[Evaluation of negative-pressure wound therapy]

Haute Autorité de Santé
Record ID 32016000286
French
Authors' objectives: Negative-pressure wound therapy (NPWT) consists in placing the surface of a wound under a pressure that is below ambient atmospheric pressure. This is done by connecting a specially designed dressing to a negative-pressure source and an exudate collection system. Integrated NPWT systems have been around for nearly twenty years. They are available as a substitute for the dressings usually used to treat acute or chronic wounds for limited periods in particular situations. Those situations mainly involve unsuturable wounds and wounds where healing by first intention fails. Use of NPWT is growing in hospital settings and is funded by hospitals through Diagnosis – related Groups. There are both strictly hospital applications and uses as part of home hospitalisation. In view of the implications for hospitals of the emergence of several competing NPWT systems and with users expecting good practice recommendations, the Haute Autorité de Santé decided to set about evaluating negative-pressure wound treatment.
Authors' recommendations: Since there are no clinical studies with a good level of evidence, this evaluation by the Haute Autorité de Santé (HAS) is based mainly on the expertise of a multidisciplinary working group made up of healthcare professionals. It takes account of the potential value of the technique in certain carefully selected patients. HAS has accepted limited-period uses targeting precisely defined clinical situations for certain chronic wounds (use as second-line therapy) or acute wounds (possible use as first-line therapy). The decision to use NPWT must be taken only after simpler conventional treatments have been considered or actually tried. In addition, a clear objective in terms of wound progress must be set when NPWT is started, accompanied by strict monitoring of that progress. If there is no improvement between two consecutive changes of dressing or after one week of use, the treatment must be stopped. NPWT must satisfy precise conditions of use. - Specific training is required for all caregivers, plus information for the patient about the objective of the treatment, its adverse effects and its constraints. - It must be prescribed following an opinion given by a specialist (plastic surgeon, dermatologist, diabetologist, etc.) and started in a healthcare establishment (it can then be continued in hospitalisation at home, with weekly assessment by the initial prescriber). - The maximum prescribed period is 30 days, repeatable just once by the initial prescriber. There are no clinical grounds for distinguishing between the different medical devices currently available on the market. Finally, set-ups using the hospital's central vacuum system (and not a specific integrated device) raise questions about the safety of their use and the reliability of the underpressure obtained. Although the opinions expressed by the experts were divided, HAS cannot recommend use of these techniques.
Details
Project Status: Completed
Year Published: 2010
English language abstract: An English language summary is available
Publication Type: Not Assigned
Country: France
MeSH Terms
  • Humans
  • Negative-Pressure Wound Therapy
  • Evaluation Study
Contact
Organisation Name: Haute Autorité de Santé
Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;
Contact Name: has.seap.secretariat@has-sante.fr
Contact Email: has.seap.secretariat@has-sante.fr
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.