Technology Assessment Report
Project ID: WNDT1108
Original date: May 26, 2009
Correction date: November 12, 2009*
Technology Assessment:
Negative Pressure Wound Therapy Devices (PDF
File, 3.6 MB; PDF
Help)
*Go to Errata document (PDF
file, 10 KB; PDF Help) for a summary of the
corrections.
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)
Tables
Table 1. Negative Pressure Wound Therapy Devices
Marketed in the U.S.
Table 2. Negative Pressure Wound Therapy Systems:
Indications and Contraindications
Table 3. Negative Pressure Wound Therapy Device
Product Description (information obtained from manufacturer Web sites)
Table 4. Study Quality Categories by Overall Quality
of Evidence Base
Table 5. Reports of Pain in Comparison Studies
of NPWT Devices
Table 6. Reports of Bleeding in Comparison Studies
of NPWT Devices
Table 7. Reports of Infection in Comparison Studies
of NPWT Devices
Table 8. Reports of Mortality in Comparison Studies
of NPWT Devices
Table 9. Reports of Other Complications in Comparison
Studies of NPWT Devices
Table 10. Other Complications Reported in Case
Studies
Table 11. Summary of Conclusions
Table 12. Clinical Trials
Appendix A
Electronic Database Searches
Topic-specific Search Terms
EMBASE/MEDLINE: Human, English Language
PubMed: English Language, In Process/Publisher
Table 13. Excluded Studies
Table 14. Summary of Stakeholder Solicitations
and Responses
Table 14a. Total Stakeholder Solicitations
and Responses
Appendix B
Table 15. Answers to Quality Assessment of Controlled
Studies Comparing NPWT to Comparative Treatments
Table 15a. Answers to Quality Assessment of
Controlled Studies Comparing NPWT to Comparative Treatments (Continued)
Table 15b. Answers to Quality Assessment of
a Controlled Study Comparing NPWT to a Redon Bottle
Table 15c. Answers to Quality Assessment of
a Controlled Study Comparing NPWT to a Redon Bottle
Appendix C
Table 16. Comparison Trials of NPWT Devices
Used to Treat Chronic Wounds
Table 17. Comparison Trials of NPWT Used to
Treat Acute Wounds
Table 18. Comparison Trials of NPWT Devices
Used to Secure Skin Graft
Table 19. Key Study Design Characteristics of
Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds
Table 20. Patient Characteristics in Comparison
Studies of NPWT Devices* Used to Treat Miscellaneous Chronic Wounds
Table 21. Treatment-Related Characteristics
in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic
Wounds
Table 22. Results for Outcome Measures Reported
in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic
Wounds
Table 23. Study Design Characteristics of Comparison
Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure Ulcers
Table 24. Patient Characteristics in Comparison
Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure Ulcers
Table 25. Treatment-Related Characteristics
in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure
Ulcers
Table 26. Results for Outcome Measures Reported
in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure
Ulcers
Table 27. Key Study Design Characteristics of
Comparison Studies of NPWT Devices* Used to Secure Skin Graft
Table 28. Patient Characteristics in Comparison
Studies of NPWT Devices* Used to Secure Skin Graft
Table 29. Treatment-Related Characteristics
in Comparison Studies of NPWT Devices* Used to Secure Skin Graft
Table 30. Results for Outcome Measures Reported
in Comparison Studies of NPWT Devices* Used to Secure Skin Graft
Table 31. Key Study Design Characteristics of
Comparison Studies of NPWT Devices* Used to Treat Acute Wounds
Table 32. Patient Characteristics in Comparison
Studies of NPWT Devices* Used to Treat Acute Wounds
Table 33. Treatment-Related Characteristics
in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds
Table 34. Results for Outcome Measures Reported
in Comparison Studies of NPWT Devices* Used to Treat Acute Wounds
Table 35. Characteristics of Patients with Acute
Wounds
Table 35a. Characteristics of Patients with
Chronic Wounds (continued)
Table 35b. Characteristics of Patients with
Mixed Wound Types (continued)
Table 36. Treatment Details for All Wound Types
Table 37. Outcomes Reported for all Wound Types
Table 38. Adverse Events Reported for all Wound
Types
Table 39. Characteristics of Systematic Reviews
of NPWT Devices—High Quality Reviews
Table 39a. Characteristics of Systematic Reviews
of NPWT Devices—Moderate Quality Reviews
Table 39b. Characteristics of Systematic Reviews
of NPWT Devices—Low Quality Reviews
Table 40. Study Inclusion in Systematic Reviews
Table 41. Quality of Systematic Reviews
Table 42. Adverse Events Described in Systematic
Reviews
Appendix D
Table 43. Status of Submissions by American
Association for the Advancement of Wound Care
Table 44. Status of Submissions by Kinetic Concepts,
Inc.
Table 45. Status of CMS submission: Publications
Table 46. Status of CMS submission: Government
Documents
Table 47. Status of CMS submission: Miscellaneous
Material
Table 48. Status of CMS submission: Material
from KCI or related to KCI
Table 49. Status of CMS submission: Material
from BlueSky or related to BlueSky
Table 50. Status of Submission by ConvaTec
Table 51. Status of Submission by Individuals
Table 52. Status of Submission by Medela
Table 53. Status of Submissions by Prospera
Table 54. Status of Submissions by Smith and
Nephew
Table 55. Status of Submission by Talley Group,
Ltd.
Figures
Figure 1. Analytic Framework
Figure 2. Disposition of Articles Identified by Internal Searches and Outside
Submissions
Figure 3. Analytic Framework
Figure 4. Disposition of Articles Identified by Internal Searches and Outside
Submissions
Figure 5. Disposition of Items Submitted by Interested Stakeholders
Figure 6. Disposition of Submission by American Association for the Advancement
of Wound Care
Figure 7. Disposition of Submission by Kinetic Concepts, Inc.
Figure 8. Disposition of Submission by CMS
Figure 9. Disposition of Submission by ConvaTec
Figure 10. Disposition of Submission by Individuals
Figure 11. Disposition of Submission by Medela, Inc.
Figure 12. Disposition of Submission by Prospera
Figure 13. Disposition of Submission by Smith & Nephew
Figure 14. Disposition of Submission by Talley Group Ltd.
Top of Page
List of devices names*
ActiV.A.C.® Therapy Unit
Engenex® Advanced NPWT System
Exusdex® wound drainage pump
EZCARE Negative Pressure Wound Therapy
InfoV.A.C.® Therapy Unit
Invia Liberty Wound Therapy
Invia Vario 18 c/i Wound Therapy
Mini V.A.C.®
NPD 1000 Negative Pressure Wound Therapy System
Prodigy™ NPWT System (PMS-800 and PMS-800V)
PRO-I™
PRO-II™
PRO-III™
RENASYS™ EZ Negative Pressure Wound Therapy
SVEDMAN™ and SVED™ Wound Treatment Systems
V.A.C.® ATS™
V.A.C.® Freedom™
V.A.C.® Instill Device
V.A.C.® Therapy Unit
V.A.C.® (Vacuum Assisted Closure™)
V1STA Negative Pressure Wound Therapy
Venturi™ Negative Pressure Wound Therapy
* These devices have U.S. Food and Drug Administration 510(k) clearance for marketing
in the United States.
Prepared for:
Agency for Healthcare Research and Quality
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