| CTRI Number |
CTRI/2025/04/085081 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON OF N-BUTYL 2 CYANOACRYLATE TISSUE ADHESIVE AND NYLON SUTURES IN EXTRAORAL MAXILLOFACIAL LACERATIONS AND INCISIONS – A RANDOMISED CONTROLLED TRIAL |
|
Scientific Title of Study
|
COMPARISON OF N-BUTYL 2 CYANOACRYLATE TISSUE ADHESIVE AND NYLON SUTURES IN EXTRAORAL MAXILLOFACIAL LACERATIONS AND INCISIONS – A RANDOMISED CONTROLLED SINGLE CENTERED TRIAL |
| Trial Acronym |
cyanoacrylate skin adhesives |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abdulla Noor M |
| Designation |
PG STUDENT |
| Affiliation |
KMCT dental college |
| Address |
Post graduate clinic, Dept of OMFS, KMCT dental college, manassery PO, Kozhikode, 673602
Dept of OMFS, KMCT dental college, manassery PO, Kozhikode
Kozhikode
KERALA
673602
India |
| Phone |
8547087111 |
| Fax |
|
| Email |
abdullanooromfs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abdulla Noor M |
| Designation |
PG STUDENT |
| Affiliation |
KMCT dental college |
| Address |
Post graduate resident, Dept of OMFS, KMCT dental college
manassery PO, Kozhikode
Kozhikode
KERALA
673602
India |
| Phone |
8547087111 |
| Fax |
|
| Email |
abdullanooromfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Abdulla Noor M |
| Designation |
PG STUDENT |
| Affiliation |
KMCT dental college |
| Address |
Post graduate clinic, Dept of OMFS, KMCT dental college
manassery PO, Kozhikode
Kozhikode
KERALA
673602
India |
| Phone |
08547087111 |
| Fax |
|
| Email |
abdullanooromfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abdulla Noor M,PG resident, Dept of OMFS, KMCT dental college |
|
|
Primary Sponsor
|
| Name |
Abdulla Noor M |
| Address |
PG resident, Dept of OMFS, KMCT dental college, Kozhikode, 673602 |
| 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 Abdulla Noor M |
KMCT hospital, |
Post graduate clinic, Dept of OMFS, KMCT dental college
manassery PO, Kozhikode
Kozhikode
KERALA |
08547087111
abdullanooromfs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCT DENTAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S008||Superficial injury of other partsof head, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cyanoacrylate tissue adhesives |
topical application of cyanoacrylate tissue adhesive on facial lacerations and incisions |
| Comparator Agent |
sutures |
lacerated or incised wounds closed using nylon sutures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age group is selected between 15 and 70 years
Lacerations should be within 5 cm length
Both sexes are included in the study
Patients who turn up for post operative evaluation
Clean, non contaminated lacerated wounds
Wounds of depth not more than 2 cm
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients
Lacerations which require to be closed under tension
Decubitus ulcer, crushed wounds and severe abrasions
Known person with family history of keloid or hypertrophied scar formation
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cyanoacrylate tissue adhesive reduces operative time |
immediate post operatively,3rd day, 7th day, 1 week, 2 weeks and i month post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| good hemostatic property |
immediate post operatively,3rd day, 7th day, 1 week, 2 weeks & 1 month post operatively |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="22"
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 1 |
|
Date of First Enrollment (India)
|
30/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="2"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The study is done to compare the efficacy of cyanoacrylate skin glue with nylon sutures on facial lacerations and incisions and note its inflammatory and aesthetic outcomes post operatively. |