Surgical Site Infection Clinical Trial
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04096885 -
The Inselspital Surgical Cohort Study
|
||
| Terminated |
NCT03820648 -
Wound Protector Dual-ring Alexis® in Pancreaticoduodenectomy
|
N/A | |
| Completed |
NCT04067843 -
Effect of Photodynamic Treatment on Skin Microbiome. Single Center Study
|
N/A | |
| Terminated |
NCT04042077 -
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections
|
Phase 3 | |
| Completed |
NCT05841576 -
Anaesthetic Management Guided by COMET Measurements
|
N/A | |
| Withdrawn |
NCT05338281 -
NPWT for Abdominal Incisions in DIEP Reconstructions: A RCT
|
N/A | |
| Recruiting |
NCT03042091 -
Neomycin and Metronidazole Hydrochloride With or Without Polyethylene Glycol in Reducing Infection in Patients Undergoing Elective Colorectal Surgery
|
Early Phase 1 | |
| Completed |
NCT01697748 -
Prospective Study on Cesarean Wound Outcomes
|
N/A | |
| Terminated |
NCT01789697 -
Text Message Study
|
N/A | |
| Recruiting |
NCT05966961 -
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
|
||
| Recruiting |
NCT05077592 -
Addition of Pre-wound Closure Povidone Iodine Wash Versus Direct Wound Closure Effect on Surgical Site Infections
|
Phase 4 | |
| Recruiting |
NCT05763602 -
PVI to Prevent S. Aureus SSI After Fixation of HELEF (POTENT Study)
|
Phase 4 | |
| Recruiting |
NCT05502380 -
Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery
|
Phase 3 | |
| Recruiting |
NCT03221023 -
Intrawound Vancomycin Prophylaxis for Neural Stimulator
|
Phase 2/Phase 3 | |
| Completed |
NCT03257202 -
Topical Treatment and Prevalence of P. Acnes
|
Phase 2 | |
| Completed |
NCT06154720 -
Surgical Site Infection After Episiotomy Repair Related to Routine Use of Antibiotic Prophylaxis in Low-Risk Population
|
||
| Not yet recruiting |
NCT06465901 -
A Stratified, Multi-ARm, muLti-site Randomised Platform Trial Aiming to Reduce the INcidence of Post-operative SSI
|
N/A | |
| Not yet recruiting |
NCT04820075 -
Efficacy of an Intervention to Improve the Preoperative Shower in Scheduled Surgery
|
N/A | |
| Recruiting |
NCT03561376 -
Zinc Oxide Versus Petrolatum Following Skin Surgery
|
Early Phase 1 | |
| Not yet recruiting |
NCT04496180 -
Prevena to Prevent Surgical Site Infection After Emergency Abdominal Laparotomy
|
N/A |