| CTRI Number |
CTRI/2018/11/016410 [Registered on: 26/11/2018] Trial Registered Prospectively |
| Last Modified On: |
04/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The benefit of a solution in control of infection at pin insertion site after bone operation. |
|
Scientific Title of Study
|
A randomized trial to assess the effectiveness of intervention protocol in prevention and control of pin site infection among orthopedic patients with external fixator admitted in PDVVPs Memorial hospital, Ahmednagar, Maharashtra. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AMOL C TEMKAR |
| Designation |
Lecturer |
| Affiliation |
Dr VVPFS Ahmednagar |
| Address |
Dr VVPFs College Of Nursing Vilad Ghat
Ahmednagar
Dr V V P Fs Memorial Hospital Staff Quarter Block A 6
Vilad Ghat
Ahmednagar
414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890787219 |
| Fax |
|
| Email |
amoltemkar09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amol C Temkar |
| Designation |
Lecturer |
| Affiliation |
Dr VVPFS Ahmednagar |
| Address |
Dr VVPFs College Of Nursing Vilad Ghat
Ahmednagar
Dr VVPFS Meorial Hospital Staff Quarter Block A 6
Vilad Ghat
Ahmednagar
414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9890787219 |
| Fax |
|
| Email |
amoltemkar09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepak Naikwade |
| Designation |
Professor in Orthopedics |
| Affiliation |
Dr VVP Foundation |
| Address |
Dr VVPFs Memorial Hospital
Vilad Ghat
Ahmednagar
Dr VVPFs Memorial Hospitals Staff Quarter Block C 11
Vilad Ghat
Ahmednagar
414111
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8888941671 |
| Fax |
|
| Email |
deepak_naikwade@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Registrar
Maharashtra University of Health Sciences Nashik General Fund
Mhasarul
Dindori Road
Nashik
422004 |
|
|
Primary Sponsor
|
| Name |
Dr VVPFs Memorial Hospital |
| Address |
Vilad Ghat
Ahmednagar |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MUHS Nashik |
Mhasrul
Vani Dindori Road
Nashik
422004 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Deepak Naikwade |
Dr VVPFs Memorial Hospital Ahmednagar |
Orthopaedic Department
Room No 2
Word No 19
Dr VVPFs Memorial Hospital Ahmednagar
Vilad Ghat
Ahmednagar
Ahmadnagar
MAHARASHTRA |
8888941671
deepak_naikwade@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PDVVPFS College of Nursing Education Ahmednagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local application of betadine |
Application of betadine as a cleansing agent for pin insertion site care after orthopedic surgery in patients with external metal fixator around three times a week for 3 weeks |
| Intervention |
Local application of chlorhexidine |
Application of chlorhexidine as a cleansing agent for pin insertion site care after orthopedic surgery in patients with external metal fixator around three times a week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient with external metal fixator
2 Patient who will be able to follow instruction
3 Patient with single orthopedic injury
4 Patient with multiple orthopedic injuries |
|
| ExclusionCriteria |
| Details |
1 Patient with chronic diseases like DM, HTN
2 Patient with systemic infection after diagnostic test
3 Patient with previous pin insertion site infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of Infection at pin insertion site |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved wound condition |
15 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
04/02/2019 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet Published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Objectives of the study: 1 To assess the effectiveness of intervention protocol in prevention and control of pin site infection among orthopedic patient with external fixator. 2 To find the association between the effect of intervention protocol in prevention and control of pin site infection among orthopedic patients with external fixator and selected demographic variables Hypothesis of the study: There will be a significant association between intervention protocol and pin site infection among orthopedic patients with external fixator The study will be based on the theoritical framework of Health Belief Model. Trial will be analysed through descriptive and inferential statistics. |