| CTRI Number |
CTRI/2025/09/094541 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
10/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
RANDOMIZED CONTROL TRIAL TO COMPARE WOUND DEHISCENCE RATES BETWEEN USE OF CYANOACRYLATE TISSUE GLUES ALONG WITH SUBCUTICULAR SKIN CLOSURE AND WITHOUT TISSUE GLUE IN SUBCUTICULAR SKIN CLOSURE. |
|
Scientific Title of Study
|
Single Blinded Randomized Control Trial To Compare Wound Dehiscence Rates And Surgical Outcomes With And Without Cyanoacrylate Tissue Glues In Oncoplastic Breast Surgery Patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANISHA KAPOOR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH (PGIMER ) |
| Address |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8219483502 |
| Fax |
|
| Email |
nishukpr07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ISHITA LAROIYA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ASSOCIATE PROFESSOR |
| Address |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8847496867 |
| Fax |
|
| Email |
Ishita_laroiya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ISHITA LAROIYA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Postgraduate institute research chandigarh |
| Address |
Postgraduate institute and research chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8847496867 |
| Fax |
|
| Email |
Ishita_laroiya@yahoo.com |
|
|
Source of Monetary or Material Support
|
| POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH, CHANDIGARH 160012 INDIA |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [India] |
|
|
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 |
| MANISHA KAPOOR |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
GENERAL SURGERY DEPARTMENT/
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
Chandigarh
CHANDIGARH |
8219483502
nishukpr07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE (INTRAMURAL PGIMER CHANDIGARH) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SUBCUTICULAR MONOCRYL SUTURE WITH CYANOACRYLATE TISSUE GLUE |
SUBCUTICULAR SKIN CLOSURE DONE WITH MONOCRYL SUTURE AFTER WHICH CYANOACRYLATE IS APPLIED ON WOUND EDGES, COVERING 5-10MM ON EITHER SIDE OF WOUND EDGES. |
| Comparator Agent |
SUBCUTICULAR MONOCRYL SUTURE |
ONLY SUBCUTICULAR SKIN CLOSURE DONE WITH MONOCRYL SUTURE . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
All Patients undergoing OPBS |
|
| ExclusionCriteria |
| Details |
Known allergies to tissue glues
- History of keloid formation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOUND DEHISCENCE RATES BETWEEN TWO GROUPS |
4 WEEKS AND 12 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
DIFFERENCE IN WOUND INFECTION RATES BETWEEN TWO GROUPS
2)WOUND INFECTION
3)TIME TO START ADJUVANT TREATMENT
4) COSMETIC ANALYSIS
4)OVERALL COMPLICATIONS RATES. |
4 WEEKS AND 12 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
25/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
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
|
ALL PATIENTS UNDERGOING BREAST CONSERVATION SURGERY ARE RANDOMIZED INTO TWO GROUPS USING COMPUTER-BASED RANDOMIZATION. IN GROUP A, SUBCUTICULAR MONOCRYL SKIN CLOSURE ALONG WITH TISSUE GLUE IS APPLIED TO THE WOUND EDGES, AND IN GROUP B, SUBCUTICULAR MONOCRYL SUTURE SKIN CLOSURE DONE. PATIENTS ARE FOLLOWED UP FOR WOUND DEHISCENCE RATES AT 4 WEEKS AND 12 WEEKS. |