Table 5.

SSI analysis by ‘ITT’ assuming (1) all and (2) none of the participants violating protocol or lost to follow-up would have developed SSI

	Antibiotic Prophylaxis	Control group	P values	Absolute risk reduction	95% CI	Relative risk reduction (%)	NNTB (95% CI)
Analysis by ITT: assuming all the participants violating protocol or lost to follow-up would have developed SSI
	n=77	n=77
No of SSI	n=1	n=8
Incidence rate of SSI	1.3%	10.4%	P=0.034*	9.1%	1.8 to 16.4	87.5	11.0 (6.1 to 55.6)
Analysis by ITT: assuming none of the participants violating protocol or lost to follow-up would have developed SSI
	n=77	n=77
No of SSI	n=5	n=16
Incidence rate of SSI	6.5%	20.8%	P=0.017*	14.3%	3.7 to 24.9	68.8	7.0 (4.0 to 27.0)

*P values are results of Fisher’s exact test.

ITT, intention-to-treat; NNTB, number needed to treat for benefit; NNTH, number needed to treat for harm; SSI, surgical site infection.