Subcuticular suture and incisional surgical-site infection in elective hepatobiliary and pancreatic surgery: an open-label, pragmatic randomized clinical trial (CLOSKIN trial)

Table 2 Primary endpoint and subsequent subgroups analysis results

	Staples group	Subcuticular suture group	p-value
30-day si-SSI rate	ITT: 17/173 (9.83%) PP: 17/167 (10.18%)	ITT: 8/173 (4.62%) PP: 8/168 (4.76%)	p = 0.062 p = 0.059
Subset analysis results (ITT analysis)
• Cholecystectomy procedure^a	6/87 (6.89%)	3/87 (3.45%)	p = 0.061
• Major open surgery^b	12/79 (15.20%)	5/84 (5.95%)	p = 0.054
• Major liver surgery	5/38 (13.16%)	2/32 (6.25%)	p = 0.342
• Major pancreatic surgery	5/26 (19.23%)	1/32 (3.13%)	p = 0.08
• Bilioenteric reconstruction	1/8 (12.50%)	1/8 (12.50%)	p = 0.767
• Laparoscopic approach	7/93 (7.63%)	5/88 (5.68%)	p = 0.178

^aCholecystectomy surgery subgroup included patients undergoing elective either laparoscopic or open cholecystectomy. Laparoscopic was the preferred approach. Reasons for open approach were conversion from laparoscopy due to intraoperative findings or complications and upfront indication considering patient baseline comorbidities or previous surgeries. Most procedures were performed laparoscopic: overall 161 (92.53%) laparoscopic cholecystectomy, staples group 82 (94.23%) and subcuticular suture group (90.85%)
^bMajor open surgery included all performed open abdominal HBP surgeries excluding simple cholecystectomy, both laparoscopic and open. Cholecystectomy was a less aggressive or invasive procedure when compared to other performed surgeries and thus was analyzed in a different subgroup

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