Safety and effectiveness of a synthetic hemostatic patch for intraoperative soft tissue bleeding

Figures & data

Figure 1 Subject flow.

Notes: The total number of subjects that were screened and that consented to the study was 37. Of those, seven were screen failures. The other 30 subjects were treated with Veriset™ hemostatic patch and assessed according to the procedures in the Material and methods section of this article; however, one subject died (unrelated to use of the device) before the 7-day follow-up and another subject was lost to follow-up before the final 90-day postoperative assessment.
Abbreviations: n, number of subjects; TBS, target bleeding site.

Table 1 Characterization of TBS

Parameter	Type of statistic	Veriset™ hemostatic patch (N=30)
Source(s) of bleedinga
Arterial	n (%)	1 (3.3)
Venous	n (%)	9 (30.0)
Resection/dissection field	n (%)	29 (96.7)
Tissue type(s)a
Tumor bed	n (%)	8 (26.7)
Organ bed	n (%)	18 (60.0)
Other	n (%)	8 (26.7)
Bleeding severity
Type 1	n (%)	0 (0.0)
Type 2	n (%)	22 (73.3)
Type 3	n (%)	8 (26.7)
Type 4	n (%)	0 (0.0)
Approximate area of TBS (cm^2)	N	30
	Mean	20.26
	Median	6.75
	SD	38.48
	Range	0.1–200.0
Conventional methods useda
None	n (%)	4 (13.3)
Cautery	n (%)	26 (86.7)
Clips	n (%)	9 (30.0)
Staples	n (%)	1 (3.3)
Suture/ligature	n (%)	8 (26.7)

Note:

a Percentages may sum to more than 100% since more than one category may apply.

Abbreviations: TBS, target bleeding site; N, total number of subjects in study; n, number of subjects; SD, standard deviation.

Table 2 Bleeding severity and number of layers of gauze penetrated by blood

Parameter	Bleeding severity	Type of statistic	Veriset™ hemostatic patch (N=30)
Layers of gauze that blood penetrated	Type 1	n	0
	Type 2	n	22
		Mean	8.0
		Median	8.0
		SD	4.4
		Range	3–21
	Type 3	n	8
		Mean	20.1
		Median	16.0
		SD	12.0
		Range	8–39
	Type 4	n	0

Abbreviations: N, total number of subjects in study; n, number of subjects; SD, standard deviation.

Figure 2 Kaplan–Meier analysis of time to hemostasis.

Notes: After the application of Veriset™ hemostatic patch, hemostasis was assessed every 30 seconds for the first 5 minutes and every 1 minute for minutes 5–10. All subjects achieved hemostasis within 6.0 minutes, and only three subjects required longer than 2.0 minutes to achieve hemostasis.

Table 3 Effectiveness of Veriset™ hemostatic patch

Parameter	Type of statistic	Veriset™ hemostatic patch (N=30)
Proportion of subjects achieving hemostasis at TBS within 5 minutes	n/N (%) 95% CI for %a P-valueb	29/30 (96.7) (82.8–99.9) <0.0001
Proportion of subjects achieving hemostasis at TBS within 1 minute	n/N (%) 95% CI for %a P-valueb	21/30 (70.0) (50.6–85.3) 0.0214
Time to hemostasis for TBS (minutes)	Medianc 95% CI for Mediand	1.0 0.5–1.0

Notes:

a Clopper–Pearson exact confidence interval;

b P-value from one-sided exact test based on the binomial distribution to test that the true percent success rate is ≤50% versus the alternative hypothesis that the success rate is >50%;

c Kaplan–Meier estimate of the median;

d Brookmeyer–Crowley CI for the median.

Abbreviations: TBS, target bleeding site; n, number of subjects; N, total number of subjects in study; CI, confidence interval.

Table 4 Adverse events

Parameter	Type of statistic	Veriset™ hemostatic patch (N=30)
Adverse events	n (%)	23 (76.7)
Serious adverse events	n (%)	11 (36.7)
Device-related adverse eventsa	n (%)	1 (3.3)
Unanticipated adverse device effects	n (%)	0 (0.0)
Device-related serious adverse events per subject during the 30 days after surgery	n/N (%)	0/30 (0.0)
Reoperation for device-related bleeding complications during the 5 days after surgery	n/N (%)	0/30 (0.0)

Note:

a Device-related adverse events are events with a definite, probable, possible, unknown/impossible to determine, or missing relationship to the device.

Abbreviations: n, number of subjects; N, total number of subjects in study.