Negative Pressure Wound Therapy Devices

Technology Assessment Report

Technology assessment on negative pressure wound therapy devices.

Project ID: WNDT1108

Original date: May 26, 2009 ( PDF file PDF version - 3.53 MB )

Correction date: November 12, 2009*

*Go to Errata (PDF) [ PDF file - 9.55 KB] 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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Rockville, Maryland 20850

Current as of November 2009
Internet Citation: Negative Pressure Wound Therapy Devices: Technology Assessment Report. November 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/research/findings/ta/negative-pressure-wound-therapy/index.html