Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections (SSI2)

This study has been completed.
Sponsor:
Collaborator:
Swiss Academy of Medical Sciences (SAMS)
Information provided by:
Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier:
NCT00801099
First received: November 6, 2008
Last updated: January 13, 2009
Last verified: December 2008

November 6, 2008
January 13, 2009
December 2004
March 2005   (final data collection date for primary outcome measure)
Number of Participants With Surgical Site Infections [ Time Frame: within 30 days postoperative ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00801099 on ClinicalTrials.gov Archive Site
Sustainability of the Intervention in This Setting [ Time Frame: during 3 month of study phase ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections
Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Surgical Site Infection
Drug: Amoxicillin/Clavulanic Acid
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Other Name: Augmentin
Experimental: Abx
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Intervention: Drug: Amoxicillin/Clavulanic Acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
March 2005
March 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • surgical patient
  • clean or clean-contaminated surgery

Exclusion Criteria:

  • infection
  • preoperative antibiotic treatment
  • postoperative antibiotic treatment
  • open fractures
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00801099
SSII
No
Prof. Dr. med. C. Hatz, Department of Medicine and Diagnostics, Swiss Tropical Institute
Swiss Tropical & Public Health Institute
Swiss Academy of Medical Sciences (SAMS)
Study Chair: Christioph F Hatz, MD Swiss Tropical & Public Health Institute
Swiss Tropical & Public Health Institute
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP