negative pressure wound therapy technologies for chronic

Download Negative Pressure Wound Therapy Technologies For Chronic

Post on 12-Jan-2017

220 views

Category:

Documents

4 download

Embed Size (px)

TRANSCRIPT

  • Technology Assessment

    Technology

    Assessment Program Prepared for: Agency for Healthcare Research and Quality 540 Gaither Road Rockville, Maryland 20850

    Negative Pressure Wound Therapy Technologies For Chronic Wound Care in the Home Setting

    September 15, 2014

  • Negative Pressure Wound Therapy Technologies for

    Chronic Wound Care in the Home Setting

    Technology Assessment Report

    Project ID: WNDT0913

    September 15, 2014

    Johns Hopkins University Evidence-based Practice Center

    Susan M. Rhee, M.D. M. Frances Valle, D.N.P., M.S.

    Lisa M. Wilson, Sc.M. Gerald Lazarus, M.D.

    Jonathan M. Zenilman, M.D. Karen A. Robinson, Ph.D.

    This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (HHSA 290-201-200007-I). The findings and conclusions in this document are those of the author(s) who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. No statement in this article should be construed as an official position of the Agency for Healthcare Research and Quality or of the U.S. Department of Health and Human Services. The information in this report is intended to help health care decision-makers; patients and clinicians, health system leaders, and policymakers, make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Decisions concerning the provision of clinical care should consider this report in

  • the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients. This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

    None of the investigators has any affiliations or financial involvement related to the material presented in this report. This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated. Persons using assistive technology may not be able to fully access information in this report. For assistance contact TAP@ahrq.hhs.gov. Suggested citation: Rhee SM, Valle MF, Wilson LM, Lazarus G, Zenilman J, Robinson KA. Negative Pressure Wound Therapy Technologies For Chronic Wound Care in the Home Setting. Evidence Report/Technology Assessment. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-201-200007-I.) Rockville, MD: Agency for Healthcare Research and Quality. August 2014. www.ahrq.gov.

  • Acknowledgments We would like to thank Oluwaseun Shogbesan for her assistance in reviewing articles and

    Faye Rivken for copy editing. We would also like to thank the Peer Reviewers, the Task Order Officer, and representatives from CMS.

    Peer Reviewers We wish to acknowledge individuals listed below for their review of this report. This report has been reviewed in draft form by individuals chosen for their expertise and diverse perspectives. The purpose of the review was to provide candid, objective, and critical comments for consideration by the EPC in preparation of the final report. Synthesis of the scientific literature presented here does not necessarily represent the views of individual reviewers. Jiyoung M. Dang, Ph.D. Supervisory Biomedical Engineering Food and Drug Administration Silver Spring, MD William Li, M.D. President and Medical Director The Angiogenesis Foundation Cambridge, MA Paul Y. Liu, M.D. Chair, Department of Plastic and Reconstructive Surgery Brown University Providence, RI Nasrin Mirsaidi, R.N., M.S.N., C.N.O.R. Physical Scientist Food and Drug Administration Silver Spring, MD

    Simon Palfreyman, B.Sc., R.G.N., M.Sc., Ph.D. Clinical Lecturer Sheffield Teaching Hospitals NHS Foundation Trust/University of Sheffield Sheffield, UK Jeffrey M. Robbins, D.P.M. Director, Podiatry Service VACO Louis Stokes Cleveland VAMC Cleveland, OH Karen Schoelles, M.D., S.M. Director, ECRI Institute-Penn Medicine Evidence-based Practice Center ECRI Institute Plymouth Meeting, PA Terry Treadwell, M.D., F.A.C.S. Medical Director Institute for Advanced Wound Care Montgomery, AL

    iv

  • Negative Pressure Wound Therapy Technologies for Chronic Wound Care in the Home Setting Structured Abstract Objectives: To systematically review the efficacy and safety of negative pressure wound therapy (NPWT) for treatment of chronic wounds in the home setting. Data Sources: On June 2014, we searched MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and the Cumulative Index to Nursing and Allied Health Literature (CINAHL). Review Methods: Two independent reviewers screened search results. We included studies examining the use of NPWT in patients with chronic wounds, including venous leg ulcers, arterial leg ulcers, diabetic foot ulcers, pressure ulcers, and mixed etiology chronic wounds. We searched for comparative trials that followed subjects in the home setting. We extracted data into standardized forms and summarized results qualitatively. Results: We retrieved 5,912 citations, and found seven studies which met our criteria for inclusion. Six of the studies compared NPWT devices to other wound care methods. One study compared two different NPWT devices. Data were limited by variability in the types of comparator groups, variable quality in study design, and limited reporting of outcomes. Conclusions: We were unable to draw conclusions about the efficacy or safety of NPWT for the treatment of chronic wounds in the home setting due to insufficient evidence. Though NPWT has been used across the wound care spectrum, significant research gaps remain. Standardization of wound care research protocols, such as providing consistency in comparator groups, robust randomized study designs, larger trials, and common definitions of outcomes, would be helpful in providing evidence to inform decisions about the use of NPWT.

    v

  • Contents Introduction ......................................................................................................................................1

    Scope and Key Questions ........................................................................................................... 2 Methods............................................................................................................................................6

    Protocol Development ................................................................................................................ 6 Search Strategy ........................................................................................................................... 6 Study Selection ........................................................................................................................... 6 Data Extraction ........................................................................................................................... 6 Quality (Risk of Bias) Assessment of Individual Studies ........................................................... 9 Data Synthesis ............................................................................................................................. 9 Strength of the Body of Evidence ............................................................................................... 9 Applicability ............................................................................................................................. 10 Peer Review and Public Commentary ...................................................................................... 10

    Results ............................................................................................................................................11 Search Results ........................................................................................................................... 11 Negative Pressure Wound Therapy Technologies Commercially Available in the U.S. ......... 13 Home Use of Negative Pressure Wound Therapy Compared With Other Wound Care Methods..................................................................................................................................... 14 Wound Care Modalities Used Prior To Or With Intervention .................................................. 22 Characteristics of Negative Pressure Wound Therapy Compared With Other Characteristics 22

    Discussion ......................................................................................................................................27 Key Findings and the Strength of Evidence ............................................................................. 27 Findings in Relationship to What is Already Known ............................................................... 28 Applicability ............................................................................................................................. 29 Limitations of the Review Process ........................................................................................... 29 Limitations of the Evidence Base ............................................................................................. 30 Research Gaps ..........................................................................................................................

Recommended

View more >