Clinical trial NCT03595852: Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection
Official title: Preoperative Antibiotic Prophylaxis Versus Placebo in Clean, Non-prosthetic Surgery at CHUK. Impact on Surgical Site Infections and Patient Cost.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Site Infection
Lead sponsor: University of Rwanda
Sponsor class: OTHER
First posted: 2018-07-23
Enrollment: 138
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: antibiotic prophylaxis versus placebo in clean non prosthetic surgery. impact on surgical site infection and patient cost.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Surgical site infection
timeFrame: 30 days post operative
Secondary outcomes:
measure: mortality
timeFrame: 48 hours post operation
measure: morbidity
timeFrame: 48 hours post operation
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Kigali University Teaching Hospital (Chuk)
Study officials:
affiliation: fostino21@yahoo.fr
name: FAUSTIN NTIRENGANYA, MMed, FCS
role: STUDY_DIRECTOR
References: