature Database (CBM); China National Knowledge Infrastructure Database (CNKI); Wan Fang and VIP. We also searched clinical trials registries to identify ongoing studies, as well as references listed in relevant publications. There were no restrictions based on date of publication, language or study setting.
SELECTION CRITERIA
Randomised controlled trials (RCTs) involving people with a diagnosis of venous leg ulcers which compared sulodexide with placebo or any other drug therapy (such as pentoxifylline, flavonoids, aspirin), with or without compression therapy.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. The authors independently selected studies, extracted data and assessed risk of bias. We pooled data to present the risk ratio (RR) with 95% confidence interval (CI), or presented a narrative summary. We assessed overall evidence quality according to the GRADE approach.
MAIN RESULTS
We included four RCTs with a total of 463 participants (aged 42 years to 93 years); one report was only available as a published abstract.Meta-analysis of three RCTs suggests an increase in the proportion of ulcers completely healed with sulodexide as an adjuvant to local treatment (including wound care and compression therapy) compared with local treatment alone (rate of complete healing with sulodexide 49.4% compared with 29.8% with local treatment alone; RR 1.66; 95% CI 1.30 to 2.12). This evidence for sulodexide increasing the rate of complete healing is low quality due to risk of bias. It is unclear whether sulodexide is associated with any increase in adverse events (4.4% with sulodexide versus 3.1% with no sulodexide; RR 1.44; 95% CI 0.48 to 4.34). The evidence for adverse events is very low quality, downgraded twice for risk of bias and once for imprecision.
AUTHORS' CONCLUSIONS
Sulodexide may increase the healing of venous ulcers, when used alongside local wound care, however the evidence is only low quality and the conclusion is likely to be affected by new research. It is not clear whether sulodexide is associated with adverse effects. The standard dosage, route and frequency of sulodexide reported in the trials was unclear. Further rigorous, adequately powered RCTs examining the effects of sulodexide on healing, ulcer recurrence, quality of life and costs are necessary.
Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Fibrinolytic Agents; Glycosaminoglycans; Humans; Middle Aged; Randomized Controlled Trials as Topic; Varicose Ulcer
PubMed: 27251175
DOI: 10.1002/14651858.CD010694.pub2 -
Sao Paulo Medical Journal = Revista... 2018Varicose veins affect nearly 30% of the world's population. This condition is a social problem and needs interventions to improve quality of life and reduce risks....
BACKGROUND
Varicose veins affect nearly 30% of the world's population. This condition is a social problem and needs interventions to improve quality of life and reduce risks. Recently, new and less invasive methods for varicose vein treatment have emerged. There is a need to define the best treatment options and to reduce the risks and costs. Since there are cosmetic implications, treatments for which effectiveness remains unproven present risks to consumers and higher costs for stakeholders. These risks and costs justify conducting an overview of systematic reviews to summarize the evidence.
DESIGN AND SETTING
Overview of systematic reviews within the Discipline of Evidence-Based Health, at Universidade Federal de São Paulo (UNIFESP).
METHODS
Systematic reviews on clinical or surgical treatments for varicose veins were included, with no restrictions on language or publication date.
RESULTS
51 reviews fulfilled the inclusion criteria. Outcomes and comparators were described, and a narrative review was conducted. Overall, there was no evidence that compression stockings should be recommended for patients as the initial treatment or after surgical interventions. There was low to moderate evidence that minimally invasive therapies (endovenous laser therapy, radiofrequency ablation or foam sclerotherapy) are as safe and effective as conventional surgery (ligation and stripping). Among these systematic reviews, only 18 were judged to present high quality.
CONCLUSIONS
There was evidence of low to moderate quality that minimally invasive treatments, including foam sclerotherapy, laser and radiofrequency therapy are comparable to conventional surgery, regarding effectiveness and safety for treatment of varicose veins.
Topics: Evidence-Based Medicine; Humans; Laser Therapy; Saphenous Vein; Sclerotherapy; Varicose Veins; Vascular Surgical Procedures
PubMed: 30020324
DOI: 10.1590/1516-3180.2018.0003240418 -
Journal of Vascular Surgery. Venous and... Jan 2022In the present study, we reviewed and analyzed the currently available data on the Flebogrif device (Balton, Warsaw, Poland) to define its role in the global varicose... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
In the present study, we reviewed and analyzed the currently available data on the Flebogrif device (Balton, Warsaw, Poland) to define its role in the global varicose vein treatment devices market.
METHODS
A systematic literature search was performed in MEDLINE, Embase, and the Cochrane Library. Studies were eligible if they had included patients treated using the Flebogrif for saphenous vein incompetence, had been reported in English, and had the full text available. The methodologic quality of the studies was assessed using the methodologic index for nonrandomized studies (MINORS) score. A random effects model was used to estimate the primary outcome of anatomic success, defined as the occlusion rate of the treated vein. The estimates are reported with the 95% confidence intervals (CIs). The secondary outcomes were clinical success, complication rate, pain during and after the procedure, and time to return to work.
RESULTS
Five articles met the inclusion criteria, reporting 348 procedures in 392 patients. Four studies reported the 3-month anatomic success, and three studies reported the 12-month anatomic success. The pooled 3-month anatomic success rate was 95.6% (95% CI, 93.2%-98.0%). The 12-month anatomic success rate was 93.2% (95% CI, 90.3%-96.1%). The only major complication reported within 3 months was deep vein thrombosis, which developed in 0.3% of the patients. The minor complications of thrombophlebitis and hyperpigmentation had occurred in 13.3% to 14.5% and 3.3% to 10.0% of patients, respectively, within 3 months. The methodologic quality of the included studies was moderate.
CONCLUSIONS
Mechanochemical ablation using the Flebogrif device is a safe and well-tolerated procedure for the treatment of saphenous vein insufficiency. However, well-designed studies of sufficient sample size and follow-up are required to compare the effectiveness with other endovenous treatment modalities and define the definitive role of the Flebogrif device.
Topics: Ablation Techniques; Catheters; Combined Modality Therapy; Endovascular Procedures; Humans; Varicose Veins
PubMed: 34091106
DOI: 10.1016/j.jvsv.2021.05.010 -
Journal of Vascular Surgery. Venous and... Jul 2022Because of the fear of obliterating the collateral outflow path and thus worsening venous hypertension, many physicians believe that deep venous obstruction (DVO) is a... (Review)
Review
BACKGROUND
Because of the fear of obliterating the collateral outflow path and thus worsening venous hypertension, many physicians believe that deep venous obstruction (DVO) is a contraindication for the treatment of superficial venous reflux (SVR). In the present review, we have described the available clinical data for this important group of patients.
METHODS
A literature search was performed of PubMed, Web of Science, and Google Scholar to identify clinical research studies reported between 1991 and 2021 that had evaluated the concomitant management of SVR and DVO. Studies were excluded if they had included fewer than five patients, had not specified the interventions used to treat SVR, or had no follow-up data available. All the studies included were observational, and their quality was assessed using the Newcastle-Ottawa scale.
RESULTS
Ten retrospective cohort studies were included, with a total of 2476 limbs in 2428 patients, with concurrent SVR and DVO or a known history of deep vein thrombosis treated in 944 limbs. Of the 10 studies, 8 were comparative. The level of DVO was suprainguinal, when specified, in most cases. The mean age range was 42 to 65 years, 1432 patients (59%) were women, and advanced chronic venous disease (ie, CEAP [clinical, etiologic, anatomic, pathophysiologic] class 4-6) was present in 614 limbs (70%), with two studies reporting uniquely on C6 patients. Of the 944 limbs treated for concomitant SVR and DVO, a combination of saphenous vein ablative procedures and deep venous stenting was performed in 483 limbs (51.2%), saphenous vein ablative procedures alone in 293 limbs (31%), and deep venous stenting alone in 168 (17.8%). Of the five studies comparing the different treatment strategies to treat concurrent SVR and DVO, four reported better outcomes after a combination of deep venous stenting and saphenous vein ablation compared with ablation alone. Studies comparing the outcomes of saphenous ablation for patients with reflux alone vs patients with concurrent reflux and DVO did not find any significant differences in clinical improvement and postoperative complication rates.
CONCLUSIONS
The current evidence is weak owing to the limited number of studies and small sample size but suggests that ablation of SVR is safe for patients with concurrent DVO. Patients with advanced venous disease and iliac vein obstruction had better results when SVR ablation was combined with treatment of iliac vein obstruction. Additional contemporary studies are needed to confirm the safety and specifically investigate the efficacy of SVR ablation in relieving the symptoms of patients with concurrent infrainguinal obstruction.
Topics: Adult; Aged; Chronic Disease; Female; Femoral Vein; Humans; Male; Middle Aged; Retrospective Studies; Saphenous Vein; Treatment Outcome; Vascular Diseases; Venous Insufficiency
PubMed: 35066218
DOI: 10.1016/j.jvsv.2021.12.087