Multiphase preclinical assessment of a novel device to locate unintentionally retained surgical sharps: a proof-of-concept study

Table 2 In-Vivo Laparoscopic Phase Results

		X-ray + manual search (n = 9)	X-ray + MSF (n = 10)	MSF alone (n = 33)	P value
Needle size	9 mm	4 (44.4%)	5 (50%)	16 (48.4%)	0.97
Needle size	26 mm	5 (55.6%)	5 (50%)	17 (51.6%)	0.97
Needle present		7 (77.8%)	7 (70%)	21 (63.6%)	0.71
Needle absent		2 (22.2%)	3 (30%)	12 (36.3%)	0.71
Success: all		8/9 (88.9%)	10/10 (100%)	28/33 (84.5%)	0.42
Success if needle present		6/7 (85.7%)	7/7 (100%)	20/21 (95.2%)	0.49
Success if needle absent		2/2 (100%)	3/3 (100%)	8/12 (66.7%)	0.34
Time to determine (minutes)		2.2 ± 2.2	2.7 ± 2.1	2.8 ± 1.7	0.68

There was no statistically significant outcome in comparing the three groups using this laparoscopic porcine model. The MSF was non-inferior to the X-ray groups in determining the presence of a needle.

ISSN: 1754-9493