Authors' objectives:

This study sought: to assess the efficacy and safety of negative pressure in the treatment of chronic wounds, in the light of the current state of knowledge; to identify selection criteria for candidate patients; and to draw up recommendations for use in our socio-healthcare context.

Authors' results and conclusions: Eight randomized clinical trials (n=182) were selected, in which negative pressure had been used in the treatment of patients with pressure ulcers, diabetic foot, and chronic wounds of varying etiologies, or for consolidation of skin grafts. All trials were classified as Level II or III under Jovell's scientific quality scale, on obtaining a mean Jadad scale score of 2.62 out of five. Generally speaking, better healing was observed in the group of patients treated with negative pressure, with shallower ulcer depth and a decrease in both volume and surface area, though this was seldom statistically significantly due, probably, to the small sample size of the studies. Treatment complications were reported in only six of the eight trials, with the most frequently described adverse effects being bleeding and pain during sponge changes, allergic reactions, and depletion of liquids, along with some cases of osteomyelitis and infected wounds. We also located four Assessment Agency reports, one systematic review, and a further new assessment report, published after this paper had gone to press. In terms of its indication, this technology should be solely used among patients with Stage III or IV pressure ulcers, diabetic ulcers, or chronic venous ulcers that are evolving unfavorably despite receiving standard treatment measures in the preceding thirty days.

Authors' recommendations: At present, existing clinical trials on negative-pressure treatment of chronic wounds show poor methodological quality and a sample size too small for detection of statistically significant differences between this technique and conventional treatments. Hence, though there would appear to be some evidence of its superiority, the above reasons could bring the validity of the results into question and cause the technique's clinical efficacy to be seen as uncertain. One must thus conclude that, currently, insufficient scientific evidence exists to allow for negative pressure to be recommended in standard treatment of chronic wounds of differing etiology, and that, for proper assessment of this technique, multicenter, randomized clinical trials with good methodological design and the necessary statistical power are called for.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.sergas.es/MostrarContidos_N3_T02.aspx?IdPaxina=60058&uri=http://www.sergas.es/gal/Servicios/docs/AvaliacionTecnoloxias/VAC%20CT2005_01.pdf&hifr=750&seccion=0

Year Published: 2005

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Spain

Organisation Name: Scientific Advice Unit, avalia-t; The Galician Health Knowledge Agency (ACIS)

Contact Address: Conselleria de Sanidade, Xunta de Galicia, San Lazaro s/n 15781 Santiago de Compostela, Spain. Tel: 34 981 541831; Fax: 34 981 542854;

Contact Name: avalia-t@sergas.es

Contact Email: avalia-t@sergas.es

Copyright: Galician Agency for Health Technology Assessment (AVALIA-T)