Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

Not Applicable

Completed

• Conditions: Surgical Site Infection
• Interventions: Drug: Placebos; Drug: Cefazolin

• Registration Number: NCT03595852
• Lead Sponsor: University of Rwanda

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.

Study Timeline

• Study First Submitted: 2017-08-03
• Study Start: 2018-03-01
• Study First Submitted QC: 2018-07-12
• Study First Posted: 2018-07-23
• Primary Completion: 2018-09-01
• Study Completion: 2019-03-15
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-01
• Last Update Posted: 2019-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No prophylaxis	Placebos	The control group will receive a similarly looking prepared placebo injection (normal saline placebos for injection) 30-60 minutes prior to incision.
Prophylaxis	Cefazolin	The intervention will be a single dose of prophylactic antibiotic (cefazolin): 2 gr in adults or 3 gr for patients weighing \>120Kg or 30mg/kg in children given within 30-60 minutes prior to skin incision.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Kigali University Teaching Hospital (Chuk); 🇷🇼 Kigali, Rwanda