| CTRI Number |
CTRI/2024/03/064913 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare Thyroidectomy wound closure using subcuticular sutures with steristrips. |
|
Scientific Title of Study
|
A comparative study to evaluate the outcome of thyroidectomy wound closure using subcuticular sutures and steristrips. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ahmed Shameem T T |
| Designation |
General surgery resident |
| Affiliation |
Bangalore Medical College and Research institute, Bangalore |
| Address |
Sharavathi pg accomodation,
1st main, 1st cross,chamrajpet,
10th royal circle tippu sulthan palace road,
bangalore,
karnataka
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560018
India |
| Phone |
9995657697 |
| Fax |
|
| Email |
shameemt900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Rajkumar P N |
| Designation |
Professor |
| Affiliation |
Bangalore Medical College and Research institute, Bangalore |
| Address |
Department of General Surgery,
Bangalore Medical College and Research Institute
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9886655153 |
| Fax |
|
| Email |
dr.rajpn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ahmed Shameem T T |
| Designation |
General surgery resident |
| Affiliation |
Bangalore Medical College and Research institute, Bangalore |
| Address |
Sharavathi pg accomodation,
1st main, 1st cross,chamrajpet,
10th royal circle tippu sulthan palace road,
bangalore,
karnataka
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA
560018
India |
| Phone |
9995657697 |
| Fax |
|
| Email |
shameemt900@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical college and research institure, Bangalore
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka, India 560002 |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical college and research institute, Bangalore |
| Address |
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002 |
| 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 |
| DrAhmed shameem |
Bangalore medical college and research istitute, Bangalore |
Department of General Surgery,
Fort, Krishna Rajendra Rd, Kalasipalya, Bengaluru, Karnataka 560002
Bangalore
KARNATAKA |
9995657697
shameemt900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe,Bangalore medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
steristrips |
steristrips will be used for thyroidectomy wound closure and subcuticular sutures are not used in this scenario. |
| Comparator Agent |
Subcuticular sutures |
subcuticular sutures will be applied for the last step of thyroidectomy wound closure before applying dressing |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing total/hemi/subtotal thyroidectomy |
|
| ExclusionCriteria |
| Details |
Non compliant patients
Patients with secondary neck surgeries |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Post operative pain
Post operative neck mobility |
Post op day 1,2,3,30,90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative cosmesis |
Post op day 1,2,3,30,90 |
|
|
Target Sample Size
|
Total Sample Size="118"
Sample Size from India="118"
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)
|
04/04/2024 |
| 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)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study I am comparing the outcome of thyroidectomy wound closure using subcuticular sutures and steristrips in terms of post operative pain, neck mobility and post operative cosmesis on day 1,2,3,30 and 90, |