Comparison of the incidence of surgical site infections in patients who receive clindamycin vs. beta-lactam antibiotics for pediatric gastrointestinal surgery
Authors: Joe Jae H , Breckler Francine , Bhumbra Samina S , Mararu Rodica loana 
Published: January 2025

Abstract

Corresponding Author: Jae H Joe, PharmD, MPH, 1701 N Senate Ave, Indianapolis, IN 46202, 470-354-9370, jjoe@iuhealth.org
Francine, Breckler, PharmD, BCPPS, 705 Riley Hospital Dr, Indianapolis, IN 46202, 317-944-2026, fbreckle@iuhealth.org

Background
Surgical Site infections (SSIs) are one of the most common types of hospital-acquired infections and pose a substantial risk of morbidity and mortality1. The impact on the healthcare system has been estimated to be approximately $25,000 per case1. According to the Infectious Disease Society of America (IDSA) guidelines for antimicrobial prophylaxis in surgery, antibiotics play an essential role in reducing the rate of potential SSI risks2. The antimicrobial agents used to prevent SSIs should have activity against the most common bacteria anticipated to be present for the intended surgical gastrointestinal procedure, such as G-tube placement or colostomy. The IDSA guideline recommends beta- lactams such as cefazolin or cefoxitin as a first-line therapy due to cost, effectiveness, and safety, depending on where in the gastrointestinal tract (GI tract) the operation is occurring. However, in patients with a beta-lactam allergy, including penicillin, cephalosporin, and carbapenem classes, it is recommended to use non-beta lactam agents such as clindamycin or vancomycin as an alternative. However, data suggest a higher rate of SSIs in patients who received clindamycin based on local susceptibility patterns and pharmacokinetic profile2. Approximately 10% of the U.S. population reports a penicillin allergy3. Hypersensitivity is a significant adverse reaction to penicillin. However, a true penicillin allergy is rare, with an estimated anaphylactic reaction of 1 to 5 per 10,000 cases despite high reporting rates4. This demonstrates that there are a large number of patients who are qualified for first-line therapy but do not receive it due to unverified allergy reports. Our institutional guidelines for GI tract surgical site antimicrobial prophylaxis, including recommendations for gastrostomy tube placement/removal, cholecystectomies, ostomy creation/reversal, and pilonidal cyst debridement recommend the use of vancomycin or clindamycin ± gentamycin for use in beta-lactam allergic patients. Due to workflow issues in the operating room, clindamycin is the preferred antibiotic. This study addressed the incidence of SSIs in pediatric patients who received either clindamycin or beta-lactam in patients who underwent an elective GI tract procedure. Our hypothesis was that clindamycin would have a higher incidence of SSIs compared to those who received a beta-lactam antibiotic.

Methods
A retrospective chart review of pediatric patients who received either a beta-lactam or clindamycin prior to an elective GI tract surgery (gastrostomy tube placement/removal, cholecystectomies, ostomy creation/reversal, and pilonidal cyst debridement) as perioperative infection prophylaxis from 2014 to 2022 was conducted. Demographic data was collected which included age, sex, ethnicity, surgery type, antibiotic received, beta-lactam allergy status, type of reaction, duration of surgery, antibiotic administration within 60 minutes of incision and SSI rate. Patients included were 1-18 years and had clinic follow-up within 30 days. Patients who were less than 1 year and greater than 18 years old or being treated for an active infection at the time of the surgery were excluded. Given the retrospective nature of this study, all patients meeting study criteria from 2014-2022 were included. Descriptive statistics were utilized for the analysis of group characteristics. Categorical values are depicted using numerical counts (N) and percentages, while continuous variables are outlined by mean, median, IQR, range, and standard deviation (SD). Then, the Chi-square test of Fisher’s exact test was used to compare the two groups for statistical differences in the proportion of patients with surgical site infection. Baseline characteristics were compared using independent t-tests for equality of variance for continuous variables and the Chi-square test or Fisher’s exact tests for categorical variables. A two-sided 5% significance level was used for all tests. The power analysis using power two proportions in STATA 16 was used to assess the power between the main outcome (surgical site infection) and the antibiotic groups (beta- lactam versus Clindamycin). The power for the sample of 123 cases (38 cases in the beta-lactam group 85 cases in the Clindamycin group, and 5 cases of infection in the beta-lactam group and 5 cases of infection in the Clindamycin group) = 0.3017. (Note: a desired power level is ≥ 0.8 to detect an effect). A p-value below 0.05 was considered significant.

Results
A total of 184 cases were included in the study. 73 cases or 39.7% received beta-lactam and 111 cases or 60.3% received clindamycin. The median age of the patients was 14 years. The clindamycin group had a median age of 14 years which was significantly older than the beta- lactam group (p&lt;0.001). Other demographic data is summarized in Table 1. Among the 184 cases, 61.4% (n=113) had no postoperative SSI, 5.4% (n=10) had a superficial SSI and no patients had developed an organ space infection. There were 33.2% (n=61) which had no clinic follow-up so were not included in the analysis. The number of SSI were equally distributed between both groups (13.2% vs. 5.9%, p= 0.28). All patients received perioperative antibiotics within 60 minutes of the incision. Table 2 describes the incidence of an allergy, reaction type, and duration of surgery.
Table 1. Baseline demographics

Table 2. Primary and secondary outcomes

Conclusion
This study found no statistical significance when comparing the incidence of postoperative surgical site infections in pediatric patients undergoing GI surgery who receive clindamycin vs. a beta-lactam antibiotic for perioperative prophylaxis. Moreover, there was no statistical significance observed when comparing the duration of surgery or the timing of antibiotics. Limitations included this studying being a retrospective chart review and small sample number. Future research at our institution will focus on expanding review of surgical patients receiving either clindamycin or a beta-lactam antibiotic for surgical site infections with the desire to develop an algorithm for appropriate use.

References
1. Wilhelm NB, Bonsall TJ, Miller CL. The Effect of Beta-lactam Allergy Status on the Rate of Surgical Site Infections: A Retrospective Cohort Study. Ann Surg. 2022;275(1):208-12.
2. Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, et al. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013;14(1):73-156.
3. Mitchell AB, Ness RA, Bennett JG, Bowden JE, Elliott WV, Gillion AR, et al. Implementation and Impact of a β-Lactam Allergy Assessment Protocol in a Veteran Population. Fed Pract. 2021;38(9):420-5.
4. Bhattacharya S. The facts about penicillin allergy: a review. J Adv Pharm Technol Res. 2010;1(1):11-7.