Prospective randomized study of a protein-based tissue adhesive used as a hemostatic and structural adjunct in cardiac and vascular anastomotic repair procedures.
Level 2 - randomized trial
Individual multicenter randomized controlled trial
PubMed 12892806 · doi:10.1016/S1072-7515(03)00376-4
What was done
Patients undergoing cardiac and vascular repair procedures across multiple centers were enrolled in a prospective randomized controlled trial. A total of 151 patients were randomized to standard repair plus BioGlue (a bovine serum albumin and glutaraldehyde surgical adhesive; n = 76) or standard repair alone (n = 75). Procedures included cardiac (n = 49), aortic (n = 105), and peripheral vascular (n = 48) repairs. Evaluated outcomes included anastomotic bleeding rates, pledget use, length of stay, and adverse events.
What was found
Anastomotic bleeding was significantly reduced in the BioGlue group (18.8% of anastomoses) compared with the control group (42.9% of anastomoses, p < 0.001). Pledget use was also significantly lower in the BioGlue group (26.2% vs. 35.9%, p = 0.047). ICU and total hospital days were reported as slightly higher in controls, but exact values were not reported in the abstract. Adverse event rates were equivalent overall, except for neurological defects, which occurred threefold less frequently in the BioGlue group (p = 0.009).
Why it matters
This study provides prospective randomized evidence that BioGlue safely improves intraoperative hemostasis and reduces reinforcement pledget use along cardiovascular suture lines.
Limits
Surgical blinding was not feasible given the nature of the topical adhesive. Exact numbers and confidence intervals for length of stay and specific adverse events were not reported in the abstract. Long-term graft integrity and late adverse outcomes were not described.
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