Cyanoacrylat, HTA report 2013:8
Surgical site infection is a common problem in health care. Results from prevalence measurements of care-related infections in Sweden have demonstrated that surgical site infections comprise 25% of them. Many hygiene routines have been developed to minimize this problem.
As addition to regular preoperative skin care cyanoacrylate (InteguSeal®, Kimberly-Clark Health Care) was introduced in 2006. It is a film-forming liquid that is supposed to lock down bacteria residing deep in the skin as well as those surviving typical pre-operative preparation. This report evaluates the scientific evidence for this addition.
A systematic literature search identified 41 articles of which 33 were excluded by the information specialists as they did not fulfill the PICO or other eligibility criteria. Eight articles were assessed by the project group. Six articles were assessed to be of low quality. Three of them (scoliosis, inguinal hernia and vein harvesting) were randomized.
Two cardiac surgery articles were of medium quality. In a single center study by Waldow et al., two prospective registries were used to evaluate the effect of cyanoacrylate on the incidence of mediastinitis and other form of SSI after cardiac surgery. 998 consecutive patients were included, randomized with risk for bias (treatment/control on alternating days), with low dropout rates and similar risk factors in both groups. Mediastinitis was reported in 2.3 vs 3.2% (n.s.) and other SSI in 10.9 and 11.5% (n.s.).
von Eckardstein conducted a randomized, controlled, parallel group, multicenter, open-label trial and enrolled 300 adults for elective cardiac surgery. SSI was a secondary outcome and surgical techniques varied between participating clinics. Randomization was relevant, drop-outs were few and no significant differences were found in sternal or graft site SSI. Total SSI frequency was 6.2 vs 9.5% (n.s.).
Cyanoacrylate does not reduce surgical site infections in cardiac surgery. The level of evidence according to GRADE is low (⊕⊕). The evidence for other surgical procedures is very low (⊕).
This Health Technology Assessment has been conducted by a Bengt Gårdlund, infectious disease specialist, PO Nyström, specialist in gastrointestinal surgery and Ann Tammelin, specialist in infections control and hospital hygiene, in cooperation with Claes Lennmarken and Elisabeth Persson, both medical advisers at the HTA-center in Stockholm County Council – Region Gotland, Sweden.
- Supplementary information: Included and excluded articles, search strategy, search documentation and the full text publication in Swedish with contact addresses are located as links over the document header.