Prophylactic antibiotics in open mesh repair of inguinal hernia - a randomized controlled trial. The role of antibiotic prophylaxis in elective tension-free mesh inguinal hernia repair: results of a single-centre prospective randomised trial. 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. The role of antibiotic prophylaxis on wound infection after mesh hernia repair under local anesthesia on an ambulatory basis. A randomized, double-blind, placebo-controlled trial to determine effectiveness of antibiotic prophylaxis for tension-free mesh herniorrhaphy. Local antibiotic prophylaxis in inguinal hernia repair. Effect of single-dose prophylactic ampicillin and sulbactam on wound infection after tension-free inguinal hernia repair with polypropylene mesh: the randomized, double-blind, prospective trial. The role of antibiotic prophylaxis in mesh repair of primary inguinal hernias using prolene hernia system: a randomized prospective double-blind control trial. Prospective randomized evaluation of prophylactic antibiotic usage in patients undergoing tension free inguinal hernioplasty. Antibiotic prophylaxis and open groin hernia repair. Predictive risk score for infection after inguinal hernia repair. [Infection prevention in elective large intestine surgery. Results of a prospective randomized comparative study]. Perioperative antibiotic prophylaxis for herniorrhaphy and breast surgery. Antibiotic prophylaxis for post-operative wound infection in clean elective breast surgery.
The role of prophylactic antibiotics in mesh repair of inguinal hernia is unclear. A Cochrane meta-analysis in 2005 concluded that "antibiotic prophylaxis for elective inguinal hernia repair cannot be firmly recommended or discarded" and "further studies are needed, particularly on the use for mesh repair." So, we designed a study to define the role of prophylactic antibiotics in mesh repair of inguinal hernia. We conducted a prospective, randomized, double-blind, trial comparing wound infection rates in 450 patients (225 received intravenous Cefazolin, 225 received a placebo) undergoing primary inguinal hernia repair electively using polypropylene mesh. 334 patients who completed a followup period of one month were analyzed. Age, American Society of Anesthesiologists class, type of hernia, type of anesthesia, grade of surgeon, pre and postoperative hospital stay and duration of operation were recorded. CDC criteria was used to define wound infection. Groups were well matched for all preoperative variables studied. The overall infection rate was 8.7% (29 out of 334). The incidence of wound infection in antibiotic group was 7% and 10.5% in control group. One from each group developed deep surgical site infection. Most of the infections occurred between the 7th and 12th post-operative day after discharge from the hospital. Antibiotic prophylaxis was associated with decreased incidence of wound infection when compared to control group, but the difference was not statistically significant. Based on our results we do not recommend the routine use of antibiotic prophylaxis in elective mesh repair of inguinal hernias.
                Copyright © 2010 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved. Hernia repair is one of the so-called clean operations. Many surgeons, however, use antibiotics, especially in the mesh repair era, without strong evidence to support this policy. We conducted a single-centre prospective randomised trial with a view to clarify this issue on a scientific basis. From January 2000 all patients undergoing elective inguinal hernia repair using a tension-free polypropylene mesh technique, provided they fulfilled predetermined criteria, were randomised to have a single dose of amoxicillin and clavoulanic acid or placebo in a double-blind manner. The main end point was to detect any difference in infectious complication rates - with specific interest to wound infection rates - between the two groups. Between January 2000 and June 2004, 386 patients entered the study (364 men and 22 women, median age 63 years, range 15-90 years) and were randomised to have antibiotic prophylaxis (group A, n = 193) or placebo (group B, n = 193). The two groups were comparable regarding demographic data. In total, 19 (5%) cases with infectious complications were detected. Fourteen of these were wound infections (3.7%). There were five cases of wound infection in group A and nine in group B (p = 0.4, Fisher's exact test). All wound infections were treated with antibiotics. The wound was opened in some cases. Mesh removal was not required in any of the cases. From the results of this study it does not appear that antibiotic prophylaxis offers any benefits in the elective mesh inguinal hernia repair. To determine whether the use of prophylactic antibiotics is effective in the prevention of postoperative wound infection after Lichtenstein open mesh inguinal hernia repair.
                A recent Cochrane meta-analysis (2003) concluded that "antibiotic prophylaxis for elective inguinal hernia repair cannot be firmly recommended or discarded."
                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.
                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.
                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. Mesh prosthesis, local anesthesia, and ambulatory care have been widely introduced in recent decades in the treatment of inguinal hernia. The use of antibiotic prophylaxis during open inguinal hernia repair has been controversial. No prospective trial has been conducted to assess the role of antibiotic prophylaxis in patients operated on for inguinal hernia under the above-mentioned conditions. A prospective, randomized, double-blinded trial was initiated to assess the efficacy of antibiotic prophylaxis in the prevention of wound infection during open mesh inguinal hernia repair under local anesthesia on an ambulatory basis. Ninety-nine consecutive hernia repairs were randomized to receive 1 g of parenteral Cefazolin preoperatively or a placebo. No wound infections existed in the therapeutic group (0/50). Four infections appeared in the control group (4/49), and the study was suspended for ethical reasons when differences reached values close to statistical significance ( P=0.059). We conclude that a single dose of intravenous Cefazolin decreases the risk of wound infection during open mesh inguinal hernia repair under local anesthesia on an ambulatory basis. In recent years, use of prosthetic material for inguinal hernia repair has increased dramatically. Tension-free repairs have gained popularity not only for recurrent or complicated hernias, but for primary hernia repairs as well. Although routine use of prophylactic antibiotics is not recommended in the Philippines for open nonimplant herniorrhaphy, there is little direct clinical evidence on which to base recommendations when implantable mesh is used.
                We conducted a prospective, randomized, double-blind, placebo-controlled trial comparing wound infection rates in 360 patients (180 received prophylactic antibiotics, 180 received a placebo) undergoing primary inguinal hernia repair electively using polypropylene mesh. Age, gender, American Society of Anesthesiologists class, type of hernia, type of anesthesia, and duration of operation were recorded. Infections were evaluated 1 week, 2 weeks, and 1 month after operation by an independent surgeon. All complications were recorded. Results were assessed using chi-square, Fisher's exact test, and Student's t-tests as appropriate.
                Groups were well matched for all preoperative variables studied, including comorbid conditions. Six patients from the antibiotic group and four from the placebo group failed to followup after the second week. Superficial surgical site infection developed in 3 patients (1.7%) from the antibiotic group and 6 (3.3%) from the placebo group (p = 0.50). One from each group developed deep surgical site infection. Both patients were readmitted and underwent repeated debridement, which eventually resulted in graft loss.
                Preoperative administration of single-dose antibiotic for tension-free inguinal mesh herniorrhaphy did not markedly decrease risk of wound infection in this patient population. Our results do not support use of antibiotic prophylaxis for tension-free mesh herniorrhaphy. We compared the effects of single dose (750 milligrams) prophylactic cefamandole delivered directly into the operative wound with local anesthesia (n = 162) with a control group (no antibiotics) (n = 162) in a randomized trial. No adverse effects were observed. There were seven wound abscesses in the untreated group compared with none in the group receiving antibiotic prophylaxis (p = 0.007). Six of the seven abscesses occurred as late as one month after the patient was discharged from the hospital. The costs of antibiotics used were ten times less than the costs of treatment of wound complications in the control group. To assess the value of single-dose, intravenous, prophylactic ampicillin and sulbactam (AS) in the prevention of wound infections during open prosthetic inguinal hernia repair by a double-blind, prospective, randomized trial.
                The use of antibiotic prophylaxis during open prosthetic inguinal hernia surgery is controversial, and no prospective trial has been conducted to examine this issue.
                Patients undergoing unilateral, primary inguinal hernia repair electively with the Lichtenstein technique using polypropylene mesh were randomized to receive 1.5 g intravenous AS before the incision or an equal volume of placebo according to a predetermined code of which the surgeons were unaware. Patients with recurrent, femoral, bilateral, giant, or incarcerated hernias or any systemic diseases were excluded. Age, sex, body mass index, American Society of Anesthesiologists score, type of hernia, type of anesthesia, duration of surgery, and use of drains were recorded. Infection was defined according to the criteria of Centers for Disease Control. Patients were evaluated 1 week, 1 month, 6 months, and 1 year after surgery by an independent surgeon. All complications were recorded. Results were assessed using chi-square, Fisher's exact, and Student t tests as appropriate.
                Between September 1996 and July 1998, 280 patients (140 AS, 140 placebo group) entered the protocol. Four patients from the AS group and seven from the placebo group were excluded because of inadvertent antibiotic administration or follow-up problems. Groups were well matched for all the variables studied and postoperative complications, excluding wound infections, which occurred at a rate of 0.7% in the AS group and 9% in the placebo group (P =.00153). Twelve patients in the placebo group developed wound infections, requiring five repeat hospital admissions in three patients. These three patients suffered deep infections reaching the graft, which resulted in graft loss in two. The single infected patient in the AS group had his graft removed as well because of deep persistent infection.
                This study documented a significant (10-fold) decrease in overall wound infections when single-dose, intravenous AS was used during Lichtenstein hernia repair. Deep infections and wound infection-related readmissions were also reduced by the use of AS. Proponents of mesh repairs may therefore be advised to use prophylactic single-dose intravenous antibiotic coverage in the light of the results of this trial. AS proved to be an effective antimicrobial agent. Antibiotic prophylaxis is being commonly used in mesh repair of inguinal hernia but its role has been questioned in a recent Cochrane analysis performed in 2003. Routine use of antibiotic prophylaxis in mesh repair of inguinal hernia can lead to bacterial resistance and increase in cost. In a present double-blind placebo controlled trial involving 120 patients undergoing inguinal hernia repair using prolene hernia system, we did not find any benefit of the routine use of antibiotic prophylaxis in terms of wound infection rate. Assessment of the usefulness of antibiotic prophylaxis in inguinal hernioplasty.
                This prospective randomized double blind study was conducted on 98 patients. Group A (50 patients) received a single dose of intravenous amoxicillin and clavulanic acid, and Group P (48 patients) received an equal volume of normal saline placebo by intravenous bolus 30 min before the induction of anesthesia. Hernioplasty was performed with polypropylene mesh. Skin was closed using skin staples that were removed after complete wound healing. The surgical site infection was diagnosed according to APIC, CDC criteria ( http://www.apic.org ).
                The mean operative time was 38.8  ± 10.8 min in group A versus 40.9 ± 11.1 min in group P (P  = 0.34). The mean hospitalization time was 1.3 ± 0.463 days in group A versus 1.25 ± 0.438 days in group P (P = 0.58). Four patients (2%) in group A and 6 patients (2.88%) in group P had wound infections (P = 0.47). Group A had 3 superficial infections and 1 deep infection while group P had 5 superficial infections and 1 deep infection. Antibiotic treatment of the wound infection was successful in all patients. Wound culture showed Staphylococcus aureus infection in 1 patient each group, Streptococcus pyogenes in 1 group A patient and Pseudomonas aeruginosa in 1 group P patient. Cultures in other patients in both groups were reported to be sterile.
                Prophylactic antibiotic usage in patients undergoing tension free inguinal hernioplasty did not show any statistically significant beneficial effects in reduction of surgical site infection. Antibiotic prophylaxis is not routinely given for nonimplant, clean operations, although this view has recently been challenged. We have conducted a randomized multicenter, double-blind prospective trial to compare co-amoxiclav with placebo in 619 patients undergoing open groin hernia repair. Altogether 563 (91%) patients fulfilled the protocol; 283 received co-amoxiclav and 280 placebo. There was no difference between the groups in the number of patients receiving local or general anesthetic, the type of repair performed, the use of a subcutaneous fat suture, the type of skin closure used, the use of wound analgesia, or the use of a wound drain. Patients were given a card to return to the hospital in the event of their wound discharging or their needing to see their general practitioner. All patients were reviewed at approximately 6 weeks after operation. Fifty (8.9%) patients sustained a wound infection, 25 in the co-amoxiclav group and 25 in the placebo group. We conclude that antibiotic prophylaxis is of no benefit to patients undergoing open groin hernia repair. Identification of subgroups of patients at high and low risk for global infectious complications (GIC) after inguinal hernia repair without mesh.
                A database of 1254 patients who underwent inguinal hernia repair without mesh, issued from 3 prospective multicenter randomized trials, has been established (group A). After multivariate analysis, a score for GIC was calculated and tested using data from a similar prospective randomized multicenter study (group B).
                A risk score for GIC was constructed: -4.7 + (0.95 x age > or =75 years) + (1.1 obesity) + (2.1 x urinary catheter). In case of score less than -4.2 (low-risk group), the GIC rate was 2.7%; therefore, in case of score more than -4.2 (high-risk score), the GIC rate was 14.3% (P < .001). In the low-risk group, the administration of antibiotic prophylaxis did not reduce the infectious complication rate, while in high-risk group the administration of antibiotic prophylaxis significantly reduced the rates of surgical site infection, GIC, and urinary infection by 72%, 67%, and 76.8%, respectively.
                This study demonstrates the efficacy of antibiotic prophylaxis in inguinal hernia surgery in the subgroup of high-risk patients. In a prospective randomized trial clinical results of orthograde bowel lavage alone (group I) versus combined bowel lavage and parenteral antibiotic prophylaxis with 4 gm Cefoxitin (group II) in two separate dosages (perioperative short-term-prophylaxis) are compared with regard to the reduction of septic complications after colorectal surgery. Septic wound complications were 11/27 = 41% in group I and 2/30 = 7% in group II. The rate of anastomotic leakages was significantly different in the two groups (5/27 in group I, 0 in group II). The monetary costs for given antibiotics and the duration of hospitalization were less in group II. Orthograde bowel lavage alone proved to be of no effect in reducing the rate of septic complications when used without antibiotic perioperative short-term-prophylaxis and therefore cannot be recommended to be used solely. We assessed the efficacy of perioperative antibiotic prophylaxis for surgery in a randomized, double-blind trial of 1218 patients undergoing herniorrhaphy or surgery involving the breast, including excision of a breast mass, mastectomy, reduction mammoplasty, and axillary-node dissection. The prophylactic regimen was a single dose of cefonicid (1 g intravenously) administered approximately half an hour before surgery. The patients were followed up for four to six weeks after surgery. Blinding was maintained until the last patient completed the follow-up and all diagnoses of infection had been made. The patients who received prophylaxis had 48 percent fewer probable or definite infections than those who did not (Mantel-Haenszel risk ratio, 0.52; 95 percent confidence interval, 0.32 to 0.84; P = 0.01). For patients undergoing a procedure involving the breast, infection occurred in 6.6 percent of the cefonicid recipients (20 of 303) and 12.2 percent of the placebo recipients (37 of 303); for those undergoing herniorrhaphy, infection occurred in 2.3 percent of the cefonicid recipients (7 of 301) and 4.2 percent of the placebo recipients (13 of 311). There were comparable reductions in the numbers of definite wound infections (Mantel-Haenszel risk ratio, 0.49), wounds that drained pus (risk ratio, 0.43), Staphylococcus aureus wound isolates (risk ratio, 0.49), and urinary tract infections (risk ratio, 0.40). There were also comparable reductions in the need for postoperative antibiotic therapy, non-routine visits to a physician for problems involving wound healing, incision and drainage procedures, and readmission because of problems with wound healing. We conclude that perioperative antibiotic prophylaxis with cefonicid is useful for herniorrhaphy and certain types of breast surgery. Antibiotic prophylaxis has been used to good effect in the prevention of post-operative wound infections in patients undergoing gastrointestinal operations. We have assessed the use of a single dose of intravenous antibiotic (Augmentin 1.2 g), given with induction of anaesthesia as prophylaxis, against post-operative wound infection in women undergoing clean, elective breast surgery. Three hundred and thirty-four patients were recruited. Of the 164 receiving antibiotic prophylaxis 29 (17.7%) had wound infections compared with 32 (18.8%) in the placebo group (P=0.79). There were no significant differences in any other post-operative infective complications. Antibiotic prophylaxis is probably not required in clean, elective breast surgery.
                Copyright 2000 Harcourt Publishers Ltd.
Based on the results of this systematic review the administration of antibiotic prophylaxis for elective inguinal hernia repair cannot be universally recommended. Neither can the administration be recommended against when high rates of wound infection are observed.