Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections (SSI2)
Primary Purpose
Surgical Site Infection
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Amoxicillin/Clavulanic Acid
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infection focused on measuring Postoperative wound infection, surgical site infection, antimicrobial prophylaxis, developing countries, Sub-Saharan Africa, reduction of SSI using preoperative antibiotics
Eligibility Criteria
Inclusion Criteria:
- surgical patient
- clean or clean-contaminated surgery
Exclusion Criteria:
- infection
- preoperative antibiotic treatment
- postoperative antibiotic treatment
- open fractures
Sites / Locations
- Swiss Tropical Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Abx
Arm Description
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Outcomes
Primary Outcome Measures
Number of Participants With Surgical Site Infections
Secondary Outcome Measures
Sustainability of the Intervention in This Setting
Full Information
NCT ID
NCT00801099
First Posted
November 6, 2008
Last Updated
July 16, 2015
Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Swiss Academy of Medical Sciences (SAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00801099
Brief Title
Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections
Acronym
SSI2
Official Title
Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Swiss Tropical & Public Health Institute
Collaborators
Swiss Academy of Medical Sciences (SAMS)
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection
Keywords
Postoperative wound infection, surgical site infection, antimicrobial prophylaxis, developing countries, Sub-Saharan Africa, reduction of SSI using preoperative antibiotics
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
276 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abx
Arm Type
Experimental
Arm Description
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Intervention Type
Drug
Intervention Name(s)
Amoxicillin/Clavulanic Acid
Other Intervention Name(s)
Augmentin
Intervention Description
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Primary Outcome Measure Information:
Title
Number of Participants With Surgical Site Infections
Time Frame
within 30 days postoperative
Secondary Outcome Measure Information:
Title
Sustainability of the Intervention in This Setting
Time Frame
during 3 month of study phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
surgical patient
clean or clean-contaminated surgery
Exclusion Criteria:
infection
preoperative antibiotic treatment
postoperative antibiotic treatment
open fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christioph F Hatz, MD
Organizational Affiliation
Swiss Tropical & Public Health Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Swiss Tropical Institute
City
Basel
State/Province
BS
ZIP/Postal Code
4001
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19212189
Citation
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.0b013e31819782fd.
Results Reference
result
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Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections
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