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Sponsors and Collaborators: |
Swiss Tropical Institute Swiss Academy of Medical Sciences (SAMS) |
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Information provided by: | Swiss Tropical Institute |
ClinicalTrials.gov Identifier: | NCT00801099 |
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.
Condition | Intervention |
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Surgical Site Infection |
Drug: Amoxicillin/Clavulanic Acid |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact |
Enrollment: | 276 |
Study Start Date: | December 2004 |
Study Completion Date: | March 2005 |
Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Abx: Experimental
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
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Drug: Amoxicillin/Clavulanic Acid
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
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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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland, BS | |
Swiss Tropical Institute | |
Basel, BS, Switzerland, 4001 |
Study Chair: | Christioph F Hatz, MD | Swiss Tropical Institute |
Responsible Party: | Department of Medicine and Diagnostics, Swiss Tropical Institute ( Prof. Dr. med. C. Hatz ) |
Study ID Numbers: | SSII |
Study First Received: | November 6, 2008 |
Results First Received: | November 6, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00801099 |
Health Authority: | Switzerland: Ethikkommission; Tanzania: National Institute for Medical Research |
Postoperative wound infection surgical site infection antimicrobial prophylaxis |
developing countries Sub-Saharan Africa reduction of SSI using preoperative antibiotics |
Amoxicillin Clavulanic Acid Clavulanic Acids |
Surgical Wound Infection Amoxicillin-Potassium Clavulanate Combination Wound Infection |
Anti-Infective Agents Anti-Bacterial Agents Communicable Diseases Molecular Mechanisms of Pharmacological Action |
Therapeutic Uses Enzyme Inhibitors Infection Pharmacologic Actions |