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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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