Antibiotic prophylaxis for prevention of postoperative wound infection in adults undergoing open elective inguinal or femoral hernia repair

Claudia C Orelio; Coen van Hessen; Francisco Javier Sanchez-Manuel; Theodorus J Aufenacker; Rob JPM Scholten

doi:10.1002/14651858.CD003769.pub5

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 3

Forest plot of comparison antibiotic prophylaxis against placebo for preventing all types of wound infection (SSSI and DSSI) after herniorrhaphy surgery.

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Figure 4

Forest plot of comparison antibiotic prophylaxis against placebo for preventing all types of wound infection (SSSI and DSSI) after hernioplasty surgery.

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Figure 5

Forest plot of comparison antibiotic prophylaxis against placebo for preventing superficial wound infection (SSSI) after hernioplasty surgery.

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Figure 6

Forest plot of comparison antibiotic prophylaxis against placebo for preventing deep wound infections (DSSI) after hernioplasty surgery.

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Analysis 1.1

Comparison 1: Wound infections herniorrhaphy, Outcome 1: All wound infections (SSSI+DSSI)

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Analysis 2.1

Comparison 2: Wound infections hernioplasty, Outcome 1: All wound infections (SSSI+DSSI)

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Analysis 2.2

Comparison 2: Wound infections hernioplasty, Outcome 2: Superficial Surgical Site Infections (SSSI)

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Analysis 2.3

Comparison 2: Wound infections hernioplasty, Outcome 3: Deep Surgical Site Infections (DSSI)

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Summary of findings 1. Antibiotic prophylaxis compared to placebo for prevention of postoperative wound infection in adults undergoing open inguinal or femoral herniorrhaphy surgery

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Antibiotic prophylaxis compared to placebo for prevention of postoperative wound infection in adults undergoing open elective inguinal or femoral herniorrhaphy hernia repair
Patient or population: prevention of postoperative wound infection in adults undergoing open elective inguinal or femoral herniorrhaphy hernia repair Setting: Intervention: antibiotic prophylaxis Comparison: placebo
Outcomes	Risk with placebo	Risk with antibiotic prophylaxis	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
All wound infections (SSSI + DSSI)	Study population		RR 0.86 (0.56 to 1.33)	1865 (5 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}
All wound infections (SSSI + DSSI)	49 per 1000	42 per 1000 (27 to 65)	RR 0.86 (0.56 to 1.33)	1865 (5 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2}
All wound infections (SSSI + DSSI) ‐ low infection risk environment	Study population		RR 0.63 (0.28 to 1.41)	1302 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{2 3}
	32 per 1000	20 per 1000 (9 to 45)	RR 0.63 (0.28 to 1.41)	1302 (4 RCTs)	⊕⊝⊝⊝ VERY LOW ^{2 3}
All wound infections (SSSI + DSSI) ‐ high infection risk environment	Study population		RR 0.99 (0.58 to 1.68)	563 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 4}
	89 per 1000	88 per 1000 (52 to 150)	RR 0.99 (0.58 to 1.68)	563 (1 RCT)	⊕⊝⊝⊝ VERY LOW ^{2 4}
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ 3 of 5 studies had high risk of bias for outcome or attrition bias. ² The confidence interval of the pooled effect size estimate includes both benefit and harm. Also, the optimal information size was not reached and sample size was small. Downgrade −2 ³ All studies have unclear or high risk of bias for selection bias, detection bias or attrition bias ⁴ The risk of bias for selection bias and detection bias is unclear and attrition bias is high for this study

Summary of findings 1. Antibiotic prophylaxis compared to placebo for prevention of postoperative wound infection in adults undergoing open inguinal or femoral herniorrhaphy surgery

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Summary of findings 2. Antibiotic prophylaxis compared to placebo for prevention of postoperative wound infection in adults undergoing open inguinal or femoral hernioplasty surgery

Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
Antibiotic prophylaxis compared to placebo for prevention of postoperative wound infection in adults undergoing open elective inguinal or femoral hernioplasty hernia repair
Patient or population: prevention of postoperative wound infection in adults undergoing open elective inguinal or femoral hernioplasty hernia repair Setting: Intervention: antibiotic prophylaxis Comparison: placebo
Outcomes	Risk with placebo	Risk with antibiotic prophylaxis	Relative effect (95% CI)	№ of participants (studies)	Certainty of the evidence (GRADE)	Comments
All wound infections (SSSI + DSSI)	Study population		RR 0.61 (0.48 to 0.78)	6443 (22 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2 3 4}
All wound infections (SSSI + DSSI)	55 per 1000	33 per 1000 (26 to 43)	RR 0.61 (0.48 to 0.78)	6443 (22 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2 3 4}
All wound infections (SSSI + DSSI) ‐ low infection risk environment	Study population		RR 0.71 (0.44 to 1.14)	3100 (9 RCTs)	⊕⊕⊕⊝ MODERATE ^{2 3 5 6}
	26 per 1000	18 per 1000 (11 to 30)	RR 0.71 (0.44 to 1.14)	3100 (9 RCTs)	⊕⊕⊕⊝ MODERATE ^{2 3 5 6}
All wound infections (SSSI + DSSI) ‐ high infection risk environment	Study population		RR 0.58 (0.43 to 0.77)	3343 (13 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 6 7}
	85 per 1000	49 per 1000 (37 to 65)	RR 0.58 (0.43 to 0.77)	3343 (13 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 6 7}
SSSI	Study population		RR 0.60 (0.46 to 0.78)	6263 (21 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2 3 4}
SSSI	50 per 1000	30 per 1000 (23 to 39)	RR 0.60 (0.46 to 0.78)	6263 (21 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2 3 4}
SSSI ‐ low infection risk environment	Study population		RR 0.71 (0.44 to 1.17)	3100 (9 RCTs)	⊕⊕⊕⊝ MODERATE ^{2 3 5 6}
SSSI ‐ low infection risk environment	24 per 1000	17 per 1000 (11 to 28)	RR 0.71 (0.44 to 1.17)	3100 (9 RCTs)	⊕⊕⊕⊝ MODERATE ^{2 3 5 6}
SSSI ‐ high infection risk environment	Study population		RR 0.56 (0.41 to 0.77)	3163 (12 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 6 7}
SSSI ‐ high infection risk environment	79 per 1000	44 per 1000 (32 to 61)	RR 0.56 (0.41 to 0.77)	3163 (12 RCTs)	⊕⊝⊝⊝ VERY LOW ^{1 2 3 6 7}
DSSI	Study population		RR 0.65 (0.26 to 1.65)	4185 (12 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2 3 4}
DSSI	6 per 1000	4 per 1000 (2 to 10)	RR 0.65 (0.26 to 1.65)	4185 (12 RCTs)	⊕⊕⊕⊝ MODERATE ^{1 2 3 4}
DSSI ‐ low infection risk environment	Study population		RR 0.67 (0.11 to 4.13)	1488 (3 RCTs)	⊕⊕⊕⊝ MODERATE ^{2 3 5 6}
DSSI ‐ low infection risk environment	4 per 1000	3 per 1000 (0 to 17)	RR 0.67 (0.11 to 4.13)	1488 (3 RCTs)	⊕⊕⊕⊝ MODERATE ^{2 3 5 6}
DSSI ‐ high infection risk environment	Study population		RR 0.64 (0.22 to 1.89)	2697 (9 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 3 6}
DSSI ‐ high infection risk environment	7 per 1000	4 per 1000 (2 to 13)	RR 0.64 (0.22 to 1.89)	2697 (9 RCTs)	⊕⊕⊝⊝ LOW ^{1 2 3 6}
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Excluding the studies with unclear and/or high risk of bias from the meta‐analysis affects the summary RR. Downgrade −1. ² Chi² test P > 0.05, I² < 60%, all confidence intervals of pooled effect estimates overlap. Clinical heterogeneity is limited as in similar patients are included, although different types and doses of antibiotics were applied. Evidence was not downgraded for clinical heterogeneity. ³ There are no indirect comparisons or surrogate outcomes used in the studies ⁴ The confidence interval of the pooled effect size includes both benefit and harm. Optimal information size was not reached, but evidence was not downgraded as the sample size is large. ⁵ Excluding the studies with unclear or high risk of bias hardly affects the summary RR, therefore not downgraded. ⁶ The confidence interval of the pooled effect size includes both benefit and harm. Optimal information size was not reached and sample size is small, therefore downgrade −1. ⁷ Asymmetrical forest plot reveals a under representation of studies that favour the control treatment.

Summary of findings 2. Antibiotic prophylaxis compared to placebo for prevention of postoperative wound infection in adults undergoing open inguinal or femoral hernioplasty surgery

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Table 1. Overview of treatment characteristics of the included herniorrhaphy studies

	Antibiotic	Dose (g)	Administration route	Follow‐up period	Operative time (minutes); (mean ± SD or median (range))	Infection risk environment (Infection percentage in control group)	Remark
Andersen 1980	AMP	1	in fascia	1 m, 3 m, 6 m, 12 m	not reported	Low (4.0%)	Several surgery types performed
Evans 1973	CLR	1 (3×)	intravenous (1x)/ intramuscular (2x)	1 m	not reported	Low (4.1%)	Several surgery types performed
Lazorthes 1992	CAM	0.75	subcutaneous (added to local anaesthesia)	1 m	not reported	Low (4.6%)
Platt 1990	CON	1	intravenous	1 w, 4 to 6 w	PG: 75 ± 32 / CG: 75 ± 30	Low (1.9%)	Several surgery types performed
Taylor 1997	AMC	1.2	intravenous	4 to 6 w	not reported	High (8.9%)
PG = prophylactic group, CG = control group AMC = Amoxicillin‐clavoulanic acid, AMP = ampicillin, CAM = cefamandole, CON = cefonicid, CLR = cephaloridine (Abbreviations according to EUCAST System for Antimicrobial Abbreviations) w = week, m = month, y = year Infection risk environment (L = low; ≤ 5% infections in control group for all wound infections (SSSI + DSSI), H = high; > 5% infections in control group for all wound infections (SSSI + DSSI) ).

Table 1. Overview of treatment characteristics of the included herniorrhaphy studies

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Table 2. Overview of treatment characteristics of the included hernioplasty studies

	Antibiotic	Dose (g)	Administration route	Follow‐up period	Operative time (minutes); (mean ± SD or median (range))	Infection risk environment (Infection percentage in control group)
Al‐Fatah 2011	AMC	1.2	intravenous	1 w/1 m	PG: 45 (20 to 90); CG:45 (20 to 80)	High (5.0%)
Aufenacker 2004	CUR	1.5	intravenous	1 w, 2 w, 3 m	PG: 40 (IQR 30 to 50); CG 40 (IQR 28 to 51)	Low (1.8%)
Bidhur 2013	CUR	1.5	intravenous	1 w, 1 m	51.3 ± 9.8 (range 40 to 75 min) (overall population) /Time<50 min: PG: n = 19 (63%); CG: n = 15 (50%)	Low (3.3%)
Celdran 2004	CZO	1	not reported	1 w, 1 m, 3 m, 6 m, 1 y, 2 y	PG: 65 ± 23; CG: 64 ± 14	High (8.2%)
Ergul 2011	CZO	1	intravenous	1 to 6 d, 1 m	PG: 60 (35 to 160); CG: 60 (40 to 135)	High (7.0%)
Goyal 2011	AMC	1.2	intravenous	1 w	not reported	Low (3.0%)
Ijaz 2010	CZO	1	intravenous	1 w, 2 w, 1 m	not reported	High (10.0%)
Jain 2008	AMC	1.2	intravenous	1 w, 2 w, 1 m, 1 y	PG: 56.33 ± 11.67; CG: 60.33 ± 6.81	Low (1.7%)
Kochhar 2014	AMC	1.2	intravenous	1 w, 1 m	not reported	Low (4.7%)
Mazaki 2013	CZO	1	intravenous	1 w, 1 m, 3 m	PG: 66.3 ± 25.4; CG: 65.2 ± 27.1	High (13.0%)
Morales 2000	CZO (or ERY)	2 (or 1)	intravenous	1 w, 1 m, 1 y	not reported	Low (2.1%)
Oteiza 2004	AMC	2	intravenous	1 w, 1 m	PG and CG: Mean 40 min	Low (0%)
Othman 2011	AMC	1.2	intravenous	1 w, 1 m	PG 38.8 ± 10.8; CG 40.9 ± 11.1	High (12,5%)
Perez 2005	CZO	1	intravenous	1 w, 2 w, 1 m	PG 52.18 ± 16.4; CG 54.07 ± 15.3	Low (3.9%)
Rahmani 2012	CLT	1	intravenous	12 w	not reported	High (6.4%)
Razack 2015	CZO	1	intravenous	1 w, 1 m	PG: 53.54 ± 15.82; CG 52.60 ± 15.28	High (9.3%)
Shankar 2010	CZO	1	intravenous	1 w, 1 m	PG 53.54 ± 15.82; CG 52.60 ± 15.28	High (10.5%)
Thakur 2010	CZO	1.5	intravenous	1w,1m	PG: 79.3% (n = 23) had the total duration of surgery > 1 hour; CG: 92.3% (n = 24) had the total duration of surgery > 1 hour.	High (15.4%)
Tzovaras 2007	AML	1.2	intravenous	1 w, 1 m	PG: 45 (20 to 90); CG: 45 (20 to 80)	Low (4.8%)
Ullah 2013	AMC	1	not reported	2 d, 2 w	not reported	High (18.1%)
Wang 2013	CZO or LEV	1 or 0.2	intravenous	1 w, 2 w, 3 w, 1 m	not reported	High (5.1%)
Yerdel 2001	AMS	1.5	intravenous	1 w, 4 to 6 w, 6 m, 1 y	PG: 64.18 ± 22.8; CG: 62.78 ± 19.3	High (9.0%)
PG = prophylactic group, CG = control group AMC = Amoxicillin‐clavoulanic acid, AML = ampicillin‐clavulanic acid, AMS = ampicillin‐sulbactam, CLT = cephalotin, CUR = cefuroxime, CZO = cefazolin, ERY = erythromycin, LEV = Levofloxacin (Abbreviations according to EUCAST System for Antimicrobial Abbreviations) w = week, m = month, y = year Infection risk environment (L = low; ≤ 5% infections in control group for all wound infections (SSSI + DSSI), H = high; > 5% infections in control group for all wound infections (SSSI + DSSI) ).

Table 2. Overview of treatment characteristics of the included hernioplasty studies

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Table 3. Overview of participant characteristics of the included herniorrhaphy studies

	% male	Age (years) in mean ± SD or median (range)	Participants age < 18 y included	Inguinal (I) or femoral (F) hernia	ASA class	BMI mean ± SD or median (range)
Andersen 1980	PG: 72; CG:73	PG: 54 to 56 years (range 21 to 82); CG: 55 years (range 20 to 82)	No	I + F	Not reported	Not reported
Evans 1973	not reported	not reported	not reported	I + F	Not reported	Not reported
Lazorthes 1992	PG: 90; CG: 88	PG: 62 (11 to 90)/ CG: 70 (16 to 92)	Yes	I + F	Not reported	Not reported
Platt 1990	PG: 91; CG: 89	PG: 51.0 ± 17.0/ CG: 49.8 ± 17.6	No	I + F	Not reported	PG 24.6 ± 3.2; CG 24.7 ± 3.2
Taylor 1997	PG: 95; CG: 95	PG: 56.7 ± 17.4 / CG: 56.6 ± 16.5	No	I + F	Not reported	Not reported
PG = prophylactic group, CG = control group

Table 3. Overview of participant characteristics of the included herniorrhaphy studies

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Table 4. Overview of participant characteristics of the included hernioplasty studies

	% male	Age (years) in mean ± SD or median (range)	Participants age < 18 y included	Inguinal (I) or femoral (F) hernia	ASA class	BMI mean ± SD or median (range)
Al‐Fatah 2011	PG: 94; CG: 96	PG: 63 (17 to 87); CG: 63 (15 to 90)	Yes	I	I; II; III	PG: 26 (18 to 34); CG: 26 (20 to 33)
Aufenacker 2004	PG: 96; CG: 97	PG: 58.3 ± 12.9; CG: 58.2 ± 13.2	No	I	Not reported	Not reported
Bidhur 2013	PG: 100; CG: 97	38.5 ± 17.7 (range: 19 to 90 years) (overall study population)	No	I	Not reported	Not reported
Celdran 2004	PG: 94; CG: 86	PG: 58 ± 13; CG: 58 ± 17	No	I	I; II	PG: 26.1 ± 5/ CG: 26.2 ± 5
Ergul 2011	PG: 95; CG: 89	PG: 48 ± 17; CG: 50 ± 15	No	I	I; II; III; IV	Not reported
Goyal 2011	NR	range 11 to 90 (overall study population)	Yes	I	Not reported	Not reported
Ijaz 2010	99 (overall)	PG: 44.06; CG: 44.84	No	I	Not reported	Not reported
Jain 2008	PG: 100; CG:100	PG: 41.28 ± 11.49; CG: 40.2 ± 9.84	No	I	I/ II	Not reported
Kochhar 2014	96 (overall)	PG: 37.42 ± 9.9; CG: 37.42 ± 11.5	Yes	I	Not reported	Not reported
Mazaki 2013	PG: 89/ CG: 94	PG: 69 (57 to 76); CG: 72 (60 to 77)	No	I	I; II; III	PG: 23.0 ± 2.8 PG; CG: 22.7 ± 3.0
Morales 2000	89 (overall)	54.2 (17 to 87) (overall study population)	No	I+F	I; II; III	Not reported
Oteiza 2004	PG: 89; CG: 82	PG: 58 (22 to 91)/ CG: 56.2 (17 to 88)	Yes	I+F	I; II; III	Not reported
Othman 2011	PG: 96; CG: 100	PG: 43.4 ± 19.8/ CG: 44.5 ± 20.5	No	I	Not reported	Not reported
Perez 2005	PG: 98; CG: 98	PG: 61.37 ± 13.2/ CG: 60.8 ± 14.5	No	I	I; II	Not reported
Rahmani 2012	PG: 45; CG: 41	25 to 84 (overall population)	No	I	not reported	Not reported
Razack 2015	PG: 99; CG: 100	PG: 42.44 ± 15.61 / CG: 45.56 ± 15.43	Yes	I	I; II	Not reported
Shankar 2010	PG: 99; CG: 98	PG: 44.44 ± 15.59 / CG: 45.56 ± 16.43	Yes	I	I; II	Not reported
Thakur 2010	PG: 100; CG: 100	Not reported	No	I	Not reported	Not reported
Tzovaras 2007	PG: 94; CG: 94	PG: 63 (17 to 87) / CG: 63 (15 to 90)	Yes	I	I; II; III	PG: 26 (18 to 34); CG: 26 (20 to 33)
Ullah 2013	PG: 100; CG: 100	PG: 54.33 ± 11.77 / CG: 52.58 ± 11.80	No	I	Not reported	Not reported
Wang 2013	PG group 1: 90; PG group 2: 91; CG: 90	PG group 1: 53 ± 16.9; PG group 2: 54.6 ± 16.2/ CG: 56 ± 17.3	Yes	I	I, ≥ I	18 to 32 (overall)
Yerdel 2001	PG: 90; CG: 95	PG: 55.57 ± 15.1; CG: 55.78 ± 13.8	No	I	I; II	PG: 24.95 ± 2.6; CG: 25.02 ± 3.0
PG = prophylactic group, CG = control group

Table 4. Overview of participant characteristics of the included hernioplasty studies

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Comparison 1. Wound infections herniorrhaphy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 All wound infections (SSSI+DSSI) Show forest plot	5	1865	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.56, 1.33]

1.1.1 Low infection risk environment	4	1302	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.28, 1.41]
1.1.2 High infection risk environment	1	563	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.58, 1.68]

Comparison 1. Wound infections herniorrhaphy

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Comparison 2. Wound infections hernioplasty

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
2.1 All wound infections (SSSI+DSSI) Show forest plot	22	6443	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.48, 0.78]

2.1.1 low infection risk environment	9	3100	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.44, 1.14]
2.1.2 high infection risk environment	13	3343	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.43, 0.77]
2.2 Superficial Surgical Site Infections (SSSI) Show forest plot	21	6263	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.46, 0.78]

2.2.1 low infection risk environment	9	3100	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.44, 1.17]
2.2.2 high infection risk environment	12	3163	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.41, 0.77]
2.3 Deep Surgical Site Infections (DSSI) Show forest plot	12	4185	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.26, 1.65]

2.3.1 low infection risk environment	3	1488	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.11, 4.13]
2.3.2 high infection risk environment	9	2697	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.22, 1.89]

Comparison 2. Wound infections hernioplasty

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