NCT03595852

Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

Preoperative Antibiotic Prophylaxis Versus Placebo in Clean, Non-prosthetic Surgery at CHUK. Impact on Surgical Site Infections and Patient Cost.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: University of Rwanda · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	Cefazolin	Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery
DRUG	Placebos	IV normal saline will be given to patients 30-60 minutes prior to incision

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-09-01
• Completion: 2019-03-15
• First posted: 2018-07-23
• Last updated: 2019-09-04

Locations

1 site across 1 country: Rwanda