Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

138 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-15

Brief Summary

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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.

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Detailed Description

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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

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Surgical Site Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

antibiotic prophylaxis versus placebo in clean non prosthetic surgery. impact on surgical site infection and patient cost.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

patients and investigator will be blinded for intervention

Study Groups

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Prophylaxis

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.

Group Type EXPERIMENTAL

Cefazolin

Intervention Type DRUG

Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery

No prophylaxis

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

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

IV normal saline will be given to patients 30-60 minutes prior to incision

Interventions

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Cefazolin

Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery

Intervention Type DRUG

Placebos

IV normal saline will be given to patients 30-60 minutes prior to incision

Intervention Type DRUG

Other Intervention Names

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ancef saline

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No