| CTRI Number |
CTRI/2021/03/031927 [Registered on: 11/03/2021] Trial Registered Prospectively |
| Last Modified On: |
10/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry
Other (Specify) [Tissue adhesive( n butyl cyanoacrylate )material for wound closure] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of clinical efficacy and esthetic outcomes between
n-butyl cyanoacrylate tissue adhesive and prolene suture material for wound closure in orbital floor and orbital rim fracture fixation
|
|
Scientific Title of Study
|
Tissue adhesive v/s suture wound closure methods for lower lid skin approaches used in ORIF of infraorbital fractures: a prospective blinded randomized control study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asha V Shet |
| Designation |
Post graduation In Oral And Maxillofacial SURGERY |
| Affiliation |
Craniofacial surgery and research centre SDM UNIVERSITY |
| Address |
Dept of oral and maxillofacial surgery
Dept no:3
SDM College of dental sciences and hospital
no:1
DHYAANA Building Rajaji Nagar Behind SDM College of dental sciences and hospital Sattur DHARWAD
Dept no:3
SDM College of dental sciences and hospital
Dharwad
KARNATAKA
580009
India |
| Phone |
8105518756 |
| Fax |
|
| Email |
ashashet96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Abhijit S Joshi |
| Designation |
Additional Professor in department of oral and maxillofacial surgery |
| Affiliation |
Sdm University CFU Sdm College of dental sciences and hospital |
| Address |
Craniofacial surgery and research centre
Department of oral and maxillofacial surgery
Room no:3
SDM College of dental sciences and hospital
Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
9972019197 |
| Fax |
|
| Email |
drabhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asha V Shet |
| Designation |
Post graduation IN Oral and Maxillofacial SURGERY |
| Affiliation |
Sdm University CFU Sdm College of dental sciences and hospital |
| Address |
SDM College of dental sciences and hospital
Department of Exodontia
Room no :3
Sattur Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
8105518756 |
| Fax |
|
| Email |
ashashet96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Craniofacial surgery and research centre SDM College of dental sciences and hospital Sattur Dharwad
|
|
|
Primary Sponsor
|
| Name |
Dr Asha V Shet |
| Address |
Craniofacial surgery and research centre SDM College of dental sciences and hospital Sattur Dharwad |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Asha V Shet |
Craniofacial surgery and research centre |
Department of oral and maxillofacial surgery room no:3
SDM College of dental sciences and hospital Sattur Dharwad
Dharwad
KARNATAKA |
8105518756
ashashet96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCDSH- INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Prolene (5-0 polypropylene) suture material |
The comparator agent would be the conventionally used 5-0 polypropylene suture material under brand name prolene is used for closure of lower blepharoplasty after fixation of orbital floor and or rim fracture which will be compared with the intervention tissue adhesive material |
| Intervention |
Tissue adhesive (n butyl cyanoacrylate-histocryl) |
Tissue adhesive material (n butyl cyanoacrylate under the brand name (histocryl) would be used as an intervention for wound closure after lower blepharoplasty post orbital floor and rim fracture fixation instead of conventional prolene suture material suture |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing subcilliary incisions for Open reduction and Internal Fixation of Orbital rim and/ or floor fracture.
|
|
| ExclusionCriteria |
| Details |
ii.a)Patients who refuse surgical exploration of the orbital fractures.
b)Patients who refuse to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
the esthetic outcomes,clinical and surgical efficacy and duration of closure of n-butyl cyanoacrylate over 5-0 prolene for lower blepharoplasty.
|
Outcomeswill be assessed at 2nd week post op,4 th week post op and 3 rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Better QUALITY OF CLOSURE
a. eversion
b. requirement of handle sutures
c. approximation-
D.duration
E.scarring |
At 2nd week 4th week and 3rd month postoperative |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/03/2021 |
| 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="11"
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)?
Response - NO
|
|
Brief Summary
|
A comparative study analysing the esthetic outcomes,clinical efficacy wound closure properties of n butyl cyanoacrylate-histocryl tissue adhesive material and 5-0 polypropylene subcuticular suturing suture material for the lower blepharoplasty after fixation of orbital floor and or rim fractures. A double blinded randomised controlled trial Patients will be randomly allocated into suture (5-0 polypropylene)gruop and tissue adhesive (n butyl cyanoacrylate-histocryl ) gruop Intraop parameters like duration of closure wound approximation eversion and post op healing scarring esthetics will be assessed on periodic follow ups by blinded observers. |