| CTRI Number |
CTRI/2025/09/095025 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Is cyanoacylate glue better than subcuticular suturing in facial surgeries? An exploratory randomized study |
|
Scientific Title of Study
|
SUTURE-FREE VERSUS TRADITIONAL CLOSURE:
A COMPARATIVE STUDY OF 2- OCTYL CYANOACRYLATE ADHESIVES AND SUBCUTICULAR SUTURING IN FACIAL SURGERIES- AN EXPLORATORY RANDOMIZED CLINICAL STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nazish Khan |
| Designation |
Junior Resident Academic |
| Affiliation |
AIIMS rishikesh |
| Address |
Department of Dentistry, AIIMS Rishikesh, Rishikesh, Uttarakhand
Department of Dentistry, AIIMS Rishikesh, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
07982080809 |
| Fax |
|
| Email |
khannazish156@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashi Chug |
| Designation |
Professor and Head of Department |
| Affiliation |
AIIMS Rishikesh |
| Address |
Department of Dentistry, AIIMS Rishikesh, Rishikesh, Uttarakhand
Department of Dentistry, AIIMS Rishikesh, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8475000290 |
| Fax |
|
| Email |
ahichug@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nazish Khan |
| Designation |
Junior Resident Academic |
| Affiliation |
AIIMS rishikesh |
| Address |
Department of Dentistry, AIIMS rishikesh, Rishikesh, Uttarakhand
Department of Dentistry, AIIMS rishikesh, Rishikesh, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
07982080809 |
| Fax |
|
| Email |
khannazish156@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Nazish Khan |
| Address |
Department of Dentistry, AIIMS Rishikesh, Uttarakhand, India
Pin code 249203 |
| 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 Nazish Khan |
AIIMS Rishikesh |
Department of Oral and Maxillofacial surgery, Dentistry, AIIMS Rishikesh
shivaji nagar
Rishikesh, Uttarakhand 249203
Dehradun
UTTARANCHAL |
07982080809
khannazish156@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M279||Disease of jaws, unspecified, (2) ICD-10 Condition: V99||Unspecified transport accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2-Octylcyanoacrylate |
2-Octylcyanoacrylate for closure of the last layer in extroral incisions in case of of facial surgeries. 2-Octyl cyanoacrylate (OCA) adhesives like Dermabond is a skin adhesive which polymerizes upon contact with blood, creating skin stabilization within 10 seconds. Cyanoacrylate forms bridge, binding the two wound edges together and allowing normal healing below. |
| Comparator Agent |
Subcuticular suturing |
Subcuticular suturing technique will be used using prolene suture as the last layer of closure for extraoral incisions in facial surgeries. Subcuticular suture constitutes an intradermal approach, with sutures situated beneath the epidermis. Prolene is a brand of synthetic polypropylene used in monofilament nonabsorbable sutures. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I patients
Systemically healthy patients with age ranging between 5- 75 yearsSubject requiring extraoral approach for maxillofacial surgeries |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions and impaired wound healing (uncontrolled
diabetes mellitus, vascular problems, coagulation disorders and peripheral
vascular disorders)
Patients on immunomodulators (steroids and cyclosporine), with known
tendency of hypertrophic scar or keloid formation.
Patients with special needs or with any mental problems
Subject with active skin infection and known history of hypersensitivity to
formaldehyde or cyanoacrylates |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Scar Assessment |
Scar assessment will be done using Modified Hollander Scale on the 9th, 15th days, 1 month and 3 month follow ups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Time taken
Complications
Patient satisfaction
Allergic Contact Dermatitis (ACD) |
Scar assessment will be done using Modified Hollander Scale on the 9th, 15th days, 1 month & 3 month follow ups |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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)
|
Not Applicable |
| 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
|
This study aims to compare the effectiveness of the 2- octyl cyanoacrylate skin adhesive in comparison to the traditional subcuticular suturing technique in case of facial incisions. |