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

Surgical Site Infection Clinical Trial

— SSI2  

Official title:

Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00801099
• Other study ID #: SSII
• Status: Completed
• Phase: N/A
• First received: November 6, 2008
• Last updated: July 16, 2015
• Start date: December 2004
• Est. completion date: March 2005

Study information

• Verified date: July 2015
• Source: Swiss Tropical & Public Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: EthikkommissionTanzania: National Institute for Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• surgical patient

• clean or clean-contaminated surgery

Exclusion Criteria:

• infection

• preoperative antibiotic treatment

• postoperative antibiotic treatment

• open fractures

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Amoxicillin/Clavulanic Acid
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

Locations

Country	Name	City	State
Switzerland	Swiss Tropical Institute	Basel	BS

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Tropical & Public Health Institute	Swiss Academy of Medical Sciences (SAMS)

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Saxer F, Widmer A, Fehr J, Soka I, Kibatala P, Urassa H, Frei R, Smith T, Hatz C. Benefit of a single preoperative dose of antibiotics in a sub-saharan district hospital: minimal input, massive impact. Ann Surg. 2009 Feb;249(2):322-6. doi: 10.1097/SLA.0b0 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Surgical Site Infections		within 30 days postoperative	No
Secondary	Sustainability of the Intervention in This Setting		during 3 month of study phase	Yes