Cyanoacrylate skin microsealant for preventing surgical site infection after vascular surgery: a discontinued randomized clinical trial.
BACKGROUND
Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a cyanoacrylate preparation at the site of surgery on the incidence of SSI after arterial reconstruction.


METHODS
Patients scheduled for vascular reconstruction in or distal to the groin were randomized into a treatment and a control group. Standard measures for preventing contamination of the surgical field were taken in the control group, whereas cyanoacrylate was used as a skin sealant at the surgical site in the patients in the treatment group. We hypothesized that the incidence of SSI with the use of cyanoacrylate would be two-thirds (67%) lower than that with standard preparation of the surgical site, and performed an interim analysis of 50 patients to assess this.


RESULTS
Risk factors among the 50 patients in the study included smoking (28%), hypertension (77%), diabetes mellitus (36%), and hypercholesterolemia (74%). Indications for surgery were invalidating claudication (Fontaine IIb), pain at rest, or tissue necrosis. The overall incidence of SSI was 3/47 (6%), without differences between groups; 9% SSIs in the control group versus 4% SSIs in the intervention group.


CONCLUSIONS
We could not confirm a reduction in the incidence of SSI after inguinal vascular surgery with the use of a cyanoacrylate skin sealant as compared with conventional means for preparing the surgical site.
1 Department of Surgery, Wilhelmina Hospital , Assen, The Netherlands .
Bastiaan P
BP
Vierhout
Alewijn
A
Ott
Michel M P J
MM
Reijnen
Jacques
J
Oskam
Alewijn
A
Ott
Jan J A M
JJ
van den Dungen
Clark J
CJ
Zeebregts
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003487:Cyanoacrylates / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D013530:Surgical Wound Infection / Q000453:epidemiology / Q000517:prevention & control*; D014218:Triage / Q000379:methods*; D014656:Vascular Surgical Procedures / Q000009:adverse effects*; D058106:Wound Closure Techniques
D003487:Cyanoacrylates