Double blind randomized controlled trial for subjects undergoing surgery receiving surgical antimicrobial prophylaxis at tertiary hospital: the clinical pharmacist’s interventions

Abstract

Background: A surgical site infection (SSI) has significant clinical, humanistic and economic consequences. Surgical antimicrobials prophylaxis (SAP) is a reliable standard to prevent SSIs. Objective: The objective was to test that the clinical pharmacist's interventions may facilitate the implementation of SAP protocol and subsequent reduction of SSIs. Methods: This was double blinded randomized controlled interventional hospital-based-study at Khartoum State-Sudan. A total of 226 subjects underwent general surgeries at four surgical units. Subjects were randomized to interventions and controls in a (1:1) ratio where patient, assessors and physician were blinded. The surgical team has received structured educational and behavioral SAP protocol mini courses by way of directed lecturers, workshops, seminars and awareness campaigns delivered by the clinical pharmacist. The clinical pharmacist provided SAP protocol to the interventions group. The outcome measure was the primary reduction in SSIs. Results: There were (51.8%, 117/226) females, (61/113 interventions versus 56/113 controls), and (48.2%, 109/226) males (52 interventions and 57 controls). The overall rate of SSIs was assessed during 14 days post-operatively and was documented in (35.4%, 80/226). The difference in adherence to locally developed SAP protocol regarding the recommended antimicrobial was significant (P <0.001) between the interventions group (78, 69%) and the controls group (59, 52.2%). The clinical pharmacist's implementation of the SAP protocol revealed significant differences in SSIs with reduction in SSIs from 42.5% to 25.7% versus the controls group from 57.5% to 44.2% respectively, P = 0.001 between the interventions group and the controls group respectively. Conclusion: The clinical pharmacist's interventions were very effective in sustainable adherence to SAP protocol and subsequent reduction in SSIs within the interventions group.