| CTRI Number |
CTRI/2018/02/011868 [Registered on: 13/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
08/02/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess the appropriateness of antibiotics used to prevent infection during surgery done for fracture and related financial burden on patients based on our national guidelines |
|
Scientific Title of Study
|
Evaluation of appropriateness and pharmacoeconomics of surgical antimicrobial prophylaxis in open reduction internal fixation surgery based on NCDC guidelines |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Kumari |
| Designation |
3rd year post graduate, Pharmacology |
| Affiliation |
Kempegowda Institute of Medical Sciences (KIMS) |
| Address |
Department of Pharmacology, KIMS college, Banashankari 2nd stage, Bengaluru, Karnataka, India, 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
9740512205 |
| Fax |
|
| Email |
dr_priyanka2009@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasundara K |
| Designation |
Professor, Department of Pharmacology |
| Affiliation |
Kempegowda Institute of Medical Sciences (KIMS) |
| Address |
Department of Pharmacology, KIMS college, Banashankari 2nd stage, Bengaluru, Karnataka, India, 56070
Bangalore
KARNATAKA
560070
India |
| Phone |
9480333963 |
| Fax |
|
| Email |
vasundarakrishnaiah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Kumari |
| Designation |
3rd year post graduate, Pharmacology |
| Affiliation |
Kempegowda Institute of Medical Sciences (KIMS) |
| Address |
Department of Pharmacology, KIMS college, Banashankari 2nd stage, Bengaluru, Karnataka, India, 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
9740512205 |
| Fax |
|
| Email |
dr_priyanka2009@yahoo.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KIMS hospital |
| Address |
VV puram, KR road, 560004 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanka Kumari |
KIMS hospital, Bengaluru |
Male, female and postoperative wards, Department of Orthopaedics
Bangalore
KARNATAKA |
9740512205
dr_priyanka2009@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee, KIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with closed fracture posted for open reduction internal fixation surgery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
closed fracture cases of more than 18 years of age, irrespective of gender, who were posted for ORIF surgery |
|
| ExclusionCriteria |
| Details |
Cases unwilling to give informed consent, open fracture, cases posted for delayed primary or secondary closure procedures, cases already receiving antimicrobials |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Superficial surgical site infection |
45th postoperative day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cost-analysis |
45th postoperative day |
|
|
Target Sample Size
|
Total Sample Size="303"
Sample Size from India="303"
Final Enrollment numbers achieved (Total)= "412"
Final Enrollment numbers achieved (India)="412" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2016 |
| Date of Study Completion (India) |
04/11/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not published yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Use of prophylactic antimicrobial, its preoperative frequency and route of administration was appropriate in all of the cases, however, selection of agent and dose administered was appropriate in only 13% of the cases. Duration of perioperative prophylaxis was not appropriate in any of the cases. Overall, none of the patients received completely appropriate surgical antimicrobial prophylaxis (SAP). The mean cost of SAP practiced in our hospital was ten times higher than that of SAP recommended by NCDC guidelines. |