| CTRI Number |
CTRI/2024/06/069381 [Registered on: 24/06/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A surgical trial to study the comparison of two different stitch technique (long and short) for the healing of wound following the surgery to open the belly area(abdomen). |
|
Scientific Title of Study
|
Comparison of wound outcome in short and long stitch
sheath closure following emergency exploratory
laparotomy |
| 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 Akshita |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College & Safdarjung Hospital |
| Address |
Department of General Surgery
VMMC & Safdarjung Hospital,
New Delhi
South West
DELHI
110029
India |
| Phone |
9582673437 |
| Fax |
|
| Email |
akshita.akshita.54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Indu Bhushan Dubey |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College & Safdarjung Hospital |
| Address |
Department of General Surgery
VMMC & Safdarjung Hospital,
New Delhi
South West
DELHI
110029
India |
| Phone |
9868831328 |
| Fax |
|
| Email |
dribdubey@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Indu Bhushan Dubey |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College & Safdarjung Hospital |
| Address |
Department of General Surgery
VMMC & Safdarjung Hospital,
New Delhi
South West
DELHI
110029
India |
| Phone |
9868831328 |
| Fax |
|
| Email |
dribdubey@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, VMMC And SAFDARJUNG HOSPITAL, Ring Road Ansari Nagar, New Delhi, Delhi- 110029, India |
|
|
Primary Sponsor
|
| Name |
No Sponsor |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Akshita |
SAFDARJUNG HOSPITAL, DELHI |
New Emergency Building OT 2nd Floor, Department of General Surgery, VMMC And SAFDARJUNG HOSPITAL Ring Road Ansari Nagar New Delhi
South West
DELHI |
9582673437
akshita.akshita.54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee VMMC and SJH VMMC And SAFDARJUNG HOSPITAL Ring Road Ansari Nagar New Delhi South Delhi Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Long Stitch Technique |
Sheath closure will be done in continuous fashion by placing the
sutures 1 cm from rectus edge with inter-suture distance of 1 cm from using 0’PDS suture
single 150 cm thread with HR 40 mm needle.
|
| Intervention |
Short Stitch Technique |
Sheath closure will be performed in continuous fashion by placing
the sutures 5 mm from rectus edge with an inter-suture distance of 5 mm from the wound
edge performed using 0’PDS suture single 150 cm thread with HR 40 mm needle. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA:
1 Patients more than 12 years of age. |
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1 Pregnancy
2 Previous surgical procedures of the abdomen
3 Pathology not suitable for primary closure of rectus sheath
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Wound outcome in both long and short stitch sheath closure according to WUWHS SWD grading system - I,Ia,II,IIa,III,IIIa,IV,IVa for incidence of wound dehiscence, surgical site
infection as per Southampton wound grading system - 0,I,II,III,IV,V and pain according to visual
analogue scale.
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Wound outcome in both long and short stitch sheath closure according pain according to visual
analogue scale.
|
30 days |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/06/2024 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/07/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is an Observational Analytical, Randomized, Parallel Group Trial comparing the wound outcome in short stitch and long stitch sheath closure following laparotomy. The study would be conducted in a single centre in India - Department of General Surgery, VMMC & Safdarjung Hospital, New Delhi. 94 patients would be studied. The study period being 18 months.The Objectives are the Comparison of the wound outcome in short and long stitch sheath closure following laparotomy in terms of Incidence of Surgical site infection using Southampton grading system; Incidence of wound dehiscence according to WUWHS (World Union of Wound Healing Societies) Sandy grading system; Time taken to close sheath with respect to size of incision and the Pain according to visual analogue scale.
Study Hypothesis - The wound outcome in short and long stitch sheath closure following laparotomy is comparable. |