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Saudi Pharmaceutical Journal : SPJ logoLink to Saudi Pharmaceutical Journal : SPJ
. 2023 Sep 26;31(12):101800. doi: 10.1016/j.jsps.2023.101800

Antibiotics for preventing infection at the surgical site: Single dose vs. multiple doses

Nehad J Ahmed a,b,⁎, Abdul Haseeb c, Abdullmoin AlQarni d, Manal AlGethamy e, Ahmad J Mahrous c, Ahmed M Alshehri a, Abdullah K Alahmari a, Safa S Almarzoky Abuhussain c, Ahmed Mohammed Ashraf Bashawri f, Amer H Khan b,⁎
PMCID: PMC10661588  PMID: 38028220

Abstract

Background

Surgical site infections are common and expensive infections that can cause fatalities or poor patient outcomes. To prevent these infections, antibiotic prophylaxis is used. However, excessive antibiotic use is related to higher costs and the emergence of antimicrobial resistance.

Objectives

The present meta-analysis aimed to compare the effectiveness of a single dosage versus several doses of antibiotics in preventing the development of surgical site infections.

Methods

PubMed was used to find clinical trials evaluating the effectiveness of a single dosage versus several doses of antibiotics in avoiding the development of surgical site infections. The study included trials that were published between 1984 and 2022. Seventy-four clinical trials were included in the analysis. Odds ratios were used to compare groups with 95% confidence intervals. The data were displayed using OR to generate a forest plot. Review Manager (RevMan version 5.4) was used to do the meta-analysis.

Results

Regarding clean operations, there were 389 surgical site infections out of 5,634 patients in a single dose group (6.90%) and 349 surgical site infections out of 5,621 patients in multiple doses group (6.21%) (OR = 1.11, lower CI = 0.95, upper CI = 1.30). Regarding clean-contaminated operations, there were 137 surgical site infections out of 2,715 patients in a single dose group (5.05%) and 137 surgical site infections out of 2,355 patients in multiple doses group (5.82%) (OR = 0.87, lower CI = 0.68, upper CI = 1.11). Regarding contaminated operations, there were 302 surgical site infections out of 3,262 patients in a single dose group (9.26%) and 276 surgical site infections out of 3,212 patients in multiple doses group (8.59%) (OR = 1.11, lower CI = 0.84, upper CI = 1.47). In general, there were 828 surgical site infections out of 11,611 patients in a single dose group (7.13%) and 762 surgical site infections out of 11,188 patients in multiple doses group (6.81%) (OR = 1.05, lower CI = 0.93, upper CI = 1.20). The difference between groups was not significant.

Conclusion

The present study showed that using a single-dose antimicrobial prophylaxis was equally effective as using multiple doses of antibiotics in decreasing surgical site infections.

Keywords: Antibiotics, Clinical Trials, Multiple Doses, Single Dose, Surgical Site Infections

1. Introduction

Healthcare-associated infections are infections that happen while getting medical care, develop in hospitals or other health centers, and appear forty-eight hours or more after admission to the hospital or within thirty days of receiving medical care (Haque et al., 2018). The US Centers for Disease Control and Prevention says that about 1,700,000 hospitalized patients get healthcare-associated infections every year while being managed for other health problems (Klevens et al., 2007). Patients who have surgery often get infections at the site of the surgery. This is the most prevalent infection caused by medical care (Borchardt and Tzizik, 2018).

Infection at the surgical site can affect any cavity, joint, bone, tissue, or prosthetic that was incised during or after surgery (Hall et al., 2015, Idris et al., 2020). Infections at surgical sites can be stratified into three categories based on the depth of the incision: deep incisional, superficial incisional, and infections in organs and spaces (Borchardt and Tzizik, 2018). Surgical procedures and their incisions are classified as dirty/infected, contaminated, clean-contaminated, or clean. A clean wound is “an uninfected operative wound in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tract is not entered”. Clean-contaminated is ”an operative wound in which the respiratory, alimentary, genital, or urinary tracts are entered under controlled conditions and without unusual contamination”. A contaminated wound is “ an open, fresh, accidental wound. In addition, operations with major breaks in sterile technique or gross spillage from the gastrointestinal tract and incisions in which acute, nonpurulent inflammation is encountered are included in this category”. A dirty wound is “an old traumatic wound with retained devitalized tissue and those that involve an existing clinical infection or perforated viscera“. (CDC, 1999).

If an infection develops within thirty days of surgery, or ninety days if a prosthesis was implanted, it is considered a surgical site infection (SSI) (Seidelman and Anderson, 2021). These infections are some of the most common and expensive ones that are connected to healthcare, and they can cause fatalities or poor patient outcomes (Zabaglo and Sharman, 2023). Local effects of SSI include delayed and ineffective wound healing, osteomyelitis, cellulitis, abscess formation, and the wound becoming worse over time. Systemic effects include bacteremia, which has a chance of distant hematogenous spread, and sepsis (Berríos-Torres et al., 2017).

Since SSIs are a major source of mortality and morbidity, many guidelines and standards have been established to reduce their prevalence (Edwards et al., 2006). To prevent SSIs, antibiotic prophylaxis is used (Engelman et al., 2007, Gordon et al., 1998). Nonetheless, the inappropriate use of antibiotics is one of the most serious global public health threats (Kabrah et al., 2022, Alhomoud et al., 2017, Hussein et al., 2022, Alsugoor et al., 2022, Shaheen et al., 2018, Ahmed et al., 2022a, Ahmed et al., 2022b). Using antibiotics to excess is linked to a greater risk of unpleasant effects, more frequent return visits, and increased use of medical therapy for illnesses that, if left untreated, would generally recover on their own. Furthermore, it is linked to the development of antimicrobial resistance and elevated mortality rates (Harbarth et al., 2000, Llor and Bjerrum, 2014, Kreter and Woods, 1992).

To avoid SSIs and improve postoperative recovery, a single dose of prophylactic antibiotic is recognized as a component of surgical practice in several procedures. The possible clinical advantages of giving the antibiotic in a single dose have drawn more attention in recent years (Bratzler and Houck, 2004, Gilbert et al., 2007, ASHP, 2023, Ahmed et al., 2022a, Ahmed et al., 2022b). Using a single dose of prophylaxis reduces antimicrobial resistance, diminishes superinfections and drug toxicity, and decreases care costs (Edwards et al., 2006).

New guidelines recommended the use of a reduced postoperative course of antibiotics that involves a single dosage or continuance for less than 24 h. According to a study conducted by McDonald et al., there was no discernible superiority between single- or multiple-dose regimens in terms of preventing SSIs. Consequently, they proposed the ongoing utilization of a single-dose antimicrobial prophylaxis for major surgical procedures (McDonald et al., 1998). Igwemadu et al. and Das et al. reported that antibiotic prophylaxis with one dose is just as effective as prophylaxis with several doses while being less expensive and less likely to lead to antibiotic resistance (Igwemadu et al., 2022, Das et al., 2021). Jogdand et al. stated that prophylactic use of combination chemotherapy, which is continued for 5 to 7 days, is the norm in India to prevent SSI. These prolonged treatment periods place a financial burden on the patient or the government without providing the patient with any further benefits, which ultimately results in resource waste (Jogdand et al., 2017). The aim of this meta-analysis was to examine the hypothesis that the efficacy of a single-dose antibiotic regimen is comparable to that of multiple doses of antibiotics in decreasing the incidence of SSIs.

2. Materials and Methods

PubMed was used to find studies evaluating the effectiveness of a single dosage versus several doses of antibiotics in avoiding the occurrence of SSIs. In the advanced search, the terms “surgical site infections,” single dosage,“ and ”antimicrobial“ were used.

The analysis was limited to published clinical research involving human beings. Other studies are not included in the present analysis. The study included clinical trials that compared single doses with multiple doses that were received by patients who had different types of operations. Furthermore, cross-checking of references in individual papers was conducted.

The study included trials that were published between 1984 and 2022. Most of the included trials were published in English, but there were several papers that were written in other languages, but their abstracts in English included the required data. In addition to the overall number of patients who received a single prophylactic antibiotic dose, the number of SSIs among these patients was also gathered. The study also examined the overall number of patients who received multiple prophylactic antibiotic doses and the incidence of SSIs among these patients.

The rate of SSIs in the single-dose and multiple-doses groups was the endpoint of the present study. The numbers and odds ratios of SSIs were compared between these groups. The included studies were categorized according to the types of operations that the patients had into three categories: clean operations, clean-contaminated operations, and contaminated operations.

Odds ratios were used to compare groups with 95% confidence intervals. The data were displayed using OR to generate a forest plot. The heterogeneity of the studies was analyzed using the I2 statistic. A score of 50% or higher for I2 indicated significant heterogeneity among trials. A p value of 0.05 was used as the threshold for statistical significance. Review Manager version 5.4 was used to do the meta-analysis (The Cochrane Collaboration, 2020 Copenhagen, Denmark).

3. Results

Seventy-four clinical trials were included in the analysis. The included trials were published between 1984 and 2022. The study flow chart is shown in Fig. 1.

Fig. 1.

Fig. 1

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PRISMA flow diagram.

Among the clinical trials that were included in the present study, thirty trials included clean incisions, twenty trials included clean-contaminated incisions, and twenty-four trials included contaminated incisions. Twenty-six studies were published after 2000. Table 1 shows the clinical trials that were included in the study.

Table 1.

The clinical trials that were included in the analysis.

Incision Study Type of surgery
Clean Gahm et al., 2022 Breast reconstruction
Igwemadu et al., 2022 Caesarean section
Sheth et al., 2019 Dacryocystorhinostomy
Wahab et al., 2013 Bilateral sagittal split osteotomies
Danda et al., 2010 Orthognathic surgery
Tamayo et al., 2008 Cardiac surgery
Hellbusch et al., 2008 Instrumented lumbar fusion
Lindeboom et al., 2005 Intraoral bone grafting procedures
Su et al., 2005 Gynecologic surgery
Lindeboom et al., 2003 Bilateral sagittal ramus osteotomies
Salminen et al., 1999 Cardiovascular surgery
Gagey et al., 1999 Open tibial fracture
Kester et al., 1999 Vascular surgery
Morimoto and Kinoshita, 1998 Breast cancer surgery
Hall et al., 1998 Vascular surgery
Kriaras et al., 1997 Cardiac surgery
Nooyen et al., 1994 Coronary artery bypass grafting
Morris, 1994 Upper abdominal operations
Hall et al., 1993 Cardiac operations
Galbraith et al., 1993 Cardiac operations
Wertzel et al., 1992 Thoracic surgery
Maier and Strutz, 1992 Head and neck surgery
Nachtkamp et al., 1991 Abdominal surgery
Olak et al., 1991 Thoracic surgery
Buckley et al., 1990 Hip fracture surgery
Karachalios et al., 1990 Peritrochanteric fractures
Hall et al., 1989 Abdominal surgery
Periti et al., 1988 Gynaecological and obstetric surgery
Oostvogel et al., 1987 General operations
Periti et al., 1984 Gynecologic and obstetrical surgery
Clean-Contaminated Loozen et al., 2017 Cholecystitis
Westen et al., 2015 Cesarean section
Lyimo et al., 2013 Caesarean section
Alekwe et al., 2008 Cesarean section
Sakura et al., 2008 Prostatectomy
Mohri et al., 2007 Gastric cancer surgery
Kayihura et al., 2003 Biliary surgery
Hotz et al., 1994 Maxillofacial surgery
Meijer and Schmitz, 1993 Biliary surgery
Hjortrup et al., 1991 Biliary surgery
Galask et al., 1988 Cesarean section
Roy et al., 1988 Hysterectomy
McGregor et al., 1988 Cesarean section
Fabian et al., 1988 Biliary surgery
Berkeley et al., 1988 Hysterectomy
El Mufti and Glessa, 1988 Cholecystectomy
Gall & Hill, 1987 Cesarean operation
Roy et al., 1984 Hysterectomy
Maki et al., 1984 Biliary tract operations or hysterectomy
Kellum et al., 1984 biliary operations
Contaminated Espin Basany et al., 2020 Colon surgery
Rafiq et al., 2013 Appendectomy
Ishibashi et al., 2014 Rectal cancer surgery
Ahn et al., 2013 Colorectal surgery
Oshima et al., 2013 Proctocolectomy
Fujita et al., 2007 Colorectal surgery
Mui et al., 2005 Appendicitis
Li et al., 2003 Colorectal resection
Zelenitsky et al., 2000 Colorectal surgical
Håkansson et al., 1993 Colorectal surgery
Elusoji, 1992 Appendectomy
Tsang et al., 1992 Appendectomy
Cuthbertson et al., 1991 Colorectal surgery
Rowe-Jones et al., 1990 Colorectal surgery
Hershman et al., 1990 Colorectal surgery
Periti et al., 1989 Colorectal surgery
Bittner et al., 1989 Colorectal surgery
Jagelman et al., 1988 Colorectal surgery
Juul et al., 1987 Colorectal surgery
Stubbs et al., 1987 large bowel surgery
Fabian et al., 1984 Colorectal surgery or small bowel obstruction
Göransson et al., 1984 Colorectal surgery
Lohr et al., 1984 Colorectal surgery
Viitanen et al., 1984 Appendectomy
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Regarding clean operations, there were 389 SSIs out of 5,634 patients in a single dose group (6.90%) and 349 SSIs out of 5,621 patients in multiple doses group (6.21%) (OR = 1.11, lower CI = 0.95, upper CI = 1.30). Fig. 2 shows the forest plot of the clinical trials that included clean operations. There was no significant difference observed in the incidence of SSIs between individuals who received a single dosage and those who received repeated doses of antibiotics (P = 0.18).

Fig. 2.

Fig. 2

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The forest plot of the clinical trials that included clean operations.

The heterogeneity of the trials that included clean operations was low, as shown in Fig. 3. Furthermore, the heterogeneity I2 was 0, and the p value of the heterogeneity was not significant (p = 0.46).

Fig. 3.

Fig. 3

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Funnel plot of the trials that included clean operations.

Regarding clean-contaminated operations, there were 137 SSIs out of 2,715 patients in a single dose group (5.05%) and 137 SSIs out of 2,355 patients in multiple doses group (5.82%) (OR = 0.87, lower CI = 0.68, upper CI = 1.11). Fig. 4 shows the forest plot of the clinical trials that included clean-contaminated operations. As shown in the figure, the difference between the efficacy of a single-dose group and a multiple-doses group was not statistically significant (P = 0.27).

Fig. 4.

Fig. 4

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The forest plot of the clinical trials that included clean-contaminated operations.

The heterogeneity of the trials that included clean-contaminated operations was low, as shown in Fig. 5. Furthermore, the heterogeneity I2 was 0, and the p value of the heterogeneity was not significant (p = 0.79).

Fig. 5.

Fig. 5

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Funnel plot of the trials that included clean-contaminated operations.

Regarding contaminated operations, there were 302 SSIs out of 3,262 patients in a single dose group (9.26%) and 276 SSIs out of 3,212 patients in multiple doses group (8.59%) (OR = 1.11, lower CI = 0.84, upper CI = 1.47). Fig. 6 shows the forest plot of the clinical trials that included clean-contaminated operations. As shown in the figure, the difference between the efficacy of a single-dose group and a multiple-doses group was not statistically significant (P = 0.44).

Fig. 6.

Fig. 6

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The forest plot of the clinical trials that included contaminated operations.

Fig. 7 shows the funnel plot of the trials that included contaminated operations. The heterogeneity of the trials was high, as shown in the funnel plot, and the heterogeneity of I2 was more than 50% and p = 0.002.

Fig. 7.

Fig. 7

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Funnel plot of the trials that included contaminated operations.

A sensitivity analysis was conducted to decrease the heterogeneity. After that, the Håkansson et al. study was removed from the analysis. The I2 decreased to 34% after deleting the study (Fig. 8). Regarding contaminated operations, there were 283 SSIs out of 2,975 patients in a single dose group (9.51%) and 232 SSIs out of 2,932 patients in a multiple doses group (7.91%) (OR = 1.21, lower CI = 0.95, upper CI = 1.54). The difference between the efficacy of a single-dose group and a multiple-doses group was not statistically significant (P = 0.13).

Fig. 8.

Fig. 8

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The forest plot of the clinical trials that included contaminated operations after conducting sensitivity analysis.

Fig. 9 shows the forest plot of the clinical trials that included all of the operations (clean, clean-contaminated, and contaminated operations). There were 828 SSIs out of 11,611 patients in a single dose group (7.13%) and 762 SSIs out of 11,188 patients in multiple doses group (6.81%) (OR = 1.05, lower CI = 0.93, upper CI = 1.20). As shown in the figure, the difference between the efficacy of a single-dose group and a multiple-doses group was not statistically significant (P = 0.44).

Fig. 9.

Fig. 9

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The forest plot of the clinical trials that included all of the operations.

Fig. 10 shows the funnel plot of the seventy-four clinical trials that were included in the analysis. In general, the included studies were sufficiently homogeneous (I2 less than 50%, p = 0.06).

Fig. 10.

Fig. 10

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Funnel plot of the seventy-four clinical trials.

4. Discussion

Surgical antimicrobial prophylaxis is a recognized component of surgical practice in specific operations to reduce SSIs and improve postoperative recovery. When people take too many antibiotics before surgery, they are more likely to have side effects, have to come back more often and get treatment for infections that would go away on their own. It is also linked to the development of bacteria that are resistant to antibiotics. For operations where there is evidence of benefit, using a single dose of antibiotic before the surgical incision is usually sufficient. Calderwood et al. (2023) reported that antimicrobial prophylaxis should be discontinued at the time of surgical closure in the operating room. Nonetheless, repeat intraoperative doses are indicated for lengthy procedures where a short-acting medication is used or if remarkable blood loss occurs.

Our study showed that the difference in the rate of SSIs between the single-dose group and the multiple-doses group was insignificant. Similar to the result of the present study, previous studies found that a single-dose prophylaxis is as effective as multiple-dosage antibiotic prophylaxis in reducing the occurrence of SSIs (Akkour et al., 2020, McDonald et al., 1998, Gahm et al., 2022, Vathana and Muhunthan, 2018, Mugisa et al., 2018, Slobogean et al., 2010, Igwemadu et al., 2022, Kannan et al., 2021, Koirala et al., 2019, Bhatnagar et al., 2017, Salkind and Rao, 2011; Basany et al., 2020; Ahn and Lee, 2013, Ishibashi et al., 2014). Furthermore, Das et al. reported that there are no notable differences between single-dose and multiple-doses antibiotic prophylaxis to prevent SSIs in patients undergoing elective clean-contaminated and clean operations and that a single dosage is more cost-effective (Das et al., 2021). Pooja et al. reported that the use of a single-dose antibiotic regimen should be advocated to reduce antibiotic resistance while also being cost-efficient (Pooja et al., 2021). Moreover, Kannan et al. reported that using extra doses of cefazolin after surgery provides no benefit over the use of a single dose and that a single-dose regimen has the advantages of reduced resistance emergence, fewer allergies or toxicity, and lower cost (Kannan et al., 2021).

Previous meta-analyses compared the use of single-dose vs. multiple-dose regimens. Similar to our results, they found no significant differences between single-dose and multiple-dose regimens in reducing SSIs. Several meta-analyses included clean incisions. They failed to show that multiple-dose prophylaxis was superior to a single-dose method in terms of lowering the SSI rate (Slobogean et al., 2008, Morrison et al., 2012, Ryan et al., 2019, Gillespie and Walenkamp, 2010, Costa and Krauss-Silva, 2004, Barker, 1994, Barker, 2002). Meijer et al. and Zhang et al. included clean-contaminated incisions in their meta-analyses. They evaluated wound infection rates between single-dose and multiple-dose regimens and found no significant difference (Meijer et al., 1990, Zhang et al., 2013). Furthermore, two meta-analyses included contaminated incisions. When comparing single-dose to multiple-dosage antibiotics, they found no statistically significant differences (Nelson et al., 2009, Nelson et al., 2014).

The present study showed that there was no remarkable difference between multiple doses and a single dose of antibiotic prophylaxis in preventing SSIs. Nonetheless, the patients should receive more than one dose for prolonged operative duration or in the case of severe blood loss. According to the Scottish Intercollegiate Guideline Network, there is consistent evidence that prophylaxis for the duration of the surgery alone is sufficient. Prophylaxis for longer periods had no remarkable benefit (SIGN, 2014). According to Munckhof et al., a single dosage of antibiotic is normally sufficient if the surgery lasts 4 h or less (Munckhof et al., 2005). Dehne et al. reported that surgery duration of more than 4 h or predicted blood losses of more than 1.5 L necessitate repeat intraoperative dosing of antibiotics (Dehne et al., 2001). Prophylactic antibiotics should be stopped within twenty-four hours, according to Crader and Varacallo (Crader and Varacallo, 2023). The Saudi Ministry of Health informed that the length of antimicrobial prophylaxis after surgery should be limited to less than twenty-four hours, regardless of the existence of indwelling catheters, drains, or prostheses (MOH, 2021). Ongom et al. (2013) reported that for prophylaxis duration, a shorter course of antibiotics after surgery is recommended. Even if there are indwelling drains and intravascular devices, the duration of prophylaxis should be less than 24 h (Ongom et al., 2013).

Our findings indicated that the administration of a single dose of prophylactic antibiotics significantly reduces the risk of infection, without the need for additional doses. This approach is not only more convenient for patients, but it also reduces the risk of antibiotic resistance and associated side effects. Therefore, we highly recommend the use of single-dose prophylaxis for all patients undergoing surgical procedures, regardless of the classification of their wounds.

The main strength of the present study was that it included seventy-four clinical trials. There were several previous meta-analyses that compared the use of single doses vs. multiple doses, but they focused on specific operations and included only a few trials. Nonetheless, there are several limitations to the current study. The first limitation of the study was that the antibiotics employed in the various studies were not standardized for all of the clinical trials that were included in the analysis. The remarkable discrepancy between the number of cases in the control and intervention groups in several trials was the second limitation. This would have an impact on the odd ratio comparisons. Furthermore, the quality of the studies included in the meta-analysis can vary, leading to potential bias and affecting the overall results. The fourth limitation was that several trials were available as abstracts only and didn’t contain the required information in the abstract, so they were excluded from the study. Limited data availability or incomplete reporting can limit the ability to conduct a comprehensive meta-analysis. Moreover, SSI trials that do not include prospective, direct observation can be biased because relying on patient self-reporting or retrospective chart review may lead to underreporting of infections.

5. Conclusion

The present study showed that single-dose antimicrobial prophylaxis was equally effective as multiple-dose antimicrobial prophylaxis in decreasing the occurrence of SSIs. So, a single-dose antibiotic regimen can be safely practiced before clean, clean-contaminated, and contaminated incisions.

Declaration of competing interest

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Acknowledgment

The authors extend their appreciation to the Deputyship for Research & Innovation, Ministry of Education in Saudi Arabia for funding this research work through the project number IFP22UQU4290073DSR133

Footnotes

Peer review under responsibility of King Saud University. Production and hosting by Elsevier.

Contributor Information

Nehad J. Ahmed, Email: pharmdnehadjaser@yahoo.com, n.ahmed@psau.edu.sa.

Abdul Haseeb, Email: amhaseeb@uqu.edu.sa.

Manal AlGethamy, Email: mmalgethamy@moh.gov.sa.

Ahmad J. Mahrous, Email: ajmahrous@uqu.edu.sa.

Amer H. Khan, Email: dramer2006@gmail.com.

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