Surgical Site Infection
Conditions
Keywords
Postoperative wound infection, surgical site infection, antimicrobial prophylaxis, developing countries, Sub-Saharan Africa, reduction of SSI using preoperative antibiotics
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.
Interventions
single shot dose of Amoxicillin/Clavulanic Acid approximately 30 min. preoperatively
Sponsors
Swiss Academy of Medical Sciences (SAMS)
Swiss Tropical & Public Health Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* surgical patient * clean or clean-contaminated surgery
Exclusion criteria
* infection * preoperative antibiotic treatment * postoperative antibiotic treatment * open fractures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Surgical Site Infections | within 30 days postoperative |
Secondary
| Measure | Time frame |
|---|---|
| Sustainability of the Intervention in This Setting | during 3 month of study phase |
Countries
Switzerland
Participant flow
Recruitment details
All consecutive patients older than 15 years admitted for clean or clean-contaminated (according to Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp.Epidemiol. 1999;20:250-78) interventions.
Participants by arm
| Arm | Count |
|---|---|
| Amoxicillin/Clavulanic Acid Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively. | 276 |
| Total | 276 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 101 |
Baseline characteristics
| Characteristic | Amoxicillin/Clavulanic Acid |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 13.9 |
| Region of Enrollment Tanzania | 276 participants |
| Sex: Female, Male Female | 230 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 276 |
| serious Total, serious adverse events | 11 / 276 |
Outcome results
Primary
Number of Participants With Surgical Site Infections
Time frame: within 30 days postoperative
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amoxicillin/Clavulanic Acid | Number of Participants With Surgical Site Infections | 11 participants |
Secondary
Sustainability of the Intervention in This Setting
Time frame: during 3 month of study phase