| CTRI Number |
CTRI/2024/07/069878 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
To see if local application of tranexamic acid reduces seroma formation in patients undergoing ventral hernia surgery |
|
Scientific Title of Study
|
To compare the incidence of seroma formation with or without local application of tranexamic acid in ventral herioplasty -a randomized control 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 |
Janani Devi Colon |
| Designation |
PG Resident |
| Affiliation |
Sri manakula vinayagar medical college and hospital, puducherry |
| Address |
Department of general surgery, Sri Manakula Vinayagar medical college and hospital,
Pondicherry 605107
Department of general surgery, Sri Manakula Vinayagar medical college and hospital,
Pondicherry 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894585170 |
| Fax |
|
| Email |
jananicolon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
G V Manoharsn |
| Designation |
Professor and head of department |
| Affiliation |
Sri manakula vinayagar medical college and hospital |
| Address |
Department of general surgery surgery Sri manakula vinayagar medical college and hospital
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9894585170 |
| Fax |
|
| Email |
gvmanoharan14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Janani Devi Colon |
| Designation |
PG Resident |
| Affiliation |
Sri manakula vinayagar medical college and hospital, puducherry |
| Address |
Department of general surgery, Sri manakula vinayagar medical college and hospital,
Pondicherry 605107
Department of general surgery, Sri manakula vinayagar medical college and hospital,
Pondicherry 605107
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894585170 |
| Fax |
|
| Email |
jananicolon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Janani Devi Colon, Department of general surgery, Sri manakula vinayagar medical college and hospital , Puducherry- 605107
India |
|
|
Primary Sponsor
|
| Name |
Janani Devi Colon |
| Address |
No 46 SBI colony , mohan nagar extension , puducherry 605006
|
| Type of Sponsor |
Other [Self funding ] |
|
|
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 |
| DrJanani Devi Colon |
Sri Manakula Vinayagar Medical college and Hospital |
Department of general surgery, Sri Manakula Vinayagar Medical college and Hospital,Pondicherry
Pondicherry
PONDICHERRY |
9894585170
jananicolon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
Normal saline is applied under surface of skin flap and skin is closed, daily drain output is measured from postoperative day1 to day 5 |
| Intervention |
To reduce seroma formation in ventral hernioplasty using tranexamic acid |
Tranexamic acid is applied under the skin flap and skin is closed, daily drain output is measured from day 1 to day 5 postoperatively |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient having ventral hernia aged between 18 years to 80 years are included in the study. Both male and female genders are included.
Hernial Defect size more than 2cms.
patient who are able to understand the merits and demerits.
|
|
| ExclusionCriteria |
| Details |
Patient having ventral hernia aged less than 16 years and above 80 years are excluded from the study.
Cirrhosis
Uncontrolled Diabetes Mellitus, chronic kidney disease
not willing to participate in the trial
BMI more than 35
recurrence, Strangulated hernia, pregnancy
patient with severe anaemia |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Seroma formation is measured in test group (using tranexamic acid) than the control group ( using normal saline) |
daily drain output till day 5 of postoperative period is estimated and compared with control group |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction of seroma formation using application of tranexamic acid compared with normal saline |
first 5 days of post operative period |
|
|
Target Sample Size
|
Total Sample Size="98"
Sample Size from India="98"
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 2 |
|
Date of First Enrollment (India)
|
14/07/2024 |
| 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="8"
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 main objective of this study is to find out reduction in seroma formation with local application of tranexamic acid before skin closure in ventral hernioplasty . Two groups A and B were randomized and one group receives local application of tranexamic acid before skin closure and in other group skin is closed without application of tranexamic acid. the drain output volume ion the following postoperative days were monitored and the output of fifth postoperative day is compared between two groups . The outcome of seroma reduction using tranexamic acid will be evaluated and if there is significant decrease in seroma formation using tranexamic acid it mat be used in large ventral hernia to prevent seroma and further complication such as infection, wound gapping following seroma formation |