Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201406000803420 Date of Approval: 29/03/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Cefepime Vs. Ceftriaxone in orthopedics at Bugando
Official scientific title Cefepime Vs Ceftriaxone For Perioperative Systemic Antibiotic Prophylaxis In Elective Orthopedic Surgery At Bugando Medical Centre Mwanza Tanzania: A Randomized Clinical Study
Brief summary describing the background and objectives of the trial Surgical site infection (SSI) continues to be a major source of morbidity and mortality in developing and resource thin countries despite advances in aseptic techniques. Appropriate choice and use of antimicrobial surgery reduces the incidence of postoperative infections; especially among patients undergoing orthopedic implant surgery in which wound infection portend serious clinical outcomes. A surge in empirical use and abuse of Ceftriaxone and Cefepime trend high at Bugando Medical Center contrary to scientific guidelines and in the absence of a standard protocol.Yet, there is limited information available to contextually evaluate the effectiveness of these two drugs; deter over-use or halt their use in current practice. These circumstances prompts the aim of this study: to evaluate the efficacy and safety of cefepime and ceftriaxone as perioperative antimicrobial prophylaxis in elective orthopedic surgery at Bugando Medical Centre. More specifically elucidate the incidence of surgical site infections between the two groups,etiological agents responsible and effectiveness of a single dose perioperative prophylaxis will be determined.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Orthopedic Surgical Site Infections,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/06/2014
Actual trial start date 02/06/2014
Anticipated date of last follow up 05/01/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 230
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised subjects will be clustered into two groups with randomization done using a table from a statistics book Allocation of will be done by drawing sealed opaque envelopes-with replacement Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Intravenous Cefepime 2g Single Dose Infusion given 30 minutes before induction of Anesthesia or if surgery lasts more than 6hrs 115
Control Group Ceftriaxone 50mg/Kg Bwt Upto 2g Single Dose15 to 30 Minutes Pre-induction Infusion given 30 minutes before induction of Anesthesia or if surgery lasts more than 6 hrs or blood loss exceeding 2000mls 115 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.All patients undergoing elective orthopedic surgery at BMC during the study period 2.Patients who will consent to participate in the study 1. All patients with open contaminated fractures 2. Administration of any other antibiotic within the 7 days preceding surgery and/or at the time of surgery; 3.Known history of hypersensitivity to beta-lactams; 4.Renal insufficiency, immunodeficiency disorders, severe HIV infection, pregnancy and diabetes 5.Previous or preexisting infection of soft tissue, bone or at the site of the fracture 12 Month(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/03/2014 Joint CUHAS/BMC Research and Publications Committee
Ethics Committee Address
Street address City Postal code Country
Wuzburg Road Mwanza Tanzania
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Surgical Site Infection Day 3, 5, 7, 14, 30 Follow up will be done for a month in ward, and in case of discharge using telephone and outpatient scheduled encounters
Secondary Outcome None anticipated due to internal constraints Not planned to be measured
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Bugando Medical Center Wuzburg Road Mwanza Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Catholic University of Health and Allied Sciences Bugando Medical Center; Wuzburg Road Mwanza Tanzania
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Catholic University of Health and Allied Sciences Wuzburg Road Mwanza Tanzania University
COLLABORATORS
Name Street address City Postal code Country
Catholic University of Health and Allied Sciences Wuzburg Road Mwanza Tanzania
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Joel Marwa makengem@yahoo.com +255 688 232 972 wuzburg Road
City Postal code Country Position/Affiliation
Mwanza Tanzania Student Resident
Role Name Email Phone Street address
Public Enquiries Gilbert Kongola gkongola@yahoo.com +255 715 570 426 Bugando Medical Centre, Wuzburg Road
City Postal code Country Position/Affiliation
Mwanza Tanzania Director Research and Innovation
Role Name Email Phone Street address
Scientific Enquiries Stephen Mshana mshana72@bugando.ac.tz +255 787 302 028 Catholic University of Health Sciences, Wurzbur Rd,
City Postal code Country Position/Affiliation
Mwanza Tanzania Associate Professor in Microbiology/Immunology
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information