| CTRI Number |
CTRI/2024/03/064182 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Choice of closure of skin for midline abdominal surgeries |
|
Scientific Title of Study
|
Conventional sutures vs staplers for closure of skin in midline laparotomy wounds |
| 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 Shetty Ashish Naveena |
| Designation |
Junior resident |
| Affiliation |
Kasturba hospital, Manipal |
| Address |
Department of general surgery, Kasturba medical college, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9821697085 |
| Fax |
|
| Email |
ashish.kmcmpl2023@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annappa Kudva |
| Designation |
Professor and head of unit |
| Affiliation |
Kasturba hospital, Manipal |
| Address |
Department of general surgery, Kasturba medical college, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448857394 |
| Fax |
|
| Email |
annappa.kudva@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jithin Abraham Jacob |
| Designation |
Assistant professor |
| Affiliation |
Kasturba hospital, Manipal |
| Address |
Department of general surgery, Kasturba medical college, MAHE, Manipal
KARNATAKA
576104
India |
| Phone |
9632883146 |
| Fax |
|
| Email |
jithin.abraham@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of general surgery, kasturba hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [NA] |
|
|
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 Shetty Ashish Naveena |
Kasturba Hospital, Manipal |
Department of general surgery, 3rd floor new opd block, Kasturba hospital, Manipal 576104
Udupi
KARNATAKA |
9821697085
ashish.kmcmpl2023@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and Kasturba hospital institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient undergoing midline laparotomy in Department of General Surgery, Kasturba hospital Manipal
2)Patient older than 18 years of age
3)Patient consenting to be a part of the study |
|
| ExclusionCriteria |
| Details |
1)Patient not willing to participate in the study 2)patient failing to follow up
3)Patient less than 18 years of age
4)Previous h/o laparotomy
5)Previous h/o keloid/hypertrophic scar |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare surgical site infection and postoperative pain in sutures vs staplers for closure of skin in midline laparotomy wounds |
postoperative day 1,3,7- for postoperative pain and surgical site infection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken for closure of skin and final cosmetic appearance of scar in sutures vs staplers for closure of skin in midline laparotomy wounds |
Intraoperative - for time taken for closure of skin
Postoperative day 30- for final cosmetic appearance |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
27/03/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patient will be approached for participating in the study and will be explained the details of this study. Once the patient agrees, informed consent will be taken. The case will then be recruited into the study in either Sutures or Staplers group depending on intra-operative decisions made by the treating surgeon. There will be no pre study randomization. We will assess the factors like time taken for closure of skin, post-operative pain on immediate post-operative days(POD) as follows- POD1, POD3 and POD 7. We will also assess postoperative complications like surgical site infection, days of hospital stay after surgery and patients will be followed up at the end of 1 month on OPD basis to assess final cosmetic appearance of scar. |