Background: Surgical site infections (SSI) are defined by The Centers for Disease Control and Prevention (CDC) as superficial or deep skin infections or an organ/space infection (1) and are one of the most common serious complications of surgery and anaesthesia (2). They are a leading cause of re-admissions, need for antibiotic treatment and general discomfort to the patient and they substantially increase the cost of care. Up to date, no prospective studies have assessed rates of SSI after gynaecological laparoscopies nor the influence of different solutions used to clean the skin on those rates.
Objective: To prospectively assess and compare the rate of SSI in gynaecological laparoscopies amongst three methods of skin preparation.
Methods: Included were patients undergoing an elective operative gynaecological laparoscopy aged 18 or above. Patients were randomized to three groups of skin preparation: (1) Abdominal preparation with Alcohol-based Chlorexidine solution and vaginal/vulvar preparation with Aqueous-based Chlorexidine solution; (2) Abdominal and vaginal/vulvar preparation with Aqueous-based Poviodine-Iodine solution; (3) Abdominal preparation with Alcohol-based Poviodine-Iodine solution and vaginal/vulvar preparation with Aqueous-based Poviodine-Iodine solution. To prevent confounding a standardised protocol of antibiotic treatment was applied. Patients were followed up by a doctor 1 and 4 weeks after surgery and evidence of infection according to CDC criteria was documented. The patient’s General Practitioners were asked to fill and send follow up forms in case an infection was diagnosed between the two follow-ups. The patient and the doctor performing the follow up were blinded to the method of skin preparation. Recruitment is ongoing and hence at this point we report overall infection rate and infection rate per coded groups without breaching blindness.
Results: Until now, 173 patients were recruited to the trial. Out of them, 83.3% had attended both follow up visits. Average age of participants was 36.8 years and average Body Mass Index was 27.3 kg/M2. The most common procedure was laparoscopy for treatment of endometriosis. The overall rate of SSI was 19%. 12.7% of patients were diagnosed with a superficial skin infection and 8.1% were diagnosed with organ/space infections. No deep skin infections were diagnosed. There was no significant difference between the groups in the rates of infections.
Conclusions: SSI after gynaecological laparoscopies appears to be a more common event than might be expected. Careful examination of port-sites is advised after laparoscopic surgery. To date, type of skin preparation solution has not been shown to affect rates of SSI.