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

NCT ID: NCT00801099

Last Updated: 2015-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2005-03-31

Brief Summary

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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

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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.

Conditions

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Surgical Site Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Abx

single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

Group Type EXPERIMENTAL

Amoxicillin/Clavulanic Acid

Intervention Type DRUG

single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

Interventions

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Amoxicillin/Clavulanic Acid

single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively

Intervention Type DRUG

Other Intervention Names

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Augmentin

Eligibility Criteria

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Inclusion Criteria

* surgical patient
* clean or clean-contaminated surgery

Exclusion Criteria

* infection
* preoperative antibiotic treatment
* postoperative antibiotic treatment
* open fractures
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss Academy of Medical Sciences (SAMS)

OTHER

Sponsor Role collaborator

Swiss Tropical & Public Health Institute

OTHER

Sponsor Role lead

Responsible Party

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Department of Medicine and Diagnostics, Swiss Tropical Institute

Principal Investigators

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Christioph F Hatz, MD

Role: STUDY_CHAIR

Swiss Tropical & Public Health Institute

Locations

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Swiss Tropical Institute

Basel, Canton of Basel-City, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type RESULT
PMID: 19212189 (View on PubMed)

Other Identifiers

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SSII

Identifier Type: -

Identifier Source: org_study_id

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