Surgical Site InfectionSSI2NCT00801099
Benefit of a Single Preoperative Dose of Antibiotics for the Prevention of Surgical Site Infections
A study testing Amoxicillin/Clavulanic Acid in people with Surgical Site Infection, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Surgical Site Infection
- What is being tested?
- Amoxicillin/Clavulanic Acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2004to Mar 2005
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- surgical patient
- clean or clean-contaminated surgery
Who cannot join
- infection
- preoperative antibiotic treatment
- postoperative antibiotic treatment
- open fractures
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Tropical Institute
Basel, Canton of Basel-City, 4001
About this study
Official title: Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact
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.
Read the 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.
- Conditions
- Surgical Site Infection
- Being tested
- Amoxicillin/Clavulanic Acid
- Keywords
- Postoperative wound infection, surgical site infection, antimicrobial prophylaxis, developing countries, Sub-Saharan Africa, reduction of SSI using preoperative antibiotics
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amoxicillin/Clavulanic AcidDrug
Also called Augmentin
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Abx | Experimental | single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively Receives: Drug: Amoxicillin/Clavulanic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Surgical Site Infections
Measured: within 30 days postoperative
Secondary outcomes (1)
Sustainability of the Intervention in This Setting
Measured: during 3 month of study phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startDec 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Surgical Site InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Academy of Medical Sciences (SAMS)
- Investigators
- Christioph F Hatz, MD, Study chair, Swiss Tropical & Public Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801099
- Sponsor's protocol ID
- SSII
- Acronym
- SSI2
- Status last verified
- Jul 2015
- First submitted
- 6 Nov 2008
- Last updated
- 7 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19212189
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact
- ClinicalTrials.gov ID
- NCT00801099
- Acronym / sponsor ID
- SSI2 / SSII
- Conditions
- Surgical Site Infection
- Keywords
- Postoperative wound infection, surgical site infection, antimicrobial prophylaxis, developing countries, Sub-Saharan Africa, reduction of SSI using preoperative antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Swiss Academy of Medical Sciences (SAMS)
- Study start
- Dec 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 3 Dec 2008 (estimated)
- Results
- Posted 3 Dec 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abx | Experimental | Drug: Amoxicillin/Clavulanic Acidsingle shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- surgical patient
- clean or clean-contaminated surgery
Key exclusion criteria (4 listed)
- infection
- preoperative antibiotic treatment
- postoperative antibiotic treatment
- open fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amoxicillin/Clavulanic AcidAlso: Augmentinsingle shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively | Drug | Abx |
Primary outcome
Number of Participants With Surgical Site Infections
Time frame: within 30 days postoperative
1 secondary outcome
Sustainability of the Intervention in This Setting
Time frame: during 3 month of study phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19212189Saxer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christioph F Hatz, MD study chair
Swiss Tropical & Public Health Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin/Clavulanic Acid in people with Surgical Site Infection, run by Swiss Tropical & Public Health Institute at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Dec 2008). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Surgical Site Infections (time frame: within 30 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801099, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.