Phase 3 Study of Antibiotic Prophylaxis Use Prior Emergent Surgery, Because of Acute Appendicitis

Introduction Infection related to surgical procedure was always considered the main cause of mortality end morbidity in surgical patients. ATB prophylaxis has become the breakthrough in surgical praxis in terms of prevention of surgical postoperative complications (Surgical Site Infection - SSI) and radical improvement of surgical results. ATB prophylaxis prior to intervention procedures presents however 1/3 of costs for medicinal products and it is also potentially hazardous. Even single use of antibiotic agent can be a cause for development of nosocomial infection with indispensable mortality and costly treatment. Several recommendation in worldwide literature have been presented during the last 10 years which concerned indications and route of administration of antibiotics prior to scheduled or acute surgical procedure; indications for acute procedures broaden and it increases the consumption of antibiotics. Excessive pre-hospital and hospital exposure to antibiotics is however related to development of microbial resistance which shows in higher incidence of nosocomial infections (health care - associated infection - HAI) - urinary infections, pneumonia, catheter infection and another diseases such as Clostridium colitis caused by highly virulent type. Moreover some studies suggest bad compliance in dosing and timing of antibiotic prophylaxis which causes only the negative effect of prophylaxis without positive affection of SSI. This knowledge and disagreement led us to elaboration of protocol for prospective randomized placebo controlled study which could be the base for correct surgical praxis in investigator's conditions.

Aim of the project The aim of this prospective randomized placebo controlled study is to prove the positive effect of antibiotic prophylaxis on the incidence of SSI in patients with comparable risk of developing other nosocomial infections in case of acute abdominal procedures for diagnosis such as appendicitis, ileus of small bowel and stomach or small bowel perforation and thus with exclusion of tertiary peritonitis. Secondary aim is to identify the group of patients in which risk of developing nosocomial infection exceeds benefit of ATB prophylaxis. Tertiary aim is to assess whether preoperative microbial screening has its significance for reduction of HAI. After comparing the financial cost of therapy (including SSI and HAI generally) it will be possible to submit background for proposal of recommended procedure for administration of antibiotic prophylaxis in the most common acute surgical procedures with regard to risk factors for genesis of nosocomial infections. Such prospective randomized placebo controlled study has not been conducted in the Czech Republic; further study with similar target group of patients (very common in surgical praxis) has not been published in world literature.

Hypothesis Correctly administered antibiotic prophylaxis prior to acute abdominal procedures reduces frequency of SSI. It can increase the frequency of severe nosocomial infections in risk group of patients. rational use of antibiotic prophylaxis should however lead to reduction of incidence of nosocomial infections with clinical and socioeconomic impacts including prevention of feared severe infections associated with health care (HAI).

Methodology

Method is aimed at: