Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

NCT03595852 | Completed DMC

• 1 other identifier: 1234
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• mortality

  48 hours post operation

• morbidity

  48 hours post operation

Study Arms (2)

Prophylaxis

EXPERIMENTAL

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.

Drug: Cefazolin

No prophylaxis

PLACEBO COMPARATOR

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

Drug: Placebos

Interventions

Cefazolin DRUG

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

Also known as: ancef

Prophylaxis

Placebos DRUG

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

Also known as: saline

No prophylaxis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University of Rwanda: lead

Study Sites (1)

Kigali University Teaching Hospital (Chuk)

Kigali, Rwanda

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Cefazolin; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• FAUSTIN NTIRENGANYA, MMed, FCS

  fostino21@yahoo.fr

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: patients and investigator will be blinded for intervention
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident in surgery

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

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: July 23, 2018
• Study Start: March 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: March 15, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

RW (1)