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Protein-based tissue adhesive reduces time to haemostasis in peripheral vascular surgery
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Objectives
The aim of this study was to evaluate the effectiveness of protein-based tissue adhesive (Bioglue
®
) in reducing time to haemostasis in patients undergoing peripheral vascular surgery.
Methods
From January to December 2021, 100 consecutive patients from 4 centres have been treated with open peripheral vascular surgery including upper and lower limb interventions. Patients have been allocated in each centre into control with no use of Bioglue
®
(
Group no-Bio
, 50 patients) or use of Bioglue
®
(
Group Bio
, 50 patients) by a block randomization method 10:10 until the required sample size was reached. Perioperative parameters including time to haemostasis, number of adjunctive stitches, and in-hospital bleeding have been analysed and compared in the two groups by means of mean independent-samples
t
T -test and Gehan–Breslow–Wilcoxon test.
Results
Both groups were homogeneous in terms of demographic data, preoperative risk factors, and preoperative medical therapy except for a higher percentage of active smokers in
Group Bio
(52% vs. 24%,
p
= 0.004). Femoral endarterectomy was most common in
Group Bio
(44% vs. 24%,
p
= 0.03), whilst the percentage of lower limb vein bypasses was higher in
Group no-Bio
(50% vs. 36%,
p
= 0.03). Bovine pericardium was the preferred material in
Group Bio
(20 cases, 40%), whilst autologous vein is mostly used in
Group no-Bio
(26 cases, 52%) (
p
= 0.01). Time to haemostasis was faster in
Group Bio
(4.4 vs. 9.6 minutes,
p
< 0.001). The need for adjunctive stitches was higher in
Group no-Bio
(8 cases, 16%,
Group Bio
vs. 25 cases, 50%,
Group no-Bio
;
p
< 0.001). The overall rate of in-hospital bleeding, including those requiring reintervention, was not different between the two groups (9 cases, 18%,
Group Bio
vs. 7 cases, 14%,
Group no-Bio
;
p
= 0.39).
Conclusions
The protein-based tissue adhesive Bioglue
®
reduced time to haemostasis and need for adjunctive stitches in peripheral vascular surgery. However, it did not affect the overall rate of perioperative bleedings. Further studies with larger sample sizes are needed to validate these outcomes.
Title: Protein-based tissue adhesive reduces time to haemostasis in peripheral vascular surgery
Description:
Objectives
The aim of this study was to evaluate the effectiveness of protein-based tissue adhesive (Bioglue
®
) in reducing time to haemostasis in patients undergoing peripheral vascular surgery.
Methods
From January to December 2021, 100 consecutive patients from 4 centres have been treated with open peripheral vascular surgery including upper and lower limb interventions.
Patients have been allocated in each centre into control with no use of Bioglue
®
(
Group no-Bio
, 50 patients) or use of Bioglue
®
(
Group Bio
, 50 patients) by a block randomization method 10:10 until the required sample size was reached.
Perioperative parameters including time to haemostasis, number of adjunctive stitches, and in-hospital bleeding have been analysed and compared in the two groups by means of mean independent-samples
t
T -test and Gehan–Breslow–Wilcoxon test.
Results
Both groups were homogeneous in terms of demographic data, preoperative risk factors, and preoperative medical therapy except for a higher percentage of active smokers in
Group Bio
(52% vs.
24%,
p
= 0.
004).
Femoral endarterectomy was most common in
Group Bio
(44% vs.
24%,
p
= 0.
03), whilst the percentage of lower limb vein bypasses was higher in
Group no-Bio
(50% vs.
36%,
p
= 0.
03).
Bovine pericardium was the preferred material in
Group Bio
(20 cases, 40%), whilst autologous vein is mostly used in
Group no-Bio
(26 cases, 52%) (
p
= 0.
01).
Time to haemostasis was faster in
Group Bio
(4.
4 vs.
9.
6 minutes,
p
< 0.
001).
The need for adjunctive stitches was higher in
Group no-Bio
(8 cases, 16%,
Group Bio
vs.
25 cases, 50%,
Group no-Bio
;
p
< 0.
001).
The overall rate of in-hospital bleeding, including those requiring reintervention, was not different between the two groups (9 cases, 18%,
Group Bio
vs.
7 cases, 14%,
Group no-Bio
;
p
= 0.
39).
Conclusions
The protein-based tissue adhesive Bioglue
®
reduced time to haemostasis and need for adjunctive stitches in peripheral vascular surgery.
However, it did not affect the overall rate of perioperative bleedings.
Further studies with larger sample sizes are needed to validate these outcomes.
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