Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

University of Rwanda

Status: Completed

Conditions: Surgical Site Infection

Treatments: Drug: Cefazolin; Drug: Placebos

Study type: Interventional

Funder types: Other

Identifiers

NCT03595852

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Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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138 participants in 2 patient groups, including a placebo group

Prophylaxis

Experimental group

Description:

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.

Treatment:

Drug: Cefazolin

No prophylaxis

Placebo Comparator group

Description:

The control group will receive a similarly looking prepared placebo injection (normal saline placebos for injection) 30-60 minutes prior to incision.

Treatment:

Drug: Placebos