| CTRI Number |
CTRI/2020/07/026584 [Registered on: 15/07/2020] Trial Registered Prospectively |
| Last Modified On: |
09/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of cosmetic appearence between various methods of thyroidectomy wound closure |
|
Scientific Title of Study
|
Comparison of aesthetic outcome between sterile tissue adhesive strips and subcuticular sutures in post thyroidectomy patients - a randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohneesh Pandey |
| Designation |
Resident general surgery |
| Affiliation |
Afmc |
| Address |
Dept of general surgery Armed forces medical college wanowarie pune
Pune
MAHARASHTRA
411040
India |
| Phone |
08257099460 |
| Fax |
|
| Email |
mohneeshpandey22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nilanjan roy |
| Designation |
Associate professor,dept of general surgery |
| Affiliation |
Armed forces medical college pune |
| Address |
Dept of general surgery Armed forces medical college wanowarie pune
Pune
MAHARASHTRA
411040
India |
| Phone |
9923364881 |
| Fax |
|
| Email |
nilanjanroyd604@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohneesh Pandey |
| Designation |
Resident general surgery |
| Affiliation |
Afmc |
| Address |
Dept of general surgery Armed forces medical college wanowarie pune
Pune
MAHARASHTRA
411040
India |
| Phone |
08257099460 |
| Fax |
|
| Email |
mohneeshpandey22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Armed Forces Medical College,Pune |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College Pune |
| Address |
Dept of general surgery Armed forces medical college wanowarie pune |
| 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 |
| Mohneesh pandey |
Armed forces medical college and Command Hospital (SC) Wanowarie Pune |
Department Of Surgery Armed Forces Medical College Wanowarie Pune PIN 411040
Pune
Maharashtra
Pune
MAHARASHTRA |
08257099460
mohneeshpandey22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E079||Disorder of thyroid, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Sterile tissue adhesive strips |
Tissue adhesive strips are a method of skin closure especially in lacerated wound on face and fingers.It does not cause laceration and is technically easy to apply on skin surface |
| Comparator Agent |
Subcuticular sutures in thyroidectomy wound closure |
It is a suturing technique wherein the suture is passed through the wound,exiting the skin distal to the apex and the ends are cut flush with the skin |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All the patients aged 18 and above who will undergo thyroidectomy at this center |
|
| ExclusionCriteria |
| Details |
Patient having previous neck incision over the site of intended incision or post radiotherapy patients.
Cervical lymphadenopathy needing radical neck dissection
Prescence of dermatological conditions over the neck.
Unable to provide informed written consent |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare aesthetic outcome of post thyroidectomy scar between closure by subcuticular sutures and sterile adhesive strips by implementing POSAS score |
Baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
20/07/2020 |
| 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
|
Thyroid surgery is the most commonly performed surgery by general surgeons in neck via a collar neck incision.For the last decade, remote access thyroidectomy and natural orifice transluminal endoscopic surgery ( NOTES) have been popularised as they leave no visible scar on the neck and therefore are deemed to yield superior cosmetic result, however conventional thyroidectomy is still the mainstay of treatment.Among two of the popular methods for thyroidectomy skin closure are subcuticular sutures and adhesive strips.Placement of subcuticular sutures requires more technical expertise than with tissue adhesive strips.As the optimal method of wound closure still remains ambiguous the current study is planned to compare the efficacy of different methods of thyroid surgery wound closures |