| CTRI Number |
CTRI/2019/11/022020 [Registered on: 15/11/2019] Trial Registered Prospectively |
| Last Modified On: |
20/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the appearance of scar after using either tissue glue or stitches for closing facial surgery wound |
|
Scientific Title of Study
|
Comparative Evaluation of the Esthetic Outcomes of Octyl 2 Cyanoacrylate Skin Adhesive and Ethilon Suture in Patients requiring Skin Incisions in Maxillofacial Surgery: A Randomized Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 04/2017 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ruchita Balkawade |
| Designation |
Post-graduate student |
| Affiliation |
MGM Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Room no.3, second floor,
MGM Dental College and Hospital,
Junction of NH4 and Sion-Panvel Expressway, Sector-18,
Navi Mumbai, Maharashtra-410209
Raigarh
MAHARASHTRA
400706
India |
| Phone |
9082265483 |
| Fax |
|
| Email |
ruchitabalkawade11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Asnani |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Room no.3, second floor,
MGM Dental College and Hospital,
Junction of NH4 and Sion-Panvel Expressway, Sector-18,
Navi Mumbai, Maharashtra-410209
Raigarh
MAHARASHTRA
400614
India |
| Phone |
9820897181 |
| Fax |
|
| Email |
drushaasnani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srivalli Natarajan |
| Designation |
Professor |
| Affiliation |
MGM Dental College and Hospital |
| Address |
Department of Oral and Maxillofacial Surgery, Room no.3, second floor,
MGM Dental College and Hospital,
Junction of NH4 and Sion-Panvel Expressway, Sector-18,
Navi Mumbai, Maharashtra-410209
Raigarh
MAHARASHTRA
400078
India |
| Phone |
9769088803 |
| Fax |
|
| Email |
srivallis@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Oral and Maxillofacial Surgery, Room no. 3, Second floor, MGM Dental College and Hospital, Kamothe, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Department of Oral Maxillofacial Surgery |
| Address |
MGM Dental College and Hospital
Address: MGM Dental College and Hospital,
Junction of NH4 and Sion-Panvel Expressway, Sector-18,
Navi Mumbai, Maharashtra-410209
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ruchita Balkawade |
MGM Dental College and Hospital |
Department of Oral and Maxillofacial Surgery, Room no. 3, Second floor,
MGM Dental College and Hospital, Kamothe, Navi Mumbai
Raigarh
MAHARASHTRA |
9082265483
ruchitabalkawade11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MGM Dental College and Hospital, Kamothe, Navi Mumbai |
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 |
| Comparator Agent |
Ethilon Sutures |
Skin closure using 4-0 Ethilon sutures that will be removed after 7 days |
| Intervention |
Octyl 2 Cyanoacrylate |
Skin closure using dermabond which flakes off in 7 - 10 days |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between age group 15-50 years.
2. Patients both males and females will be included.
3. Clean elective extra-oral surgical incisions.
4. Patients who would require retromandibular or submandibular surgical incisions.
5. Extra-oral surgical incision length 2-8cm.
6. Incision with good approximation of edges where closure would not be under tension.
7. Patient willingness for study and follow up.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic conditions impairing wound healing (uncontrolled diabetes mellitus, vascular problems, coagulation disorders, peripheral vascular disorders).
2. Patients on immunomodulators (steroids, cyclosporine).
3. Patients with known tendency of hypertrophic scar or keloid formation.
4. Extra-oral surgical wounds in the region of malignancy.
5. Extra-oral surgical wounds in the region of mucocutaneous junction, periocular region.
6. Extra-oral surgical wounds in the region where there is visual evidence of active infection, rash or skin lesions.
7. Extra-oral surgical wounds in the region covered by natural hair.
8. Patients with known history of hypersensitivity to formaldehyde or cyanoacrylates.
9. Uncooperative patients and mentally retarded patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the esthetic results achieved using octyl-2-cyanoacrylate skin adhesive and ethilon suture in patients requiring skin incisions in maxillofacial surgery |
End of 1st and 3rd post-operative month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observe tissue response and incidence of complications involved with the use of octyl-2-cyanoacrylate skin adhesive and ethilon suture in patients requiring skin incisions in maxillofacial surgery |
7th, 15th day and 1st month post-operatively |
| Compare the time taken for skin closure achieved using octyl-2-cyanoacrylate skin adhesive and ethilon suture in patients requiring skin incisions in maxillofacial surgery |
at the time of closure |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/11/2019 |
| Date of Study Completion (India) |
02/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, randomized, single blinded, unicentre study to compare the esthetic outcomes of octyl-2-cyanoacrylate and ethilon sutures carried out in a total of 20 patients. The primary outcome evaluates and compares the esthetic resuts of octyl-2-cyanoacrylate and ethilon sutures using Manchester Scar Scale at the end of 1st month and 3rd month post-operatively while secondary outcome observes the tissue response and incidence of complications using Wound Evaluation Scale & ASEPSIS Score at Day 7, Day 15 and end of 1st month post-operatively as well as compares the time taken in skin closure. |