| CTRI Number |
CTRI/2020/05/025287 [Registered on: 21/05/2020] Trial Registered Prospectively |
| Last Modified On: |
18/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Dressing Technique with Topical Antibiotic Solution and Saline ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two dressing techniques used for Pin site Dressing in patients on Linear External Fixators applied for Fractures.
|
|
Scientific Title of Study
|
"Efficacy of Saline dressing Vs Povidone Iodine dressing in preventing pin site infection in patients on linear external fixators- A Randomized Controlled Trial" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrRavishankar J |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Orthopedics,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442399120 |
| Fax |
|
| Email |
ravishankarhealthcare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deep Sharma |
| Designation |
Additional Professor and Head |
| Affiliation |
JIPMER |
| Address |
Department of Orthopedics,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9489146554 |
| Fax |
|
| Email |
drdeep_sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrRavishankar J |
| Designation |
Junior Resident |
| Affiliation |
JIPMER |
| Address |
Department of Orthopedics,
JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9442399120 |
| Fax |
|
| Email |
ravishankarhealthcare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthopedics ,
Jawaharlal Institute of Post Graduate Medical Education and Research, Puducherry |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
JIPMER,
Puducherry |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrRavishankar J |
JIPMER Hospital |
Department of Orthopedics ,
PMRC Block,
Puducherry.
Pondicherry
PONDICHERRY |
9442399120
ravishankarhealthcare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR INTERVENTIONAL STUDIES-JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
Povidone Iodine Dressing |
Povidone Iodine Dressing is applied to the Schanz Pin based on Computer Generated Random Sequence |
| Intervention |
Saline dressing |
Saline Dressing is applied to the Schanz pin ,based on computer generated Random Sequence |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients in whom Schanz pins (Linear External Fixator) have been applied in JIPMER |
|
| ExclusionCriteria |
| Details |
1.Patient or their caregivers who cannot understand the therapeutic method of dressing during supervised dressing sessions,
2.Patients not willing for regular follow up , within the period of data collection ,
3.Known allergy to Iodine and known medical ailment where Iodine is contraindicated |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Infection Days rate in each patient |
1.5 years from start of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Infection Days rate in each patient |
1.5 years from the start of the study |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/05/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is done to test the Efficacy of saline dressing Vs Povidone iodine dressing to the pin sites in patients on Linear External Fixator , since there is no Consensus about the use of dressing type to the pins in the available literature, this study aims to provide Clarity upon the use of the two different dressing technique in the Schanz pin (linear external Fixator) |