|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201606001689132 |
|
Date of registration:
|
21/06/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Unblinded randomized control trial on Prophylactic Antibiotic Use in Gustilo II Open Tibia Fractures at Kenyatta National Hospital, Kenya
|
|
Scientific title:
|
Unblinded randomized control trial on Prophylactic Antibiotic Use in Gustilo II Open Tibia Fractures at Kenyatta National Hospital, Kenya |
|
Date of first enrolment:
|
29/09/2014 |
|
Target sample size:
|
84 |
|
Recruitment status: |
Complete |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1689 |
|
Study type:
|
Interventional |
|
Study design:
|
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
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
Kenya
| | | | | | | |
|
Contacts
|
|
Name:
|
JOSHUA
ONDARI |
|
Address:
|
HOSPITAL ROAD
00202
NAIROBI
Kenya |
|
Telephone:
|
+254722686298 |
|
Email:
|
jondari59@gmail.com |
|
Affiliation:
|
UNIVERSITY OF NAIROBI |
|
|
Name:
|
MOSES
MASIKA |
|
Address:
|
HOSPITAL ROAD
00202
NAIROBI
Kenya |
|
Telephone:
|
+254737770306 |
|
Email:
|
mosmasika@gmail.com |
|
Affiliation:
|
UNIVERSITY OF NAIROBI |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: ¿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.
Exclusion criteria: ¿ 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
Age minimum:
18 Year(s)
Age maximum:
80 Year(s)
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Open fractures
|
|
Musculoskeletal Diseases
|
Musculoskeletal Diseases
Open fractures
|
|
Intervention(s)
|
|
24-HOUR GROUP
|
|
5-DAY GROUP
|
|
|
|
Primary Outcome(s)
|
|
INFECTION
|
|
Secondary Outcome(s)
|
|
Effect of duration to antibiotic administration on infectionj rate
|
|
Source(s) of Monetary Support
|
|
PRINCIPAL INVESTIGATOR
|
|
Ethics review
|
Status: Approved
Approval date: 10/09/2014
Contact:
KNH/UON ERC
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|