| CTRI Number |
CTRI/2025/07/090520 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| 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
|
Randomised clinical trial to evaluate incision related complication of abdominal wall closure in case of intestinal perforation by barbed vs non-barbed suture in north indian population . |
|
Scientific Title of Study
|
Evaluation of incision related complication in emergent abdominal fascial closure with
barbed vs non-barbed suture type in hollow viscous perforation: randomized clinical trial
in north Indian population
|
| 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. Amit Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Room no.628, Hospital Block Department of General surgery AIIMS Raebareli
Rae Bareli UTTAR PRADESH 229405 India |
| Phone |
8433028881 |
| Fax |
|
| Email |
amitonline44@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Amit Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Room no. 628, Hospital Block Department of General surgery AIIMS Raebareli
Rae Bareli UTTAR PRADESH 229405 India |
| Phone |
8433028881 |
| Fax |
|
| Email |
amitonline44@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Amit Kumar Gupta |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Room no.628, Hospital Block Department of General surgery AIIMS Raebareli
Rae Bareli UTTAR PRADESH 229405 India |
| Phone |
8433028881 |
| Fax |
|
| Email |
amitonline44@gmail.com |
|
|
Source of Monetary or Material Support
|
| MRU Division, AIIMS Raebareli, Uttar Pradesh , pincode:229405, India |
|
|
Primary Sponsor
|
| Name |
MRU Division AIIMS Raebareli |
| Address |
AIIMS Raebareli, Uttar Pradesh ,Pincode-229405, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Amit Kumar Gupta |
AIIMS Raebareli |
Department of General Surgery, Sixth Floor, Hospital Block Rae Bareli UTTAR PRADESH |
08433028881
amitonline44@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BIOETHICS CELL ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RAEBARELI |
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 |
| Intervention |
Absorbable Barbed Suture |
Symmetrical Barbed PDS Suture |
| Comparator Agent |
Absorbable Suture |
PDS Loop Suture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients undergoing emergency laparotomy for hollow viscous perforation with primary fascial closure |
|
| ExclusionCriteria |
| Details |
1.Age less than 18 years
2.Immunocompromised patient
3.Unstable patient undergoing damage control surgery
4.Patient having midline scar /incisional hernia
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Rate of abdominal wall dehiscence/or burst abdomen in the patients undergoing emergent abdominal fascial closure in hollow viscous perforation.
|
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| superficial SSI in 30 days fallow up period length of hospital stay |
6 month follow up |
|
|
Target Sample Size
|
Total Sample Size="136" Sample Size from India="136"
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 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
| Midline laparotomy incisions provide rapid access to the abdomen where keyhole surgery may be inadequate specially in emergency cases . Abdominal wall dehiscence incidence ranges between 2 and 5.5% after elective laparotomy and 8.5–45% after emergency laparotomy and typically occurs between the 6th and 12th postoperative day(1,5,6) Prophylactic use of antibiotics, mechanical bowel preparation, hair removal at the surgical site, skin disinfection, hand decontamination, and the use of sterile gloves and gowns are some of the recent advancements in the prevention of surgical site infections (SSIs). (7) Suture used for abdominal wall closure is another factor that may have an impact on SSI. The most current method for closing the abdominal fascia involves using absorbable monofilament sutures coated with triclosan. That being said, evisceration rates are elevated following unclean surgery and can up to 15% (8)In order to prevent segmental ischaemia, tissue necrosis, and secondary infection, it’s also critical to provide a uniform distribution of tension throughout the suture, as seen with barbed sutures (9) In a study done by Ruiz-Tovar et al found that TCB suture reduces the incidence of SSI and acute evisceration compared with standard fascial closure with triclosan-coated polydioxanone (PDS) looped suture and noncoated PDS looped suture in emergency nontraumatic laparotomy(10).The limitation of above study is suboptimal estimation of the SSI rate in the control group for the sample size calculation, might have led to a certain underpower of the study. The above study also did not include trauma laparotomy. There are no other randomized clinical trial study to support or refute the findings noted by Ruiz-Tovar et al .As far as we are aware, no research has examined the impact of closing abdominal fascia with barbed sutures following unclean surgery in Indian subcontinent. In this study, we are concentrating on a specific patient population: peritonitis due to hollow viscous perforation, who are more likely to experience wound degradation and surgical site infections. | |