Comparative effectiveness of surgical interventions aimed at treating underlying venous pathology in patients with chronic venous ulcer

Malas, Mahmoud B.; Qazi, Umair; Lazarus, Gerald S.; Valle, M. Fran; Wilson, Lisa M; Haberl, Elisabeth B; Bass, Eric B.; Zenilman, Jonathan M.

doi:10.1016/j.jvsv.2013.10.002

Cited by 12 publications

(19 citation statements)

References 22 publications

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“…Cochrane reviews including wound reviews are published and maintained in the Cochrane Library. The majority of efficacy trials in wound healing in the USA, are performed for registration (FDA approval) and use strict FDA mandated endpoints …”

Section: Present Evidence Based Standardsmentioning

confidence: 99%

“…These guidance documents tend to define VLU either based on clinical presentation or based on the confirmation of anatomic/structural venous abnormalities. Most clinical trials that have been published on advanced wound care for the treatment of VLU have based the diagnosis of VLU on clinical findings and location . However, as early as 2006 the Wound Healing Society defined VLU as ulcers of the lower extremity that may be caused by elevation of ambulatory venous pressure, referred to as “venous hypertension,” which they defined as a measurable structural alteration in the venous system of the lower extremity .…”

Section: Specific Considerations In Venous Ulcer Researchmentioning

confidence: 99%

“…As has been conclusively demonstrated the quality of clinical research on VLUs often do not meet current evidence based standards. In addition to a controversial definition of VLU there are multiple specific shortcomings . Wound measurements are imprecise.…”

Section: Specific Deficiencies In Venous Ulcer Researchmentioning

confidence: 99%

“…A number of Clinical Effectiveness Reviews (CER) were recently published that questioned the quality of clinical research articles informing therapy for venous leg ulcers (VLUs) . For example, an Agency for Health Care Research and Quality (AHRQ) study reviewed 10,066 citations from the world's venous ulcer literature and found that only 60 papers could be analyzed; that means only 0.6% of the articles met 2012 evidence standards.…”

mentioning

confidence: 99%

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Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research

Lazarus

Kirsner

Zenilman

et al. 2016

Wound Repair Regeneration

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The present status of clinical leg ulcer healing research was reviewed by 25 experts over 2 days on September 28 and 29, 2015. Multiple clinical effectiveness reviews were presented suggesting that published clinical wound healing research often does not meet present (2015) evidence based standards. Specific areas requiring remediation were highlighted and approaches to overcoming existing challenges were proposed. Participants using anonymous voting technology developed an action plan to resolve perceived deficiencies. Statements were accepted if 75% of participants agreed. Older patients with a high frequency of comorbid conditions posed particular difficulties in designing clinical research protocols and better diagnostic categorization is necessary A standardized model template for collecting information about diagnosis and evaluation of the effect of interventions on healing of all types of leg ulcers was considered a high priority. Such a model template could be modified depending on the specific etiology of the leg ulcers. Generally agreed on quantifiable standards to establish degree of morbidity was considered a high priority. There was universal agreement that sources of funding and conflicts of interest needed to be disclosed in presentations and all publications. All clinical research studies should be registered with appropriate authorities. There was substantial enthusiasm for a clinical research network with quality standards for membership and an advisory research core available to investigators. Such a network should be funded and actively managed to insure long-term viability. The governance of such an entity needs to be established by the wound care community. The present trend to integrate patients into the clinical research process was endorsed and there was enthusiasm to develop patient advocacy for wound healing research.

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Section: Present Evidence Based Standardsmentioning

confidence: 99%

Section: Specific Considerations In Venous Ulcer Researchmentioning

confidence: 99%

Section: Specific Deficiencies In Venous Ulcer Researchmentioning

confidence: 99%

mentioning

confidence: 99%

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Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research

Lazarus

Kirsner

Zenilman

et al. 2016

Wound Repair Regeneration

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“…The various approaches of surgeons to the selection of the extent of the operation with a shin trophic ulcer in place result in the aggravation of status localis in the near postoperative period in a number of cases, which compels to carry out long-term conservative treatment and justifies the need for solving this issue (Usenko, 2014). Moreover, the introduction of new, non-invasive methods of preoperative ultrasound diagnostics of the state of the lower extremity venous bed has allowed reconsidering the peculiarities of the functioning of the venous system during varicose disease and has become an incentive for the search for new methods and the reconsideration of the extents of the operative treatment of the condition (Bachoo, 2009;Mishalov, 2012;Malas, 2014). The issues of the application of varicose vein radio frequency ablation, as well as minimally invasive surgical correction methods remain unsolved (Nurmeev, 2014;Rasnussen, 2010).…”

Section: Introductionmentioning

confidence: 99%

Justification of the Need for Changing the CEAP Clinical Classification of Varicose Disease of the Lower Extremities and Adapting it to the Surgical Approach and the Selection of the Extent of the Operation

Riazanov¹,

Mamunchak²,

Iakunych³

et al. 2015

Adv. Sci.

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Abstract.The results of the examination and surgical treatment of 132 patients with CEAP class C2-C6 varicose disease of the lower extremities have been analyzed. A combined diagnostic method that allows detecting the peculiarities of the functioning of the perforating vein venous system of the shin, namely, allows establishing the uncompetency of the perforating veins of the shin objectively, has been developed. In view of the examination results obtained, a method of radical surgical treatment has been developed that allows individualizing, standardizing and synchronizing the extent of the surgical intervention depending on the stage of the disease, which results in a decrease in the injury rate and the duration of the operative intervention, ensuring the best results in the near and remote postoperative periods. A change in the CEAP classification has been proposed in order to adapt it to the surgical approach with a need to single out three clinical variants of stage С6: С6a, С6b and С6c, as well as the need to verify the competent "re-entry" perforating veins and the uncompetent perforating veins of the shin while designating them with "Apc" and "Apun" symbols respectively. In view of the innovations proposed an algorithm of the approach and selection of the extent of the surgical treatment of varicose disease depending on its clinical course has been developed.

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Venous Ulcers: General Information

Shiffman¹

2018

Recent Clinical Techniques, Results, and Research in Wounds

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Comparative effectiveness of surgical interventions aimed at treating underlying venous pathology in patients with chronic venous ulcer

Cited by 12 publications

References 22 publications

Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research

Clinical interventions for venous leg ulcers: Proposals to improve the quality of clinical leg ulcer research

Justification of the Need for Changing the CEAP Clinical Classification of Varicose Disease of the Lower Extremities and Adapting it to the Surgical Approach and the Selection of the Extent of the Operation

Venous Ulcers: General Information

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