The role of antibiotic prophylaxis in prevention of wound infection after Lichtenstein open mesh repair of primary inguinal hernia: a multicenter double-blind randomized controlled trial.
OBJECTIVE
To determine whether the use of prophylactic antibiotics is effective in the prevention of postoperative wound infection after Lichtenstein open mesh inguinal hernia repair.


BACKGROUND
A recent Cochrane meta-analysis (2003) concluded that "antibiotic prophylaxis for elective inguinal hernia repair cannot be firmly recommended or discarded."


METHODS
Patients with a primary inguinal hernia scheduled for Lichtenstein repair were randomized to a preoperative single dose of 1.5 g intravenous cephalosporin or a placebo. Patients with recurrent hernias, immunosuppressive diseases, or allergies for the given antibiotic were excluded. Infection was defined using the Centers for Disease Control and Prevention criteria.


RESULTS
We included 1040 patients in the study between November 1998 and May 2003. According to the intention-to-treat principle, 1008 patients were analyzed. There were 8 infections (1.6%) in the antibiotic prophylaxis group and 9 (1.8%) in the placebo group (P = 0.82). There was 1 deep infection in the antibiotic prophylaxis group and 2 in the placebo group (P = 0.57). Statistical analysis showed an absolute risk reduction of 0.19% (95% confidence interval, -1.78%-1.40%) and a number needed to treat of 520 for the total number of infections. For deep infection, the absolute risk reduction is 0.20% (95% confidence interval, -0.87%-0.48%) with a number needed to treat of 508.


CONCLUSIONS
A low percentage (1.7%) of wound infection after Lichtenstein open mesh inguinal (primary) hernia repair was found, and there was no difference between the antibiotic prophylaxis or placebo group. The results show that, in Lichtenstein inguinal primary hernia repair, antibiotic prophylaxis is not indicated in low-risk patients.
Aufenacker
Theo J
TJ
Department of Surgery, Onze Lieve Vrouwe Gasthuis, Eerste Oosterparkstraat 279, 1091 HA Amsterdam, The Netherlands.
van Geldere
Dirk
D
van Mesdag
Taco
T
Bossers
Astrid N
AN
Dekker
Benno
B
Scheijde
Edo
E
van Nieuwenhuizen
Roos
R
Hiemstra
Esther
E
Maduro
John H
JH
Juttmann
Jan-Willem
JW
Hofstede
Diederik
D
van Der Linden
Cunera T M
CT
Gouma
Dirk J
DJ
Simons
Maarten P
MP
D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D019072:Antibiotic Prophylaxis; D002444:Cefuroxime / Q000627:therapeutic use*; D013505:Digestive System Surgical Procedures / Q000379:methods; D004311:Double-Blind Method; D005260:Female; D006552:Hernia, Inguinal / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D013526:Surgical Mesh; D013530:Surgical Wound Infection / Q000517:prevention & control*
D000900:Anti-Bacterial Agents; D002444:Cefuroxime