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.: PACTR201606001689132 Date of Approval: 21/06/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Unblinded randomized control trial on Prophylactic Antibiotic Use in Gustilo II Open Tibia Fractures at Kenyatta National Hospital, Kenya
Official scientific title Unblinded randomized control trial on Prophylactic Antibiotic Use in Gustilo II Open Tibia Fractures at Kenyatta National Hospital, Kenya
Brief summary describing the background and objectives of the trial Background: Open fractures have been a challenge to clinicians for centuries and this scenario persists in the 21st century. Management protocols have been devised over the years including among others prophylactic antibiotic use (PAU). Optimum duration of antibiotic use has been extensively researched but still remains unresolved although most studies have recommended 24 to 72 hours of prophylaxis. Furthermore, no protocol exists on PAU in our set up and most clinicians prescribe for five days to several weeks. Therefore, there is need for further research in the quest to improve the effectiveness of prophylactic antibiotic use and its adoption in developing countries like Kenya. Objective: To determine the difference in infection rate between 24 hours versus five days of prophylactic antibiotic use in management of Gustilo II open tibia fractures. Design: Unblinded randomized control trial.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Musculoskeletal Diseases,Open fractures
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 29/09/2014
Actual trial start date 29/09/2014
Anticipated date of last follow up 30/03/2015
Actual Last follow-up date 30/03/2015
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 84
Recruitment status Completed
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
Parallel: different groups receive different interventions at same time during study Randomised Block randomization was used to allocate patients to one of the two arms of treatment. A list of random numbers were then computer-generated and the numbers between 1 and 6 selected until a total of 21 random numbers were obtained. The blocks were assigned to the random numbers to obtain an allocation sequence which was used to allocate patients to the two different treatments. NOT BLINDED Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group 24-HOUR GROUP CEFUROXIME 750MG TDS AND GENTAMYCIN 240MG 24 HOURS ANTIBIOTIC PROPHYLAXIS 42
Control Group 5-DAY GROUP CEFUROXIME 750MG TDS AND GENTAMYCIN 240MG OD 5 DAYS ANTIBIOTIC PROPHYLAXIS 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿Patients with isolated Gustilo grade II open tibial fractures. ¿Patients aged between 18 and 80 years. Pediatric patients were excluded because of fixed dosage regimen in the study protocol. ¿ Gustilo II open tibial fractures whose wounds could not be closed primarily after debridement ¿ Fractures that were not debrided within 24 hours of injury ¿ Non ¿ traumatic open tibia fractures such as pathological fractures ¿ Cigarette smokers ¿Patient with diabetes mellitus, HIV/AIDS, psychosis or chronic renal failure ¿Patients on corticosteroids or chemotherapy ¿Patients referred from other medical facilities where they had already received any form of treatment ¿Hemodynamically unstable patients ¿Patients who refused to give consent 18 Year(s) 80 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 10/09/2014 KNH/UON ERC
Ethics Committee Address
Street address City Postal code Country
HOSPITAL ROAD NAIROBI 00202 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome INFECTION Presence of infection at days 2, 5 and 14.
Secondary Outcome Effect of duration to antibiotic administration on infectionj rate hours to first antibiotic dose
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
KENYATTA NATIONAL HOSPITAL HOPSITAL ROAD NAIROBI 00202 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
PRINCIPAL INVESTIGATOR UON/KNH - HOSPTAL ROAD NAIROBI 00202 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor JOSHUA N ONDARI HOPSITAL ROAD NAIROBI 00202 Kenya University
COLLABORATORS
Name Street address City Postal code Country
PROF JEO ATINGA HOPSITAL ROAD NAIROBI 00202 Kenya
DR RICHARD OMBACHI HOPSITAL ROAD NAIROBI 00202 Kenya
MOSES MASIKA HOPSITAL ROAD NAIROBI 00202 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator JOSHUA ONDARI jondari59@gmail.com +254722686298 HOPSPITAL ROAD
City Postal code Country Position/Affiliation
NAIROBI 00202 Kenya UNIVERSITY OF NAIROBI
Role Name Email Phone Street address
Public Enquiries JOSHUA ONDARI jondari59@gmail.com +254722686298 HOSPITAL ROAD
City Postal code Country Position/Affiliation
NAIROBI 00202 Kenya UNIVERSITY OF NAIROBI
Role Name Email Phone Street address
Public Enquiries MOSES MASIKA mosmasika@gmail.com +254737770306 HOSPITAL ROAD
City Postal code Country Position/Affiliation
NAIROBI 00202 Kenya UNIVERSITY OF NAIROBI
Role Name Email Phone Street address
Scientific Enquiries RICHARD OMBACHI ombachirb@gmail.com +254722524948 HOPSPITAL ROAD
City Postal code Country Position/Affiliation
NAIROBI 00202 Kenya UNIVERSITY OF NAIROBI
Role Name Email Phone Street address
Scientific Enquiries MOSES MASIKA mosmasika@gmail.com +254737770306 HOPSPITAL ROAD
City Postal code Country Position/Affiliation
NAIROBI 00202 Kenya UNIVERSITY OF NAIROBI
Role Name Email Phone Street address
Scientific Enquiries JOHN ATINGA atinga08@gmail.com +254733737769 HOPSPITAL ROAD
City Postal code Country Position/Affiliation
NAIROBI 00202 Kenya UNIVERSITY OF NAIROBI
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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