Surgical Site Infection
Conditions
Brief summary
This is a randomized control study of antibiotic uses in clean non prosthetic surgeries. One group will be given antibiotic prophylaxis, other will receive a placebo. The primary outcome will be the rate of surgical site infection in 2 groups.
Detailed description
I will conduct a randomized controlled trial (RCT) of antibiotic prophylaxis versus placebo in clean, non-prosthetic, elective procedures. The intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing \>120Kg and 30mg/kg in children) within 30-60 minutes prior to skin incision. The control group will receive a similarly prepared placebo injection (water for injection) 30-60 minutes prior to incision. I will randomize patients in a 1:1 allocation ratio using a simple randomization. Patients will randomly pick an envelope with a number allocating to antibiotic prophylaxis or placebo. Patients and caretakers will be blinded to the intervention. The surgeon will also be blinded to the intervention. The antibiotic (or placebo) will be pre-mixed by the study investigator and administered by the anesthetist. Other preventive measures for surgical site infection (SSIs) such as effective surgical hand scrub, proper skin preparation with povidone and sterility of materials and instrument will be applied systematically in all groups. Dressing of the wound will be removed 48 hours after operation and no further dressing will be required. Patients will be followed for development of SSI documented by surgeon at discharge and will be called after 30 days of surgery to address any sign of SSI.
Interventions
DRUGCefazolin
Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery
DRUGPlacebos
IV normal saline will be given to patients 30-60 minutes prior to incision
Sponsors
University of Rwanda
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)
Masking description
patients and investigator will be blinded for intervention
Intervention model description
antibiotic prophylaxis versus placebo in clean non prosthetic surgery. impact on surgical site infection and patient cost.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* \- All elective non-prosthetic surgical procedures such as hernia, thyroid, hydrocele, undescended testes surgery, removal of orthopedic implants, low risk breast surgical procedures and other all procedures deemed to be clean.
Exclusion criteria
* \- Emergency cases * Any patient with American Society of Anesthesiologists Score (ASA)\>2 * Procedures lasting more than 2 hours * Patients who were taking antibiotics 2 days prior to operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | 30 days post operative | surgical wounds will be accessed for signs of surgical site infection at discharge by a treating surgeon and patients will be called 30 days after operation for signs of surgical site infection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | 48 hours post operation | death |
| morbidity | 48 hours post operation | morbidity will be defined as any one of the following clinical diagnoses made by a treating surgeon: unplanned reoperation, healthcare associated infection, pneumonia, cardiac arrest, pulmonary embolism |
Countries
Rwanda
Outcome results
None listed