Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

Surgical Site Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03595852
• Other study ID #: 1234
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: September 2019
• Source: University of Rwanda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: March 15, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Cefazolin
Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery
• Placebos
IV normal saline will be given to patients 30-60 minutes prior to incision

Locations

Country	Name	City	State
Rwanda	Kigali University Teaching Hospital (Chuk)	Kigali

Sponsors (1)

Lead Sponsor	Collaborator
University of Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	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	30 days post operative
Secondary	mortality	death	48 hours post operation
Secondary	morbidity	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	48 hours post operation