Surgical site infections (SSIs) remain a common and significant postoperative complication, affecting approximately 0.5% to 3% of patients undergoing surgery and representing one of the leading causes of healthcare-associated infections worldwide.[1-5] SSIs can prolong hospitalization, increase healthcare costs, and contribute to patient morbidity, especially in procedures involving prosthetic materials such as mesh hernioplasty, where infection may require mesh removal, leading to chronic complications and hernia recurrence. The prophylactic use of antibiotics has been widely adopted to reduce the incidence of SSIs in clean and clean-contaminated surgeries. [6,7] Traditionally, intravenous (IV) antibiotic prophylaxis has been the standard practice, with systemic distribution providing generalized antimicrobial coverage. However, systemic administration can result in suboptimal antibiotic concentrations at the surgical wound site due to tissue perfusion variability, potentially compromising local infection control. [8] Intra-incisional antibiotic infiltration, which delivers antibiotics directly into the surgical wound before closure, has emerged as a promising alternative approach. This method achieves high local antibiotic concentrations precisely where bacterial contamination is most likely to occur, potentially enhancing bactericidal activity while minimizing systemic exposure and adverse effects. [9,10] Additionally, in the context of rising antimicrobial resistance, optimizing antibiotic use by targeting administration to the surgical site may reduce the need for prolonged systemic therapy and help curb the development of resistant strains. Although several studies have suggested that intra-incisional prophylaxis may reduce SSI rates in various surgical settings, evidence comparing its efficacy directly with conventional IV administration in open inguinal hernia repair (OIHR) remains limited. The aim of this prospective comparative study was conducted to evaluate and compare the incidence of SSIs in patients undergoing uncomplicated OIHR using prophylactic antibiotics administered either intravenously or via intra-incisional infiltration.

The prospective, interventional comparative study was conducted over two years in the Department of Surgery at Dr. D.Y. Patil Medical College, Hospital and Research Institute, Kolhapur. A total of 66 patients with uncomplicated inguinal hernia, scheduled for Lichtenstein tension-free mesh repair, were enrolled after meeting inclusion criteria, which required patients to be over 18 years of age and willing to provide informed consent. Patients were excluded if they had allergies to cefotaxime, were on prolonged steroid therapy, had uncontrolled diabetes, were immunocompromised, presented with obstructed hernias, underwent laparoscopic repairs, or declined participation. Written informed consent was obtained in both English and the local language (Marathi) as approved by the Institutional Ethics Committee. Patients underwent thorough clinical evaluation and routine preoperative investigations prior to surgery. Using simple randomization, participants were allocated into two groups: Group A (n=33), which received conventional IV prophylaxis with cefotaxime 1 g administered one hour before the skin incision followed by postoperative cefotaxime (1 g twice daily) for five days; and Group B (n=33), which received intra-incisional prophylaxis consisting of 1 g cefotaxime diluted in 10 ml of distilled water, injected intradermally and subdermally along the wound edges at 1 cm intervals before closure, with no postoperative antibiotics administered. All surgeries were performed under standardized operative conditions. The surgical wound was inspected on postoperative days 2, 4, and 7 for signs of SSI, and patients were followed until postoperative day 7. The need for additional antibiotics, duration of hospital stay, readmissions, and postoperative complications were documented for both groups. Data were recorded in a predesigned proforma and entered into a master chart using MS Excel. Descriptive statistics were calculated, and data were analyzed using appropriate statistical tests, including the unpaired t-test for continuous variables. Categorical data were compared using chi-square or Fisher’s exact tests where applicable. A p-value <0.05 was considered statistically significant.

Table 1. Baseline demographic and clinical characteristics Characteristic Group A (n=33) Group B (n=33) p-value Mean age (years ± SD) 46.66 ± 12.99 49.03 ± 15.47 0.5028 Sex (Male/Female) 32/1 31/2 0.5621 Mean BMI (kg/m² ± SD) 25.88 ± 0.52 25.90 ± 0.55 0.8798 Unilateral hernia (%) 63.64% 66.67% 0.7977 Bilateral hernia (%) 36.36% 33.33% A total of 66 patients undergoing uncomplicated open inguinal hernioplasty were enrolled, with 33 randomized to each group. Baseline demographic and clinical characteristics, including age, sex, BMI, and type of hernia, were comparable between Group A (IV antibiotics) and Group B (intra-incisional antibiotics), ensuring minimal confounding. Table 2. Incidence of surgical site infection at postoperative days 2, 4, and 7 Time point Group A n (%) Group B n (%) p-value Day 2 SSI 3 (9.09%) 2 (6.06%) 0.6444 Day 4 SSI 3 (9.09%) 1 (3.03%) 0.3059 Day 7 SSI 3 (9.09%) 0 (0%) 0.0785 The primary outcome—incidence of surgical site infection (SSI)—was assessed on postoperative days 2, 4, and 7. On day 2, 3 patients (9.09%) in Group A and 2 patients (6.06%) in Group B developed SSIs (p=0.6444). By day 4, infections persisted in 3 patients (9.09%) in Group A but decreased to 1 patient (3.03%) in Group B (p=0.3059). On day 7, 3 patients (9.09%) in Group A continued to have SSIs, while no patients (0%) in Group B had infections (p=0.0785), suggesting a trend toward lower infection rates with intra-incisional prophylaxis, though without statistical significance. Table 3. Secondary outcomes Outcome Group A n (%) or Mean ± SD Group B n (%) or Mean ± SD p-value Additional antibiotics required 3 (9.09%) 2 (6.06%) 0.6444 Duration of hospital stay (days) 5.66 ± 0.73 5.6 ± 0.96 0.7760 Readmission 1 (3.03%) 1 (3.03%) 1.0000 Uneventful recovery 32 (96.97%) 31 (93.94%) 0.5576 Regarding secondary outcomes, the requirement for additional antibiotics due to clinical suspicion or confirmation of SSI was similar between groups (9.09% in Group A vs. 6.06% in Group B; p=0.6444). The mean duration of hospital stay did not differ significantly (5.66 ± 0.73 days in Group A vs. 5.6 ± 0.96 days in Group B; p=0.7760). Readmission occurred in one patient (3.03%) in each group (p=1.0000). Overall outcomes were favorable, with most patients experiencing uneventful recoveries (96.97% in Group A and 93.94% in Group B; p=0.5576) These results indicate that both prophylactic strategies were effective and safe, but intra-incisional antibiotic administration showed a clinically meaningful trend toward reduced SSIs, particularly by day 7, supporting its potential role as a targeted alternative to systemic prophylaxis.

Surgical site infection (SSI) is among the most common complications following open inguinal hernioplasty, potentially leading to mesh explantation, chronic infection, prolonged hospital stay, and increased healthcare costs. [1,2] Optimal strategies for prophylactic antibiotic administration continue to be debated, especially with growing concerns over antibiotic resistance. This prospective comparative study evaluated the incidence of SSIs with two prophylactic approaches: systemic intravenous (IV) antibiotics versus intra-incisional antibiotic infiltration. In this study, both groups were well-matched in terms of baseline characteristics, minimizing potential confounders such as age, sex, BMI, and type of hernia—factors known to influence infection risk and wound healing. [3,4] Importantly, the comparable demographics enhance the internal validity of our findings. The primary outcome demonstrated that while the overall SSI rates on postoperative days 2 and 4 were similar between groups, by day 7 there was a notable trend toward lower SSI incidence in the intra-incisional group (0%) compared to the IV group (9.09%), although this difference did not reach statistical significance (p=0.0785). This trend aligns with the hypothesis that direct delivery of antibiotics at the surgical site can achieve higher local drug concentrations, improving bacterial eradication during the critical early wound healing period. [5,6] Comparable studies have reported significant reductions in SSI rates with intra-incisional prophylaxis. For example, Singh et al. observed SSI rates of 5% in intra-incisional ceftriaxone recipients versus 25% in those receiving systemic antibiotics (p<0.005). [11] Similarly, Pravindhas et al. reported lower SSI rates in the intra-incisional group (6%) compared to the systemic group (20%, p=0.037). [12] Although the findings did not achieve statistical significance, the consistent trend across studies supports the clinical relevance of intra-incisional administration. The pathophysiological rationale for intra-incisional prophylaxis lies in its ability to deliver antibiotics directly to the site most at risk for contamination, ensuring high local concentrations when bacterial inoculation is likely to occur. [9] This method also minimizes systemic exposure, potentially reducing adverse effects like nephrotoxicity, allergic reactions, or the emergence of multidrug-resistant organisms—a significant concern in modern surgical practice. [10,13] Secondary outcomes in the study—including additional antibiotic requirements, hospital stay duration, readmission rates, and postoperative complications—were similar between the two groups. This suggests that intra-incisional administration is at least as safe and effective as traditional IV prophylaxis. Additionally, the absence of systemic side effects in either group further supports the safety of intra-incisional antibiotics, consistent with other studies noting no increase in delayed wound healing or localized tissue reactions. [7,14] Strengths of the study include its prospective design, homogenous study population, and standardized surgical technique, reducing variability and enhancing reliability. However, limitations include the relatively small sample size, potentially under powering the study to detect statistically significant differences, and the short postoperative follow-up limited to 7 days. Some SSIs, particularly mesh-related infections, may present later, which could underestimate true infection rates. [15] Moreover, the absence of wound cultures limited our ability to correlate prophylaxis with specific pathogens or resistance patterns. Despite these limitations, our findings support the potential of intra-incisional antibiotic prophylaxis as a safe, effective alternative or adjunct to IV antibiotics in open inguinal hernioplasty. Larger, multicenter randomized controlled trials with extended follow-up are warranted to confirm these observations and potentially guide future surgical prophylaxis guidelines.

This prospective comparative study evaluated the effectiveness of intravenous (IV) versus intra-incisional prophylactic antibiotic administration in preventing surgical site infections (SSIs) following uncomplicated open inguinal hernioplasty. While both methods were generally effective in minimizing infections, intra-incisional antibiotic infiltration demonstrated a trend toward lower SSI rates, particularly by postoperative day 7, though this difference did not reach statistical significance. Secondary outcomes—including the requirement for additional antibiotics, duration of hospital stay, readmission rates, and overall complication rates—did not differ significantly between the two groups, and both approaches were well tolerated without major adverse effects. These findings suggest that intra-incisional prophylactic antibiotics may offer a safe, practical, and potentially more targeted alternative to traditional IV antibiotic prophylaxis in patients undergoing uncomplicated open inguinal hernia repair. Given the trend toward reduced infection rates with intra-incisional administration observed in this and prior studies, larger multicenter randomized controlled trials with extended follow-up are recommended to validate these results and inform clinical practice guidelines. Until then, intra-incisional antibiotics can be considered a viable prophylactic option, especially in settings were reducing systemic antibiotic exposure and optimizing local wound protection are priorities.

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