A Health Technology Assessment was performed by a group consisting of an infection specialist, a surgeon and a specialist in infection control and hospital hygiene - all with scientific qualifications – working together with the HTA center.
A systematic literature search identified 55 articles. Of these, 47 were excluded by the information specialists as they did not fulfill the eligibility criteria. The remaining eight articles were read by the project group, which excluded four of them as their content did not correspond to PICO or was of low quality.
The remaining four RCT studies of high or medium quality were assessed. All patients included in the meta-analysis had elective colorectal surgery or open acute appendectomy. The Centers for Disease Control and Prevention (CDC) criteria for classification of infections were used in all of the studies. Antibiotic prophylaxis was given and assessors were blinded.
Results of the four randomized studies by Reid et al., Horiuchi et al., Lee et al. and Chen et al. (n=395) were included in a meta-analysis. The relative risk of superficial SSI with the Alexis wound protector was 0.15 (95 % confidence interval (CI) 0.06-0.39). The number needed to treat was seven (95 % CI 5-11).
The conclusion of the assessment is that the Alexis wound protector had a beneficial effect with statistically lower incidence of SSI (p<0.001) in open colorectal surgery and open acute appendectomy. The number needed to treat was seven. The level of evidence according to GRADE was moderate ⊕⊕⊕.
Regarding deep wound infections and intra-abdominal infections, the questions about protection could not be answered due to the very low quality of evidence ⊕.