| CTRI Number |
CTRI/2012/11/003124 [Registered on: 19/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
16/11/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial comparing the use of skin glue versus stitches in the closure of skin incisions in laparoscopic surgery |
|
Scientific Title of Study
|
A randomized controlled parallel group study on 2-octyl cyanoacrylate versus non-absorbable simple interrupted sutures in the closure of skin incisions at laparoscopic port sites |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CARE id: EC/OA-47/2010, version 2 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Deshpande |
| Designation |
Professor and unit head |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of surgery,
Seth G.S. Medical College and K.E.M. Hospital
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400012
India |
| Phone |
|
| Fax |
|
| Email |
draparnadeshpande@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Ninad Maniar |
| Designation |
Medical student |
| Affiliation |
Seth G.S. Medical College and K.E.M. Hospital |
| Address |
E-201 Laxmi Ratan Soc.
9-Ratan Nagar
Four Bunglows
Andheri-west
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
9819867033 |
| Fax |
|
| Email |
ninadm2006@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Ninad Maniar |
| Designation |
Medical student |
| Affiliation |
Seth G.S. Medical College and K.E.M. Hospital |
| Address |
E-201 Laxmi Ratan Soc.
9-Ratan Nagar
Four Bunglows
Andheri-west
Mumbai
Mumbai (Suburban)
MAHARASHTRA
400053
India |
| Phone |
9819867033 |
| Fax |
|
| Email |
ninadm2006@gmail.com |
|
|
Source of Monetary or Material Support
|
| Seth GS Medical College and KEM Hospital |
|
|
Primary Sponsor
|
| Name |
Seth GS Medical College and KEM Hospital |
| Address |
Parel
Mumbai |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Seth GS Medical College and KEM Hospital |
Parel
Mumbai |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mr Ninad Maniar |
Seth GS Medical College and KEM Hospital |
Acharya Donde Marg
Parel
Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9819867033
ninadm2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee for Academic Research Ethics, Seth GS Medical College and KEM Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Undergoing elective laparoscopic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2-octyl cyanoacrylate tissue adhesive |
One unit(tube) of this adhesive was administered once topically at the incision site at the time of skin closure. |
| Comparator Agent |
Non-absorbable polyamide simple interrupted sutres |
One unit(packet) of the suture was used to close the skin incision. The technique used was simple interrupted suturing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
undergoing elective laparoscopic surgery
|
|
| ExclusionCriteria |
| Details |
Refusal to consent
Refusal to follow up |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy (approximation achieved) of both methods |
post-op day 1 and 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Operative time for closure
|
Intra-operative |
| Pain |
Post-op day 1 |
| infection |
post-op day 1 and 7 |
| Cost |
Pre-calculated; one unit each |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/09/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Still to apply. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction:
The
large array of new techniques for closure of surgical incisions can make the
proper choice for closure a challenge. Data on the use of 2-octyl cyanoacrylate
(adhesives) in skin closure of laparoscopic incisions is limited. Available
data is generated from developed countries where cost considerations are
different from those in our setting.
Aim:
This
study aims to investigate the benefits and shortcomings of 2-octyl
cyanoacrylate versus non-absorbable simple interrupted sutures in terms of
efficacy, intra-operative time, post-operative pain, infection and cost.
|