Preliminary report for vacuum wounds therapy by IQWiG in Germany

For more than 20 years, vacuum therapy has been used on wounds in clinics, and over 100 studies have been completed. Nevertheless, statements about benefit and harm are to some extent uncertain because study leaders keep results under wraps.

According to the preliminary report on wounds healing by secondary intention, published by the Institute for Quality and Efficiency in Health Care IQWiG in August 2018, more than half of all participants in the manufacturer-funded studies had missing data. Also, 40% of Investigator Initiated Trials, studies, which were introduced by researchers working at universities, had missing data as well. At that time, IQWiG repeatedly requested this data in vain from the ones responsible.

Now that the manufacturer KCI (Acelity) has finally provided enough information, IQWiG sees a higher benefit in the negative pressure wound therapy (NPWT).

A systematic literature search for primary literature sources was carried out in the databases MEDLINE, Embase and Cochrane Central Register of Controlled Trials. In parallel, a search for relevant systematic reviews was carried out in the databases MEDLINE, Embase, Cochrane Database of Systematic Reviews and HTA Database. For the benefit assessment, a total of 12 randomized controlled trials (RCTs) and 16 nonrandomized trials were identified.

Results:

• Wound healing: positive wound healing results have been reported in 14 studies. In the joint evaluation of the studies with moderate and high qualitative reliability of results, there was a statistically significant difference between the two treatment groups in favor of vacuum wounds therapy (OR: 1.56, 95% CI [1,15; 2,13]). Moreover, in the totality of all studies, the duration of wound healing was significantly lower in cases when the vacuum therapy was used
• Reinterventions: results for the rate of reinterventions have been reported in 10 studies. In the joint evaluation of the studies with moderate and high qualitative reliability of results, there was a statistically significant difference in favor of vacuum therapy (OR: 0.46, 95% CI: [0.24, 0.86])
• Length of hospital stay: in the meta-analysis, there was a statistically significant difference in favor of vacuum therapy both in the study with high-quality confidence (Llanos 2006) and in the totality of all studies (MD: -4.78, 95% CI: [-7.79 -1.76])
• However, there was no statistically significant difference in the joint evaluation of the studies with moderate and high qualitative reliability of results concerning the mortality, bleeding, infection, amputation, pain, duration of stay in the intensive care unit, rehospitalization, health-related quality of life and function

At the same time as the final report on the wounds healing by secondary intention, the IQWiG published the preliminary report on the wounds healing by primary purpose. The preliminary report will be revised, sent to the Federal Joint Committee (the G-BA) as the final report and published on the IQWiG website eight weeks later.

The full details in German can be found here.

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