Surgical Site Infection Clinical Trial
Official title:
Preoperative Antibiotic Prophylaxis Versus Placebo in Clean, Non-prosthetic Surgery at CHUK. Impact on Surgical Site Infections and Patient Cost.
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.
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.
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