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Antibiotic Prophylaxis in Clean Surgery. Impact on Surgical Site Infection

Sponsor
University of Rwanda (Other)
Overall Status
Completed
CT.gov ID
NCT03595852
Collaborator
(none)
138
Enrollment
1
Location
2
Arms
12.5
Actual Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
antibiotic prophylaxis versus placebo in clean non prosthetic surgery. impact on surgical site infection and patient cost.antibiotic prophylaxis versus placebo in clean non prosthetic surgery. impact on surgical site infection and patient cost.
Masking:
Double (Participant, Investigator)
Masking Description:
patients and investigator will be blinded for intervention
Primary Purpose:
Health Services Research
Official Title:
Preoperative Antibiotic Prophylaxis Versus Placebo in Clean, Non-prosthetic Surgery at CHUK. Impact on Surgical Site Infections and Patient Cost.
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Mar 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Cefazolin
Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery
Other Names:
  • ancef

    		•
    Placebo Comparator: No prophylaxis

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

    Drug: Placebos
    IV normal saline will be given to patients 30-60 minutes prior to incision
    Other Names:
  • saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Surgical site infection [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 Outcome Measures

    1. mortality [48 hours post operation]

      death

    2. morbidity [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kigali University Teaching Hospital (Chuk) Kigali Rwanda

    Sponsors and Collaborators

    • University of Rwanda

    Investigators

    • Study Director: FAUSTIN NTIRENGANYA, MMed, FCS, fostino21@yahoo.fr

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Isaie Sibomana, Resident in surgery, University of Rwanda
    ClinicalTrials.gov Identifier:
    NCT03595852
    Other Study ID Numbers:
    • 1234
    First Posted:
    Jul 23, 2018
    Last Update Posted:
    Sep 4, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Surgical Wound Infection
    Cefazolin

    Study Results

    No Results Posted as of Sep 4, 2019