NCT00801099

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2004

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 6, 2008

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
Same day until next milestone

Results Posted

Study results publicly available

December 3, 2008

Completed
Last Updated

August 7, 2015

Status Verified

July 1, 2015

Enrollment Period

3 months

First QC Date

November 6, 2008

Results QC Date

November 6, 2008

Last Update Submit

July 16, 2015

Conditions

Surgical Site Infection

Keywords

Postoperative wound infectionsurgical site infectionantimicrobial prophylaxisdeveloping countriesSub-Saharan Africareduction of SSI using preoperative antibiotics

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Surgical Site Infections

    within 30 days postoperative

Secondary Outcomes (1)

  • Sustainability of the Intervention in This Setting

    during 3 month of study phase

Study Arms (1)

Abx

EXPERIMENTAL

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

Drug: Amoxicillin/Clavulanic Acid

Interventions

Amoxicillin/Clavulanic AcidDRUG

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

Also known as: Augmentin
Abx

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • surgical patient
  • clean or clean-contaminated surgery

You may not qualify if:

  • infection
  • preoperative antibiotic treatment
  • postoperative antibiotic treatment
  • open fractures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swiss Tropical Institute

Basel, Canton of Basel-City, 4001, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 19212189RESULT

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Wound InfectionInfectionsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Results Point of Contact

Title
Franziska Saxer, MD
Organization
Swiss Tropical Institute
franziskabrenneke@yahoo.com

Study Officials

  • Christioph F Hatz, MD

    Swiss Tropical & Public Health Institute

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 6, 2008

First Posted

December 3, 2008

Study Start

December 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

August 7, 2015

Results First Posted

December 3, 2008

Record last verified: 2015-07

Locations

CH(1)