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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00801099
Recruitment Status : Completed
First Posted : December 3, 2008
Results First Posted : December 3, 2008
Last Update Posted : August 7, 2015
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Surgical Site Infection Drug: Amoxicillin/Clavulanic Acid

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 276 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact
Study Start Date : December 2004
Primary Completion Date : March 2005
Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Abx
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Drug: Amoxicillin/Clavulanic Acid
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Other Name: Augmentin

Outcome Measures

Primary Outcome Measures :
  1. Number of Participants With Surgical Site Infections [ Time Frame: within 30 days postoperative ]

Secondary Outcome Measures :
  1. Sustainability of the Intervention in This Setting [ Time Frame: during 3 month of study phase ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • surgical patient
  • clean or clean-contaminated surgery

Exclusion Criteria:

  • infection
  • preoperative antibiotic treatment
  • postoperative antibiotic treatment
  • open fractures
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00801099

Swiss Tropical Institute
Basel, BS, Switzerland, 4001
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Swiss Academy of Medical Sciences (SAMS)
Study Chair: Christioph F Hatz, MD Swiss Tropical & Public Health Institute
More Information

Responsible Party: Prof. Dr. med. C. Hatz, Department of Medicine and Diagnostics, Swiss Tropical Institute
ClinicalTrials.gov Identifier: NCT00801099     History of Changes
Other Study ID Numbers: SSII
First Posted: December 3, 2008    Key Record Dates
Results First Posted: December 3, 2008
Last Update Posted: August 7, 2015
Last Verified: July 2015

Keywords provided by Swiss Tropical & Public Health Institute:
Postoperative wound infection
surgical site infection
antimicrobial prophylaxis
developing countries
Sub-Saharan Africa
reduction of SSI using preoperative antibiotics

Additional relevant MeSH terms:
Communicable Diseases
Surgical Wound Infection
Wound Infection
Postoperative Complications
Pathologic Processes
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors