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Table 1 Baseline demographic, clinical and operation characteristics

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

 

Staples group (control group) n = 173

Subcuticular group (experimental group) n = 173

Age (years)

63.92 (12.61)

62.17 (14.41)

Sex

  

 Female

86 (49.71%)

66 (38.15%)

 Male

87 (50.29%)

107 (61.85%)

BMI (Kg/m2)

27.87 (5.45)

28.01 (5.55)

ASA score

  

 I–II

94 (54.33%)

95 (54.91%)

 III–IV

79 (45.66%)

78 (48.09%)

Comorbidities

  

 Active smoker

33 (19.07%)

30 (17.34%)

 Alcohol abuse

24 (13.87%)

29 (16.76%)

 Diabetes mellitus

34 (19.65%)

34 (19.65%)

 COPD

26 (15.03%)

27 (15.61%)

 Chronic liver disease/liver

15 (8.67%)

18 (10.4%)

Cirrhosisa

  

 Biliary drainage

8 (4.62%)

9 (5.20%)

 Chronic kidney disease

11 (6.35%)

14 (8.09%)

 Cardiopathies

82 (47.39%)

76 (43.93%)

Baseline diagnosis

  

 Benign

92 (53.17%)

92 (53.17%)

 Malignant or borderline

81 (46.82%)

81 (46.82%)

Serum biochemical parameters

  

 Albumin (g/dL)

4.24 (0.46)

4.18 (0.42)

 Total proteins (g/dL)

7 (0.52)

6.91 (0.52)

 GOT (mg/dL)

21 (17–28)

22 (18–32)

 GGT (mg/dL)

39 (24–88)

43 (16–112)

 Total bilirubin (mg/dL)

0.5 (0.3–0.8)

0.5 (0.4–0.8)

 Hemoglobin (g/dL)

13.63 (1.41)

13.67 (1.61)

Type of surgery

  

 Open

79 (45.66%)

84 (48.55%)

 Laparoscopy

94 (54.33%)

89 (51.44%)

Surgical procedure

  

 Cholecystectomy

87 (50.29%)

86 (49.71%)

 Pancreatic resection

26 (15.03%)

32 (18.50%)

 Major hepatic resection

14 (8.09%)

13 (7.51%)

 Minor hepatic resection

24 (13.87%)

19 (10.98%)

 Bilioenteric reconstruction

4 (2.31%)

3 (1.73%)

 Oncologic bile duct resection (i.e. cholangiocarcinoma)

4 (2.31%)

5 (2.89%)

 Othersb

14 (8.09%)

15 (8.67%)

Intraoperative blood loss (mL)

109.61 (95.78)

116.46 (96.18)

Prophylactic antibiotic therapy

173 (100%)

173 (100%)

Wound contamination class (Class 1, 2 or 3)c

11 (6.35%)/155 (89.6%)/7 (4.05%)

13 (7.5%)/151 (87.3%)/9 (5.20%)

Surgery time (min)

148.2 (89.4)

155.4 (95.4)

Lowest body temperature (oC)

35.8 (32.1–37.4)

35.7 (32.0–37.1)

  1. aChronic liver disease/liver cirrhosis patients included only Child–Pugh scale “A” class patients: Child–Pugh A5 (staples group, 13; subcuticular group, 15) and A6 (staples group, 2; subcuticular group 3)
  2. bOther surgical procedures included: laparotomy exploration and biopsy due to irresectable tumour (staples, 10; subcuticular, 9), splenectomy (staples, 1; subcuticular, 3), transduodenal ampulectomy (staples, 2; subcuticular, 2) and partial pericystectomy (staples, 1; subcuticular, 1)
  3. cWound contamination class according to CDC criteria [13]