Randomised controlled trial of triclosan coated vs uncoated sutures in primary hip and knee arthroplasty

Table 1 Criteria and points allocation used in calculating the ASEPSIS score

ASEPSIS Score calculation
Points	Criterion
	Additional treatment
10	Antibiotics
5	Drainage of pus under local anaesthetic
10	Debridement of wound under general anaesthetic
0-5	Serous discharge
0-5	Erythema
0-10	Purulent exudate
0-10	Separation of deep tissues
10	Isolation of bacteria
5	Stay in hospital over 14 d
Breakdown of ASEPSIS score
0-10	No infection, normal healing
11-20	Disturbance of healing
21-30	Minor infection
31-40	Moderate infection
> 40	Severe infection

Table 2 Patient demographics between the two groups

		Trial group		P value
		Controls (n = 69)	Cases (n = 81)
Age	mean (SD)	67.85 (9.85)	68.65	0.44
			(10.90)
Diagnosis	OA	68	77	0.33
	SUFE	0	2
	AVN	1	0
	Hip dysplasia	0	1
	Perthes	0	1
Gender	Male	24	25	0.73
	Female	45	56
BMI	mean (SD)	28.70 (5.13)	29.14 (4.97)	0.54
Smoker	Yes	6	6	0.64
	Never	42	57
	Ex-smoker	13	12
Diabetic	Yes	4	10	0.26
	No	57	64
ASA Grade	1	9	9	0.68
	2	47	52
	3	13	20

OA: Osteoarthritis; SUFE: Slipped upper femoral epiphysis; AVN: Avascular necrosis; BMI: Body mass index; ASA: American Society of Anesthesiologist.

Table 3 Comparison of operative data between the two groups

		Trial group		P value
		Controls (n = 69)	Cases (n = 81)
Site	Hip	42	54	0.5
	Knee	27	27
Surgeon	Consultant	25	29	0.63
	Registrar	38	41
	Fellow	6	11
Anaesthetic	General	45	50	0.56
	Regional	17	26
	Both	3	2
Local anaesthetic	Yes	67	77	0.38
	No	1	4
Length of operation	mean (SD)	88.44 (23.84)	91.24 (26.5)	0.67
	mean (SD)	3.75 (0.87)	3.53 (0.81)	0.12
Number of sutures used	2	1	7	0.26
	3	23	29
	4	30	30
	5	6	8
	> 5	1	0
Prosthesis hip	Synergy – R3	37	48	0.30
	Trifit – Trinity	3	3
	Exeter	0	3
Knee	Triathalon	21	23	0.70
	Saiph knee	5	3
Wound closure (min)	mean (SD)	14.64 (5.51)	13.89 (5.13)	0.47
VAS score (mean, SD)	Day 1	6.47 (2.62)	6.20 (2.35)	0.34
	Day 3	4.75 (2.33)	4.18 (2.33)	0.15
	Day 5	4.67 (1.75)	2.92 (2.87)	0.18
Length of stay (d)	mean (SD)	6.13 (4.23)	6.23 (4.11)	0.95

VAS: Visual analogue scale.

Table 4 Outcomes at follow-up

		Trial group		P value
		Controls (n = 69)	Cases (n = 81)
ASEPSIS scores
0-10		65	75	0.75
> 10		4	6
mean (SD range)		1.41	2.54	0.036
		(0.38-2.43)	(1.41-3.68)
Follow-up outcomes (2-wk)
Site of follow-up	Hospital	35	37	0.21
	Community	27	28
	Inpatient	2	10
	Did not attend	5	6
Wound complications	Yes	1	6	0.22
	No	63	69
	Superficial SSI	1	2
	Erythema	0	3
	Serous discharge	0	1
Follow-up outcomes (6-wk)
Attended hospital	Yes	61	65	0.189
	No	8	16
Wound complications	Yes	1	8	0.03
	No	60	57
	Superficial SSI	1	3
	Wound dehiscence	0	1
	Irritation from suture	0	2
	Serous discharge	0	1
	Deep SSI	0	1
Systemic complications	Nausea and vomiting	0	2	0.12
	Dizziness	0	0	1.00
	Bleeding(not from wound)	1	2	0.26
	Stiffness	4	5	0.30
	Neurovascular injury	0	0	1.00
	DVT	1	0	0.18
	PE	0	1	0.19
	Chest infection	1	2	0.26
	MI	0	0	1.00
	CVA	0	0	1.00
	Fracture	0	2	0.12
	Dislocation	0	0	1.00
	Loosening	0	0	1.00
	Mortality	0	0	1.00
	Missing data	8	16

SSI: Surgical site infection.