Technology Assessment: Negative Pressure Wound Therapy Devices

Negative Pressure Wound Therapy Devices
Technology Assessment Report
Project ID: WNDT1108

May 26, 2009

ECRI Institute
Nancy Sullivan, BA
David L. Snyder, Ph D
Kelley Tipton, MPH
Stacey Uhl, MSS
Karen M. Schoelles, MD SM

This report is based on research conducted by the ECRI Institute under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10063). 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.

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.

Katherine R. Jones, RN, Ph.D.
Sarah Cole Hirsh Professor Associate Dean for Evidence-based Practice
Case Western Reserve University
Bolton School of Nursing
Cleveland, Ohio

David Margolis, MD PhD
Professor of Dermatology and Epidemiology
University of Pennsylvania
Philadelphia, Pennsylvania

Gerit Mulder, DPM, MS, APWCA
Director, Wound Treatment and Research Center at the Regional Burn Center
University of California San Diego
San Diego, California

Catherine Ratliff
PhD, APRN-BC
University of Virginia
Charlottesville, Virginia

Contents
Tables
Figures
Executive Summary
Methods of the Review
Evidence for Negative Pressure Wound Therapy
Conclusion
References
Abbreviations and Acronyms
Background
Chronic and Acute Wounds
Diabetic Foot Ulcers
Pressure Ulcers
Venous Leg Ulcers
Surgical Wounds
Burns
Trauma Wounds
Phases of Normal Wound Healing
Negative Pressure Wound Therapy
Principles of NPWT
Contraindications of NPWT
Negative Pressure Wound Therapy Systems
Complementary or Competing Products
Standard Treatments
Synthetic Wound Dressings
Antimicrobial Wound Dressings
Skin Grafts and Skin Substitutes
Methods
Key Questions
Analytic Framework
Inclusion Criteria
Search Strategy
Study Quality Assessment
Data Synthesis
Results
Key Question 1: Does any single NPWT system have a significant therapeutic distinction in terms of wound healing outcomes compared to any other NPWT system for the treatment of acute or chronic wounds?
Quantitative Synthesis of the Evidence Base
Qualitative Synthesis of the Evidence Base
Was an indirect comparison possible?
Key Question 2: Does any component of a NPWT system have a significant therapeutic distinction compared to any other similar component of a NPWT system for the treatment of acute or chronic wounds?
Key Question 3: What are the reported occurrences of pain, bleeding, infection, other complications, and mortality for NPWT systems?
Key Question 4: Do patients being treated with one NPWT system have a significant therapeutic distinction in terms of less pain, bleeding, infection, other complications, or mortality than other NPWT systems?
Stakeholder Submissions
Previous Systematic Reviews
Quality of the Systematic Reviews
Findings of the Systematic Reviews
High Quality Reviews
Moderate Quality Reviews
Meta-Analysis
Adverse Events
Overview of the Systematic Reviews
Ongoing Clinical Trials
Discussion and Conclusions
References (225 KB)
Appendix A
Electronic Database Searches
Hand Searches of Journal and Nonjournal Literature
Appendix B
Appendix C (480 KB)
Appendix D (655 KB)

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Technology Assessment: Negative Pressure Wound Therapy Devices