Antibiotic prophylaxis in thyroid surgery: a preliminary multicentric italian experience
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Post-operatory wound infections are a very uncommon finding after thyroidectomy. For these reasons international guidelines do not routinely recommend systemic antibiotic prophylaxis.
The benefits of this antibiotic prophylaxis is not supported by clinical evidence in the literature. We have conducted a multicentric randomized double-blind trial on 500 patients who had undergone thyroidectomy for goitre or thyroid carcinoma. The 500 patients enrolled in the study (mean age 47 years) were randomized in two subgroups of 250 patients. 250 patients were treated with standard antibiotic prophylaxis with sulbactam/ampicillin 1 fl (3 gr.) 30 min before surgery. No antibiotic prophylaxis was instituted in the remainder 250 patients. Our RCT showed that prophylactic antibiotic treatment is not beneficial in patients younger than eighty years old, with no concomitant metabolic, infective and hematologic disease, with no cardiac valvulopathies, not under steroidal or immunosuppressive treatment, and not severely obese. Our study should be regarded only as a preliminary RCT, and should be followed by a study in which a larger number of patients should be enrolled so that statistically significant data can be obtained.
KeywordsAntibiotic Prophylaxis Autoimmune Thyroiditis Infective Complication Prophylactic Antibiotic Treatment Hibitane
clean surgical procedures (incidence of infections < 5%);
clean – contaminated surgical procedures (incidence of infections < 10%);
contaminated surgical procedures (incidence of infections about 20%);
dirty surgical procedures (incidence of infections about 40%).
Thyroidectomy is classified amongst clean surgical procedures, those where there is no intra-operatory bacterial contamination following surgery. Post-operatory wound infections are a very uncommon finding after thyroidectomy. For these reasons international guidelines do not routinely recommend systemic antibiotic prophylaxis . Although many different guidelines of the National Health Service and of Surgical Societies include these recommendations, systemic antibiotic prophylaxis is nonetheless frequently used in thyroid surgery. According to the majority of surgeons, this conduct is justified with the potential risk of infections related to the positioning of drains. The benefits of this antibiotic prophylaxis are not supported by clinical evidence in the literature.
We have conducted a multicentric randomized double-blind study on 500 patients who had undergone thyroidectomy for goitre or thyroid carcinoma. The endpoint of this study was to evaluate the benefits of antibiotic prophylaxis vs. no prophylaxis in patients undergoing thyroid surgery.
Between January 2007 and June 2007 a multicentric randomised double blind study was conducted on 500 consecutive patients admitted to our clinical wards.
men or women between age 16 and 80;
absence of concomitant metabolic (diabetes), infective or hematologic pathologies;
absence of cardiac valvular pathologies;
patients not undergoing corticosteroid or immunosuppressive treatment;
patients in whom an aspirating drain had been positioned.
patients younger than 16 years and older than 80;
presence of concomitant metabolic (diabetes), infective and hematologic pathologies;
presence of severe obesity;
ongoing corticosteroid or immunosuppressive treatment;
presence of concomitant neoplasms;
patients undergoing thyroidectomy and lymphadenectomy;
patients undergoing secondary surgery in the cervical region;
patients undergoing thyroidectomy for locally advanced tumours;
patients undergoing thyroidectomy for autoimmune thyroiditis or Plummer adenoma;
patients with goitres submerged in the thorax;
patients without cervical drain.
Eligible patients were proposed to enter the RCT study upon acquisition of adequate informed consent. All patients underwent a minimum ambulatory follow up of 30 days.
The 500 patients enrolled in this multicentric trial (mean age 47 years) were randomized in two subgroups of 250 patients. The sequence allocation generation has been formulated by a researcher of another Institution through random numbers generated by a computer; the sequence allocation concealment was actuated by means of an e-mail sent by the researcher right after enrolling the patient in the study. 250 patients were treated with standard antibiotic prophylaxis with Unasyn (sulbactam/ampicillin) 1 fl (3 gr.) 30 min before surgery. No antibiotic prophylaxis was instituted in the remaining 250 patients.
Antiseptic and aseptic measures were standardized: disinfection by means of Betadine or Hibitane (a disinfectant that does not contain iodine and that is utilized in thyroid neoplasms to avoid false results at the control scintigraphy) followed by the placement of a sterile adhesive transparent cervical film. Hemostasis was very accurate. Absorbable hemostatics (Tabotamp by Ethicon or Floseal by Baxter) were never utilized intentionally for greater homogeneity of the two subgroups. The reconstructive surgical technique was also standardized again with the intent of making the two subgroups as homogeneous as possible. Platisma reconstruction and dermal approximation was obtained with simple interrupted sutures; the skin wound was closed with metallic staples. Wounds were always dressed every third day. As a rule drains were removed on the first postoperative day; when more than 80 cc of serum was collected, the drains were left in and removed in the following days according to the clinical judgement. Within each group of patients, two subgroups were highlighted: the subgroup of patients in whom the drains were removed in the first postoperative day and the subgroup of patients in whom it was necessary to keep the drains for a longer period of time (> 1 day). The statistical analysis of the data was carried out using Review Manager 5 .
Thyroid surgery is classified as a clean procedure and is associated with a low incidence of wound infections. (0,3%) . Although the majority of international guidelines do not recommend the use of systemic prophylactic antibiotic treatment, this practice is adopted sporadically in some nations and routinely in others . An audit carried out by the British Association of Endocrine Surgery (BAES) in England and Ireland showed that 9% of patients received routine antibiotic prophylaxis, 16% in selected cases and 75% did not receive it . In an Italian retrospective study carried out by Rosato on 14.394 patients, it was evidenced that 50% of surgeons use antibiotic prophylaxis, 17% antibiotic therapy and 33% neither prophylaxis nor therapy . The Scottish Intercollegiate Guidelines network (SIGN) does not advocate antibiotic prophylaxis for benign pathologies regarding it an opportunity to be reserved for selected cases of malignancies . The BAES and the Royal College of Physicians Thyroid Cancer do not list antibiotic prophylaxis amongst the recommendations to follow for thyroidectomy [8, 9]. Antibiotic prophylaxis does not ward off the development of infective complications of the surgical wound . The occurrence of severe cervical infections after thyroid surgery is an extremely rare event with an extremely high inherent mortality rate; however the occurrence of these infections, often cellulites with fulminating Streptococcal sepsis cannot be avoided with antibiotic prophylaxis .
In common clinical practice it is believed that the use of drains after thyroidectomy represents a risk factor for the development of infective complications of the surgical wound. This notion is not supported by clinical data, whereas conflicting evidence was presented recently in a systematic review by Samraj e Gurusamy . This review of the literature has evidenced 5 RCT in which 337 patients with drains were compared with 350 patients without drains following thyroidectomy; the statistical analysis failed to evidence that patients with drains show a significant incidence of infections of the surgical wound (P = 0,41). Therefore antibiotic prophylaxis does not seem to be beneficial in all patients with drains .
Our RCT showed that prophylactic antibiotic treatment is not beneficial in patients younger than eighty years old, with no concomitant metabolic, infective or hematologic disease, with no cardiac valvulopathies, not receiving steroidal or immunosuppressive treatment, and not severely obese. Thyroidectomies with associated lymphadenectomy, secondary surgery, excision of locally advanced disease, or of autoimmune thyroiditis and Plummer adenoma were excluded from this analysis. Drains did not represent a risk factor for the development of infections of the surgical wound even in the group of patients not undergoing antibiotic prophylaxis. Our study should be regarded only as a preliminary RCT, and should be followed by a study in which a larger number of patients should be enrolled so that statistically significant data can be obtained.
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