Antibiotic Prophylaxis in Clean Head and Neck Surgery: An Observational Retrospective Single-Centre Study

Abstract

Introduction:

Surgical site infection (SSI) is a common complication in surgery. In head and neck surgeries, different rates are reported in the indexed literature. Nowadays, this indiscriminate use of antibiotics is associated with increased cost and risks for patients. Antimicrobial misuse has also contributed to the development of antibiotic-resistant bacteria.

Patients and Methods:

A total of 204 patients were included in this observational retrospective cohort study. The primary outcome of this study was to describe the rate of SSI. Wound infection was considered as SSI and was defined as any cellulitis or pus drainage requiring treatment with antibiotics.

Results:

Of all, 127 were included in group A (not antibiotic) and 77 in group B (antibiotic prophylaxis); 109 (53.5%) patients were male, and 97 (47.5%) were female. Four (3.14%) patients developed SSI in group A and 3 (3,89%) developed SSI in group B, being not statistically significant (P = .592). In group A, 2 patients suffered SSI after a submandibular gland resection (SGR), 1 patient after a parotid gland resection (PGR), and another one after a branchial cleft cyst resection. In group B, 1 patient suffered SSI after an SGR and 2 after a PGR. On univariate and multivariate analyses, we did not find any variable associated with the development of SSI.

Conclusion:

According to our results, the prophylactic antibiotic in clean, benign head and neck surgery is not necessary. Nevertheless, physicians and surgeons should be aware that severe or even fatal SSIs might be developed, and it needs to be explained to our patient before any surgery.

Keywords

antibiotic prophylaxis head neck benign clean

Introduction

Surgical site infection (SSI) is a common complication in surgery. In head and neck surgeries, different rates are reported in the indexed literature (3.5%-87%).¹ The frequency of SSI reported for clean head and neck surgical procedures without antimicrobial prophylaxis is less than 1%.^2,3 However, studies regarding the use of prophylactic antibiotics have shown the decrease in the risk of SSIs in the clean-contaminated and contaminated head and neck surgeries.⁴

According to the World Health Organization, “clean surgery” refers to an uninfected operative wound in which no inflammation is encountered in which respiratory, alimentary, genital, or uninfected urinary tracts are not entered. In addition, clean wounds are primarily closed and if necessary drained with closed drainage. Operative incisional wounds that follow nonpenetrating (blunt) trauma should be included in this category if they meet the criteria.⁵ Surgical guidelines do not recommend the use of antibiotics in clean head and neck surgeries owing to the general absence of evidence of their value in this setting.⁶ Nevertheless, nonadherence to the guidelines is widespread and published data from one study report rate of inappropriate antibiotic administration in clean head and neck surgeries over 40%.⁷

Nowadays, this indiscriminate use of antibiotics is associated with increased cost and risks for patients.⁸ Antimicrobial misuse has also contributed to the development of antibiotic-resistant bacteria.⁹ This is of concern, particularly if widening resistance renders available antibiotics ineffective, in addition to commonly cited side effects.¹⁰

Since 2016, antibiotic prophylaxis has not been used for benign clean head and neck surgery in our department. This is the reason why the present study aimed to investigate the effects of prophylactic antibiotic administration in clean head and neck surgery for benign masses, analyzing retrospective data from an Otorhinolaryngology–Head & Neck Surgery Department in a Tertiary University Hospital.

Material and Methods

After approval of the ethical committee of our centre (CCH-HUD: 00717), 204 patients were included in this observational retrospective cohort study. Clinical and demographic variables were obtained from clinical history, and the study was performed in accordance with the ethical standards laid down in the Declaration of Helsinki.

Patients were divided into 2 groups based on whether antimicrobial prophylaxis was administered. In group A, patients operated between June 2016 and June 2018 for benign tumors of the head and neck region in which antibiotic prophylaxis was not used were included. The group B corresponds to those patients operated between June 2010 and June 2012 for similar pathologies, receiving antibiotic prophylaxis. Patients with malignant histology, previous surgery, previous neck irradiation, immunosuppression, concurrent infection requiring antibiotic treatment, or those who receive antibiotic due to the surgeon decision (intraoperative rupture of the capsule) were excluded. All surgeries were performed following standard techniques. Patients in group B received antibiotic prophylaxis with a single dose of intravenous 2 g amoxicillin/clavulanate in 100 mL of 0.9% NaCl. The drug was given about 30 to 60 minutes before starting surgery. The primary outcome of this study was to describe the rate of SSI. Wound infection was considered as SSI and was defined as any cellulitis or pus drainage requiring treatment with antibiotics.

Statistical analysis was performed using SPSS for Windows, version 20.0 (SPSS, Inc, Chicago, Illinois). Normality of distribution for continuous variables was assessed using the Kolmogorov-Smirnov test. Quantitative variables in the study were expressed as mean ± standard deviation. Demographic data in both groups were compared using unpaired Student t tests for continuous variable. Pearson χ² test was used to analyze categorical variables. Univariate and multivariate analysis were performed. A P value <.05 was considered statistically significant.

Results

Two hundred four patients were included in the final analysis: 127 in group A and 77 in group B; 109 (53.5%) patients were males and 97 (47.5%) were females. Table 1 summarizes the demographic data of both groups. Comparing both groups using Kolmogorov-Smirnov test yields P = .407, which means our data were normally distributed. Four (3.14%) patients developed SSI in group A and 3 (3.89%) developed SSI in group B, being not statistically significant (P = .592; Table 2). According to the type of surgeries related to SSIs, in group A, 2 patients suffer SSI after a submandibular gland resection (SGR), 1 patient after a parotid gland resection (PGR), and another one after a branchial cleft cyst resection. In group B, 1 patient suffered SSI after an SGR and 2 after a PGR. On univariate and multivariate analyses, we did not find any variable associated with the development of SSI. Other complications like seroma or salivary fistula may be consulted in Table 2. The type of salivary gland pathology in both groups may be consulted in Table 3.

Table 1.

Demographic Data and Surgical Technique Performed.

Variables	Group A, n (%)	Group B, n (%)	Total (%)	P
Mean age	53.8; Min: 18/Max: 80 ± 16	52.33; Min: 22/Max: 82 ± 13	53; Min: 18/Max: 82 ± 15
Male	66 (51.96)	43 (55.8)	109 (53.5)	.261
Female	61 (48.04)	36 (46.2)	97 (47.5)	.109
Hypertension (HTA)	41 (32.3)	20 (25.9)	61 (29.9)	.215
Diabetes Mellitus (DM)	18 (14.17)	13 (16.9)	31 (15.2)	.372
Thyroglossal duct cyst	11 (8.66)	6 (7.8)	17 (8.3)	.485
Branchial cleft cyst	16 (12.59)	3 (3.9)	19 (9.31)	.497
Dermoid cyst	2 (1.57)	4 (5.19)	6 (2.94)	.852
Neck lipoma	8 (6.29)	0	8 (3.92)	Not calculated
Ectopic thyroid tissue	2 (1.57)	0	2 (0.98)	Not calculated
Nerve Sheath tumor	4 (3.14)	0	4 (1.96)	Not calculated
Submandibular gland resection	18 (14.17)	15 (19.48)	33 (16.17)	.374
Parotid gland resection (benign tumors)	69 (54.3)	49 (63.6)	118 (57.8)	.058
Total	127	77	204	Not calculated

^aGroup A correspond to those patients who don’t receive prophylaxis antibiotic. Group B correspond to those patients who receive prophylactic antibiotic.

Table 2.

Type of Complication Suffer by Patients Included According to Each Group.

Type of complication	Group A, n (%)	Group B, n (%)	p
Surgical Site Infection	4 (3.14)	3 (3.89)	.592
Seroma	5 (5.93)	4 (5.19)	.614
Salivary fistula	3 (2.36)	2 (2.59)	.527
Total	12 (9.44)	9 (11.68)	.342

Table 3.

Type of Salivary Gland Pathology According to Each Group.

	PGR	SGR
Group A
Pleomorphic adenoma	31	4
Warthin tumor	30	0
Oncocytoma	3	0
Chronic sialoadenitis	0	3
Lithiasis	1	11
Group B
Pleomorphic adenoma	24	0
Warthin tumor	19	0
Oncocytoma	4	0
Myoepithelioma	2	0
Chronic sialoadenitis	0	1
Lithiasis	0	14

Abbreviations: PGR, parotid gland resection; SGR, submandibular gland resection.

Discussion

Clean head and neck surgery includes thyroidectomy, parathyroidectomy, salivary gland excisions (parotid and submandibular glands), congenital neck masses (branchial cleft cyst and thyroglossal duct cyst), nerve sheath tumors, and neck dissections. In a recent systematic review performed with the support of the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS) Patel et al’s recommendation was against the use of antibiotic prophylaxis in clean head and neck Surgery.¹⁰ According to our result, we agree with this postulate, considering prophylaxis not necessary in benign clean head and neck surgery (3.14 vs 3.89, P = .592).

There are some publications in the indexed literature regarding low infection rates without the use of antibiotics in different case series; these data suggest prophylaxis might be not necessary for thyroidectomy^11

-18 and parotidectomy.^19,20 A randomized controlled trial including 500 patients showed no difference in SSI rates with or without a single dose of intraoperative ampicillin/sulbactam in clean head and neck surgery (thyroidectomy; 0.01% vs 0.02%).¹ Another observational retrospective study published in 2017 reported no difference in the frequency development of SSIs after thyroidectomy, parathyroidectomy, and neck dissection between patients receiving antibiotic prophylaxis with cefuroxime and those having no prophylaxis.²¹ Findings were also in agreement with guidelines that routine antibiotic prophylaxis in clean neck surgery does not reduce the risk of SSIs.²² As we can see, the majority of these papers are related to the use of prophylaxis in thyroid or parathyroid surgery; this is the reason why we consider our results might add significant information to the published literature due to the inclusion of patients treated by salivary gland pathology (tumors, lithiasis, or chronic sialoadenitis), nerve sheath tumors, neck lipoma, or congenital neck masses (branchial cleft cyst, dermoid cyst, or thyroglossal duct cyst). Also, this could explain the difference between our results and findings shown in those studies, as well as the similarities with data published by Bova et al¹⁹: 1.1% in pediatric parotid surgery, or Carter et al²⁰: 2.3% in parotid gland surgery for benign or malignant pathology and better than those published by Burgess and Serpell (10.4%).²³

Neck dissection was not considered in this study, given some factors such as greater tissue exposure, poor nutritional status, extended surgical time, history of previous radiation, and oncological status, factors that may increase the infection risk in those patients. However, our results make us think about the possibility to avoid the use of prophylaxis in well-selected cases and to start a prospective trial to obtain good quality data related to this topic.

Finally, it is important to highlight that our findings are limited by the retrospective nature of our study besides the relatively small number of patients. Nevertheless, physicians and surgeons should be aware that severe or even fatal SSIs might be developed and it needs to be explained to our patient before any surgery.²⁴ Also, factors like nutritional status and patient comorbidities need to be correctly assessed before surgery to reduce the risk of SSI.

Conclusion

According to our results, the prophylactic antibiotic in clean–benign head and neck surgery as salivary gland pathology (tumors, lithiasis, or chronic sialoadenitis), nerve sheath tumors, neck lipoma, or congenital neck masses (branchial cleft cyst, dermoid cyst, or thyroglossal duct cyst) is not necessary. Nevertheless, physicians and surgeons should be aware that severe or even fatal SSIs might be developed and it needs to be explained to our patient before any surgery.

Footnotes

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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