Skip to main content
OpenTrials
Completed

NCT Number: NCT03595852

Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Surgical Site Infection Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Wound Infection Wound Infection

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kigali University Teaching Hospital (Chuk)

Kigali, Rwanda

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin

Drug

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

Other names: ancef

Placebos

Drug

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

Other names: saline

Primary outcomes

  1. Surgical site infection

    Time frame: 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 outcomes

  1. mortality

    Time frame: 48 hours post operation

    death

  2. morbidity

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Rwanda

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.