A single arm, prospective study of an absorbable cyanoacrylate surgical sealant for use in vascular reconstructions as an adjunct to conventional techniques to achieve haemostasis.

AIM

During vascular reconstructive surgery using ePTFE grafts, control of bleeding through suture holes may be time consuming and therefore costly. The ideal sealant has not yet been established. A prospective randomised trial using cyanoacrylate (ETHICON OMNEX Surgical Sealant) showed that the sealant was better than oxidized regenerated cellulose; therefore, a single-arm study to evaluate the performance of a cyanoacrylate surgical sealant in a range of vascular reconstructions was initiated.

METHODS

Patients undergoing AV access or vascular reconstruction below the diaphragm were included. The sealant was applied to a dry surgical field following completion of the anastomosis, and then allowed to set for 120 s prior to clamp removal. The primary endpoint was time from clamp release to haemostasis, defined as the absence of any detectable bleeding as determined by the surgeon. Secondary endpoints included the proportion of anastomotic sites achieving haemostasis within 0, 1, 5 and 10 min of post-clamp release, graft type used, frequency of adjunctive measures and number of each type of procedure. Safety endpoints included adverse events from operation until discharge or 48 h.

RESULTS

One hundred and ten (110) patients were enrolled at 5 centres; 5 were subsequently excluded from the study. In the remaining 105 patients, there were 157 evaluable anastomotic sites. Mean (SD) and median time to hemostasis by site was 23.2 (77.2) and 0.0 s, respectively. Immediate haemostasis was achieved in 71.3% (112/157) of sites and in 93.6%, 96.8% and 100% within 1, 5 and 10 min, respectively. In the analysis by graft material, haemostasis was immediate in 64.8%, 66.7% and 81.1% of sites in the PTFE, Dacron and autologous groups, respectively. Additional adjunctive measures were required in 3/158 (1.9%) sites in 3 patients. All had initially achieved haemostasis but intra-operative bleeding recurred. There were 12 adverse events, one of which was considered serious but unrelated to the device.

CONCLUSION

The time to haemostasis in this study was comparable to that reported in a previous publication. The cyanoacrylate surgical sealant was found to be safe and effective in a variety of vascular reconstruction procedures.