Negative Pressure Wound Therapy Devices Technology Assessment ReportTechnology assessment on negative pressure wound therapy devices. Project ID: WNDT1108Original date: May 26, 2009Correction date: November 12, 2009*Technology Assessment: Negative Pressure Wound Therapy Devices ( PDF version - 3.53 MB; Plugin Software Help)*Go to Errata document ( PDF version - 9.55 KB; Plugin Software Help) for a summary of the corrections.ECRI InstituteNancy Sullivan, BADavid L. Snyder, Ph DKelley Tipton, MPHStacey Uhl, MSSKaren M. Schoelles, MD SMThis 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 ReviewersWe 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 PracticeCase Western Reserve UniversityBolton School of NursingCleveland, OhioDavid Margolis, MD PhDProfessor of Dermatology and EpidemiologyUniversity of PennsylvaniaPhiladelphia, PennsylvaniaGerit Mulder, DPM, MS, APWCADirector, Wound Treatment and Research Center at the Regional Burn CenterUniversity of California San DiegoSan Diego, CaliforniaCatherine RatliffPhD, APRN-BCUniversity of VirginiaCharlottesville, VirginiaContentsTablesFiguresExecutive Summary Methods of the Review Evidence for Negative Pressure Wound Therapy ConclusionReferencesAbbreviations and AcronymsBackground 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 SubstitutesMethods Key Questions Analytic Framework Inclusion Criteria Search Strategy Study Quality Assessment Data SynthesisResults 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 SubmissionsPrevious 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 ReviewsOngoing Clinical TrialsDiscussion and ConclusionsReferences (225 KB)Appendix A Electronic Database Searches Hand Searches of Journal and Nonjournal LiteratureAppendix BAppendix C (480 KB)Appendix D (655 KB) TablesTable 1. Negative Pressure Wound Therapy Devices Marketed in the U.S.Table 2. Negative Pressure Wound Therapy Systems: Indications and ContraindicationsTable 3. Negative Pressure Wound Therapy Device Product Description (information obtained from manufacturer Web sites)Table 4. Study Quality Categories by Overall Quality of Evidence BaseTable 5. Reports of Pain in Comparison Studies of NPWT DevicesTable 6. Reports of Bleeding in Comparison Studies of NPWT DevicesTable 7. Reports of Infection in Comparison Studies of NPWT DevicesTable 8. Reports of Mortality in Comparison Studies of NPWT DevicesTable 9. Reports of Other Complications in Comparison Studies of NPWT DevicesTable 10. Other Complications Reported in Case StudiesTable 11. Summary of ConclusionsTable 12. Clinical Trials Appendix AElectronic Database SearchesTopic-specific Search TermsEMBASE/MEDLINE: Human, English LanguagePubMed: English Language, In Process/PublisherTable 13. Excluded StudiesTable 14. Summary of Stakeholder Solicitations and ResponsesTable 14a. Total Stakeholder Solicitations and Responses Appendix BTable 15. Answers to Quality Assessment of Controlled Studies Comparing NPWT to Comparative TreatmentsTable 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 BottleTable 15c. Answers to Quality Assessment of a Controlled Study Comparing NPWT to a Redon BottleAppendix CTable 16. Comparison Trials of NPWT Devices Used to Treat Chronic WoundsTable 17. Comparison Trials of NPWT Used to Treat Acute WoundsTable 18. Comparison Trials of NPWT Devices Used to Secure Skin GraftTable 19. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic WoundsTable 20. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic WoundsTable 21. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic WoundsTable 22. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Miscellaneous Chronic WoundsTable 23. Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure UlcersTable 24. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure UlcersTable 25. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure UlcersTable 26. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Diabetic Foot and Pressure UlcersTable 27. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Secure Skin GraftTable 28. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Secure Skin GraftTable 29. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Secure Skin GraftTable 30. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Secure Skin GraftTable 31. Key Study Design Characteristics of Comparison Studies of NPWT Devices* Used to Treat Acute WoundsTable 32. Patient Characteristics in Comparison Studies of NPWT Devices* Used to Treat Acute WoundsTable 33. Treatment-Related Characteristics in Comparison Studies of NPWT Devices* Used to Treat Acute WoundsTable 34. Results for Outcome Measures Reported in Comparison Studies of NPWT Devices* Used to Treat Acute WoundsTable 35. Characteristics of Patients with Acute WoundsTable 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 TypesTable 37. Outcomes Reported for all Wound TypesTable 38. Adverse Events Reported for all Wound TypesTable 39. Characteristics of Systematic Reviews of NPWT Devices—High Quality ReviewsTable 39a. Characteristics of Systematic Reviews of NPWT Devices—Moderate Quality ReviewsTable 39b. Characteristics of Systematic Reviews of NPWT Devices—Low Quality ReviewsTable 40. Study Inclusion in Systematic ReviewsTable 41. Quality of Systematic ReviewsTable 42. Adverse Events Described in Systematic Reviews Appendix DTable 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: PublicationsTable 46. Status of CMS submission: Government DocumentsTable 47. Status of CMS submission: Miscellaneous MaterialTable 48. Status of CMS submission: Material from KCI or related to KCITable 49. Status of CMS submission: Material from BlueSky or related to BlueSkyTable 50. Status of Submission by ConvaTecTable 51. Status of Submission by IndividualsTable 52. Status of Submission by MedelaTable 53. Status of Submissions by ProsperaTable 54. Status of Submissions by Smith and NephewTable 55. Status of Submission by Talley Group, Ltd.FiguresFigure 1. Analytic FrameworkFigure 2. Disposition of Articles Identified by Internal Searches and Outside SubmissionsFigure 3. Analytic FrameworkFigure 4. Disposition of Articles Identified by Internal Searches and Outside SubmissionsFigure 5. Disposition of Items Submitted by Interested StakeholdersFigure 6. Disposition of Submission by American Association for the Advancement of Wound CareFigure 7. Disposition of Submission by Kinetic Concepts, Inc.Figure 8. Disposition of Submission by CMSFigure 9. Disposition of Submission by ConvaTecFigure 10. Disposition of Submission by IndividualsFigure 11. Disposition of Submission by Medela, Inc.Figure 12. Disposition of Submission by ProsperaFigure 13. Disposition of Submission by Smith & NephewFigure 14. Disposition of Submission by Talley Group Ltd.Top of PageList of devices names*ActiV.A.C.® Therapy UnitEngenex® Advanced NPWT SystemExusdex® wound drainage pumpEZCARE Negative Pressure Wound TherapyInfoV.A.C.® Therapy UnitInvia Liberty Wound TherapyInvia Vario 18 c/i Wound TherapyMini V.A.C.®NPD 1000 Negative Pressure Wound Therapy SystemProdigy™ NPWT System (PMS-800 and PMS-800V)PRO-I™PRO-II™PRO-III™RENASYS™ EZ Negative Pressure Wound TherapySVEDMAN™ and SVED™ Wound Treatment SystemsV.A.C.® ATS™V.A.C.® Freedom™V.A.C.® Instill DeviceV.A.C.® Therapy UnitV.A.C.® (Vacuum Assisted Closure™)V1STA Negative Pressure Wound TherapyVenturi™ 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 Quality540 Gaither RoadRockville, 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