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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
History of Changes
  Purpose

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
Surgical Site Infection
 Drug: Amoxicillin/Clavulanic Acid

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by Swiss Tropical & Public Health Institute:

Primary Outcome Measures:
  • Number of Participants With Surgical Site Infections [ Time Frame: within 30 days postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sustainability of the Intervention in This Setting [ Time Frame: during 3 month of study phase ] [ Designated as safety issue: Yes ]

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
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

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • surgical patient
  • clean or clean-contaminated surgery

Exclusion Criteria:

  • infection
  • preoperative antibiotic treatment
  • postoperative antibiotic treatment
  • open fractures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801099

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

No publications provided

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
Study First Received: November 6, 2008
Results First Received: November 6, 2008
Last Updated: January 13, 2009
Health Authority: Switzerland: Ethikkommission
Tanzania: National Institute for Medical Research

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:
Amoxicillin
Anti-Bacterial Agents
Clavulanic Acids
Clavulanic Acid
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013