- Department of Neurosurgery, Cairo University Hospitals, Cairo University, Cairo, Egypt.
- Department of Neurosurgery, Benha University, Cairo, Egypt.
Correspondence Address:
Mohammad Elbaroody, Department of Neurosurgery, Cairo University Hospitals, Cairo University, Cairo, Egypt.
DOI:10.25259/SNI_640_2021
Copyright: © 2021 Surgical Neurology International This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-Share Alike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.How to cite this article: Ahmed Atallah1, Mohammad Elbaroody1, Ahmed A. Aziz N. Hassan1, Ahmed M. Ali1, Mohamed E. Elhawary2. Role of topical vancomycin in reduction of postoperative infections in head trauma patients: A developing country experience. 08-Dec-2021;12:600
How to cite this URL: Ahmed Atallah1, Mohammad Elbaroody1, Ahmed A. Aziz N. Hassan1, Ahmed M. Ali1, Mohamed E. Elhawary2. Role of topical vancomycin in reduction of postoperative infections in head trauma patients: A developing country experience. 08-Dec-2021;12:600. Available from: https://surgicalneurologyint.com/surgicalint-articles/11273/
Abstract
Background: Postoperative cranial wound infections are a major cause of morbidity, mortality, and financial burden, especially in developing countries.
Methods: We prospectively studied 86 patients in a randomized trial; 39 patients received one gram of topical vancomycin powder in the subgaleal space while 47 matched control patients did not. Both groups received identical intraoperative and post-operative care. The primary outcome variable was the postoperative wound infections rate factored by cohort. Secondary outcomes were the timing of infection and the rate of adverse events.
Results: Adding topical vancomycin was associated with a significantly lower rate of infection than the standard of care alone (2.6% [1/39] vs. 14.9% [7/47], P =.004). No adverse reactions occurred.
Conclusion: Topical vancomycin is safe, and effective in the prevention of surgical site infections following craniotomy. These findings have broad consequences for neurosurgery practice, especially in developing countries with high incidence of head trauma.
Keywords: Craniotomy, Head trauma, Surgical-site infection, Vancomycin, Wound
INTRODUCTION
Surgical site infections (SSIs) are the most common complication encountered in surgically treated patients.[
MATERIALS AND METHODS
Study design
We obtained an institutional review board approval for a single-center, prospective, randomized controlled study of patients undergoing cranial surgery after head trauma to determine whether topical vancomycin reduces the risk of postoperative wound infections or not.
Study population
The study was conducted in the department of neurosurgery, faculty of medicine, Cairo University, Egypt in the period from January 2020 to September 2020 on head trauma patients who needed cranial surgery, and met the inclusion criteria. All procedures performed were approved by Institutional Review Board (MS-193-2020), and informed consent was obtained from each of the patients or their families.
Inclusion criteria were as follows: Head trauma adult patients 13–65 years, Glasgow Coma Score (GCS) (9–15) on admission, and fit for surgery. Exclusion criteria were as follows: Age <13 and >65 years, elective cranial surgery cases, high-risk medical condition, GCS <9.
Patient selection and study intervention
This study included 86 patients of various age groups who were randomly assigned into two groups: Group A, 39 patients receiving 1 g of topical vancomycin powder in the subgaleal space (case group); and group B, 47 matched patients without application of topical vancomycin.
We gave intravenous cefazolin within 30 min of incision and continued for 48 h, we used betadine to clean the skin after shaving. Patients in the vancomycin cohort received 1 g of vancomycin powder sprinkled evenly in the subgaleal flap over the bone flap after the final wound irrigation before closure. Wounds were closed in layers and covered by dressings. We removed dressings on postoperative day 1, while sutures were removed in the 14th postoperative day.
In the follow-up clinic, we looked for local signs of infection e.g. pus, collection, fever, tenderness; patient with those signs were admitted, then swab from the wound taken for culture and sensitivity followed by empirical intravenous antibiotics. Patients either continue on conservative treatment or surgical debridement could be done according to clinical situation.
Follow-up and study’s outcomes
Patients were then followed up for up to 120 days to assess the study’s outcomes. The primary outcome variable SSI was defined as culture-positive wound infection within 120 d of surgery. The secondary outcomes were the timing of infection and the rate of adverse events.
Sample size calculation
The minimum sample size was calculated by using PASS software (PASS 11 citation: Hintze J (2011). PASS 11. NCSS, LLC. Kaysville, Utah, USA). Based on the previous report by Mallela and colleagues, the addition of topical vancomycin was associated with a significantly lower rate of SSI than the standard of care alone (0.49% [1/205] vs. 6% [9/150], P = 0.002).[
Statistical methods
Data were collected, tabulated, statistically analyzed with Statistical Package of Social Science version 20 and Epi Info 2000 programs. Descriptive statistics: in which quantitative data were presented in the form of the mean (
RESULTS
A total of 112 patients of various age groups were involved in traumatic cranial neurosurgical procedures at the neurosurgery department in Cairo University Hospitals. Out of 112 patients, 26 patients were excluded due to either not meeting the inclusion criteria (n = 17) or refused to sign the written informed consent (n = 9). Thus, a total of 86 patients were included in the present analysis. According to the type of intervention to be used, patients were randomly allocated into 2 groups: Group A: 39 patients receiving 1 g of topical vancomycin powder in the subgaleal space (case group), and Group B: 47 matched patients without application of topical vancomycin. [
There was no statistically significant difference between males and females in terms of percentages. The mean age was roughly equal with no significant difference between groups. Regarding patients’ factors that could be linked to postoperative infection, there were no statistically significant differences between studied groups regarding the smoking (P = 0.65), hypertension (P = 0.9), and diabetes (P = 0.65). Regarding pathological cause, In the vancomycin group, compound depressed fractures were the most common pathology (58.9%); while in the control group, they were equal to unilateral to extradural hematoma (40.4%). [
The main outcome which is SSI was lower in the patients in the vancomycin group (P = 0.04), however; There was no statistical difference between the studied groups regarding the interval till infection occurs, complications, and mortality. [
DISCUSSION
Topical vancomycin has proved itself as a valuable drug in the decrease of postoperative infection in cranial surgery in many studies.[
The incidence of postoperative central nervous system infections varied in the literature from 0.8%,[
Serum vancomycin levels stay normal therapeutic or subtherapeutic to undetectable after intrawound vancomycin therapy, although local wound concentrations exceed the least inhibitory concentration required to treat most covered bacteria.[
Abdullah et al.,[
Given the broad-spectrum gram-positive coverage provided by vancomycin, there are additional concerns about selecting gram-negative, anaerobic, and vancomycin-resistant bacterial SSIs.[
In our series, a single patient treated with topical vancomycin experienced an infection postoperatively, whereas seven patients in the control group developed an infection (P = 0.04), mortality occurred in a single patient in the vancomycin group, while occurred in five patients in the control group (P = 0.143).
Thus, while our study represents some guarded initial evidence of the efficacy of topical vancomycin in head trauma patients, we hope it will generate more interest in topical vancomycin for all craniotomy patients, which will lead to larger and more definitive studies on its efficacy. As is the case in many other studies, the data were collected from a patient population at a single institution, and may not be representative of populations across Egypt, to overcome this constraint, future studies could collect data from multiple institutions and combine the results. Also, double-blinded randomized trials would strengthen the findings in this prospective study.
Postoperative cranial wound infections have a substantial cost in terms of both morbidity and patient hospitalization. Deep cranial wound infections can affect the bone flap, dura mater, and brain, requiring repeated operations and antibiotic treatment.[
Study limitations
There are many limitations in this study, although this study was a prospective randomized study, it was not double-blinded, however; the study cohorts were well balanced in terms of demographics, risk factors, and technical operations. We include all cranial surgeries across head trauma patients, but not all surgeries were performed by a single surgeon. The sample size was small in comparison to other cohorts,[
CONCLUSION
Topical vancomycin significantly reduces the risk of postoperative cranial wound infections in head trauma patients. The effect of vancomycin against gram-positive was more obvious than gram-negative bacteria. Nevertheless, large practices with large case volumes are necessary to accrue sufficient sample sizes to detect small differences between groups.
Declaration of patient consent
The authors certify that they have obtained all appropriate patient consent.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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Rajan Talukder
Posted September 9, 2023, 2:22 pm
Dear author / concern,
The sampling method used here is not clear to me. I would like to know about it more.
Regards