| CTRI Number |
CTRI/2026/01/101558 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Skin Glue is Better Than Sutures for Closure of Laparoscopic PortSite Wound A Randomized Study |
|
Scientific Title of Study
|
A Comparative Study OF Cyanoacrylate Glue Application vs Conventional Suturing for Skin Closure of Laparoscopic Port Site A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushant Tiwatane |
| Designation |
Junior Resident |
| Affiliation |
S Nijalingappa Medical College and HSK Hospital Bagalkot |
| Address |
Department of General Surgery S Nijalingappa Medical College Navanagar Bagalkot
Bagalkot
KARNATAKA
587103
India |
| Phone |
7755940070 |
| Fax |
|
| Email |
sushanttiwatane1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Benakatti |
| Designation |
Professor |
| Affiliation |
S Nijalingappa Medical College and HSK hospital Bagalkot |
| Address |
Department of General Surgery S Nijalingappa Medical College Bagalkot
Bagalkot
KARNATAKA
587103
India |
| Phone |
9980716179 |
| Fax |
|
| Email |
Dr.rajendra.benakatti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sushant Tiwatane |
| Designation |
Junior Resident |
| Affiliation |
S Nijalingappa Medical College and HSK Hospital Bagalkot |
| Address |
Department of General Surgery S Nijalingappa Medical College and HSK Hospital Navanagar Bagalkot
Bagalkot
KARNATAKA
587103
India |
| Phone |
7755940070 |
| Fax |
|
| Email |
sushanttiwatane1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sushant Tiwatane |
| Address |
Department of General Surgery S Nijalingappa Medical College and HSK Hospital and Research Centre navanagar Bagalkot 587102 karnataka state India |
| 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 Sushant Tiwatane |
S Nijalingappa Medical College and HSK Hospital Bagalkot |
department of General surgery Nijalingappa Medical College and HSK Hospital navanagar Bagalkot
Bagalkot
KARNATAKA |
7755940070
sushanttiwatane1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SNMC, BAGALKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (4) ICD-10 Condition: K40-K46||Hernia, (5) ICD-10 Condition: O||Medical and Surgical, (6) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional sutures |
Sutures used to close port site skin in Laparoscopic surgeries for 18 months |
| Intervention |
N-BUTYL-2-CYANOACRYLATE GLUE |
Glue is used to close port site skin in Laparoscopic surgeries for 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 yrs to 65 yrs of patients undergoing laparoscopic surgery |
|
| ExclusionCriteria |
| Details |
Conversion of laparoscopic surgery to open surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Port site infection
Port site pain |
Patients will be assesed on POD 0 3 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="6"
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
|
The most common technique for wound closure continues to be sutures which have been used for generations. Other new techniques such as the use of adhesive Glue have been developed over time To know which method will produce the best results it is helpful to research and contrast new techniques such as cyanoacrylate glue The best technique for closing an incision must be simple riskfree fast quick inexpensive painless and bactericidal It should also result in less postoperative pain less wound infection and a shorter stay in the hospital Cyanoacrylate glue can be used as tissue adhesive as they are easy to apply and takes less time to close, offering hurdle to microorganisms at the healing location so it has less rate of wound infections, and the best cosmesis is achieved as compared to sutures Cyanoacrylate glue can be beneficial as there is less post-operative Pain and less chances of Surgical site Infection |