| CTRI Number |
CTRI/2025/04/084221 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| 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
|
COMPARING TWO TYPES OF STITCHING TECHNIQUES (CONTINUOUS VS INTERRUPTED) TO PREVENT WOUND COMPLICATIONS AFTER EMERGENCY ABDOMINAL SURGERY. |
|
Scientific Title of Study
|
COMPARISON OF INCIDENCE OF WOUND COMPLICATIONS IN CONTINUOUS VERSUS INTERRUPTED SUTURING OF ABDOMINAL FASCIAL CLOSURE IN EMERGENCY MIDLINE LAPAROTOMY A RANDOMIZED CONTROLLED TRIAL |
| Trial Acronym |
COVINAC TRIAL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Naga Sricharan Maharshi Pulluri |
| Designation |
Junior Resident |
| Affiliation |
All India Insitute Of Medical Sciences Raipur |
| Address |
4th floor, D block, Department of General Surgery
AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8341851724 |
| Fax |
|
| Email |
charan.pulluri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmendra Dugar |
| Designation |
Additional Professor |
| Affiliation |
All India Insitute Of Medical Sciences Raipur |
| Address |
4th floor, D block, Department of General Surgery, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9437091846 |
| Fax |
|
| Email |
dddugar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhamendra Dugar |
| Designation |
Additional Professor |
| Affiliation |
All India Insitute Of Medical Sciences Raipur |
| Address |
4th floor, D block, Department of General Surgery, AIIMS Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9437091846 |
| Fax |
|
| Email |
dddugar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of General Surgery, All India Institute of Medical Sciences, Tatibandh, Raipur, India- 492099 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAIPUR. |
| Address |
TATIBANDH, RAIPUR, CHHATTISGARH, INDIA.
PINCODE:492099 |
| Type of Sponsor |
Government medical college |
|
|
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 Naga Sricharan Maharshi Pulluri |
All India Institute of Medical Sciences Raipur |
Trauma and Emergency OT, Department of General Surgery, 3rd floor, Trauma Building
Raipur
CHHATTISGARH |
8341851724
CHARAN.PULLURI@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS RAIPUR. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: L768||Other intraoperative and postprocedural complications of skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Continuous Suturing of Rectus Sheath |
Closure of Rectus sheath with Polypropylene 1-0 suture by continuous technique with 0.5 cm distance from margin and between two sutures from one end to other end of incision |
| Intervention |
Interrupted Rectus Sheath closure |
Closure of the Rectus Sheath incision using Polypropylene 1-0 suture by Interrupted technique with 0.5 cm distance from the margin and between the two sutures from one end to other end of the incision |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients more than 18 years undergoing emergency midline laparotomy |
|
| ExclusionCriteria |
| Details |
1 Patient undergoing elective surgeries
2 Patients with known connective tissue disorders
3 Re-exploration within 30 days through same incision
4 Laparostomy.
5 Death within 2 days of surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the incidence of wound complications with respect to SSI, Wound Dehiscence, and Burst Abdomen in Emergency Midline Laparotomy. |
During hospital stay, 30th Day and 90th Day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the incidence of wound complication in continuous, vs interrupted abdominal fascial closure. |
During hospital stay, 30th Day and 90th Day. |
| Duration of post operative hospitalization (Length of Stay). |
Duration of Hospital stay |
| Suturing time for Rectus Sheath closure, |
intraoperative period. |
Incidence of Chronic Pain on day 3rd , 30th, 90th day- Pain score(VAS).
|
day 3, 30 and 90 postoperatively. |
| Incisional Hernia at the time of 3 month Follow Up. |
90Days post operatively. |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
18/04/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
In this trial, I am going to compare the incidence of wound complications with respect to surgical site infection (SSI), wound dehiscence, and burst abdomen. I will also evaluate the duration of postoperative hospitalisation (length of stay), suturing time for rectus sheath closure, incidence of chronic pain on the 3rd, 30th, and 90th postoperative days using the pain score (VAS), and the occurrence of incisional hernia at the 3-month follow-up in patients undergoing emergency midline laparotomies at AIIMS Raipur. |