Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Amoxicillin/Clavulanic Acid

• Registration Number: NCT00801099
• Lead Sponsor: Swiss Tropical & Public Health Institute

Brief Summary

In a rural hospital in Tanzania the rate of surgical site infections (SSI) was 21.6%. Inappropriate choice of antibiotics and of administration time were determined as sole risk factors in this setting. After implementation of a standardized procedure with a single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively the rate of SSI dropped by 80% in spite of procedural risk factors like poor hygiene etc.

Detailed Description

Surgical Site Infections (SSIs) have an important socioeconomic impact prolonging the period of hospitalization and rehabilitation. Patients with SSIs are five times more likely to be readmitted and are even twice as likely to die compared to patients with similar interventions without SSI. In non-industrialized countries, the incidence of SSIs is higher and the consequences of SSI are even more severe: Many hospitals lack appropriate facilities for early diagnosis and treatment. In addition, microbiological identification of pathogens and susceptibility testing are rarely available, a prerequisite for targeted treatment of SSIs. Overcrowding and understaffing are additional risk factors for SSIs, common in these countries.

A study conducted at the local surgeons' suggestion in an 82-bed department of general surgery, obstetrics and gynecology, urology and orthopedics at the St. Francis Designated District Hospital (SFDDH) in Ifakara (Southern Tanzania) showed an SSI-rate of 21.6%.

The analyses of this study identified two major risk factors for SSI in clean and clean-contaminated surgical procedures: Inadequate timing of administration of routine antimicrobial prophylaxis (AMP) and inappropriate selection of antibiotics not covering the most commonly observed pathogens.

Therefore, an intervention study was discussed with the local surgeon in charge to improve selection and timing of routine AMP and thereby reduce the rate of SSIs.

The study design and objective were presented to all the staff during a general meeting and special duties and responsibilities discussed with the individual colleagues. Furthermore we distributed pocket flow sheets to the involved staff and hung up some laminated flow sheets in theatre.

Study Timeline

• Study Start: 2004-12
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Study First Submitted: 2008-11-06
• Results First Submitted: 2008-11-06
• Study First Submitted QC: 2008-12-02
• Results First Submitted QC: 2008-12-02
• Study First Posted: 2008-12-03
• Results First Posted: 2008-12-03
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-16
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• surgical patient
• clean or clean-contaminated surgery

Exclusion Criteria

• infection
• preoperative antibiotic treatment
• postoperative antibiotic treatment
• open fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Abx	Amoxicillin/Clavulanic Acid	single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

Primary Outcome Measures

Name	Time	Method
Number of Participants With Surgical Site Infections	within 30 days postoperative

Secondary Outcome Measures

Name	Time	Method
Sustainability of the Intervention in This Setting	during 3 month of study phase

Trial Locations

Locations (1)

Swiss Tropical Institute; 🇨🇭 Basel, BS, Switzerland