| CTRI Number |
CTRI/2025/08/093507 [Registered on: 22/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two different stitches for closing the tummy after surgery and their effect on healing and recovery |
|
Scientific Title of Study
|
Suturing Smarter: Closure of Midline Laparotomy Using Barbed Polydioxanone Versus Conventional Polydioxanone – A Randomized Controlled Study |
| 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 LAVU JAYANTH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
ROOM 227, OPD BLOCK, DEPT OF GENERAL SURGERY, AIIMS MAGALAGIRI
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9849511547 |
| Fax |
|
| Email |
LAVUJAYANTH@AIIMSMANGALAGIRI.EDU.IN |
|
Details of Contact Person
Scientific Query
|
| Name |
DR LAVU JAYANTH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
ROOM 227, OPD BLOCK, DEPT OF GENERAL SURGERY, AIIMS MAGALAGIRI
ANDHRA PRADESH
522503
India |
| Phone |
9849511547 |
| Fax |
|
| Email |
LAVUJAYANTH@AIIMSMANGALAGIRI.EDU.IN |
|
Details of Contact Person
Public Query
|
| Name |
DR LAVU JAYANTH |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS MANGALAGIRI |
| Address |
ROOM 227, OPD BLOCK, DEPT OF GENERAL SURGERY, AIIMS MAGALAGIRI
ANDHRA PRADESH
522503
India |
| Phone |
9849511547 |
| Fax |
|
| Email |
LAVUJAYANTH@AIIMSMANGALAGIRI.EDU.IN |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR LAVU JAYANTH |
| Address |
ROOM 227, OPD BLOCK, DEPT OF GENERAL SURGERY, AIIMS MANGALAGIRI, GUNTUR, AP 522503 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 LAVU JAYANTH |
AIIMS MANGALAGIRI |
Room 227, second floor , opd block, Department of general Surgery, AIIMS MANGALAGIRI, GUNTUR , AP
Guntur
ANDHRA PRADESH
Guntur
ANDHRA PRADESH |
9849511547
LAVUJAYANTH@AIIMSMANGALAGIRI.EDU.IN |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
undergoing laparotomies |
| Patients |
, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Barbed group |
Barbed PDS suture for continuous, knotless fascial closure |
| Comparator Agent |
Non Barbed group |
Traditional monofilament suture i.e polydioxanone with continuous knot- anchored closure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Previous midline incision, ventral hernia- now planned only herniorrhaphy
Written informed consent |
|
| ExclusionCriteria |
| Details |
Emergency laparotomy
Immunocompromised states
Diabetes with poor glycemic control HbA1c over 8.5
Pregnant patients |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of wound dehiscence or SSI within 10 postoperative days |
Incidence of wound dehiscence or SSI within 10 postoperative days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Operative time for fascial closure (minutes) 2) Postoperative pain (VAS score) on POD 1, 3, 5 3) Incisional hernia at 3months, 6 months & 1 year (clinical & ultrasonographic evaluation) 4) Direct cost of suture material |
Postoperative pain (VAS score) on POD 1, 3, 5 3)
Incisional hernia at 3months, 6 months & 1 year (clinical & ultrasonographic evaluation) |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
26/09/2025 |
| Date of Study Completion (India) |
25/03/2026 |
| Date of First Enrollment (Global) |
26/09/2025 |
| Date of Study Completion (Global) |
25/03/2026 |
|
Estimated Duration of Trial
|
Years="1"
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
|
Midline laparotomy is widely used in abdominal surgeries, and proper abdominal wall closure is essential to prevent complications like surgical site infections, wound dehiscence, incisional hernias, and prolonged hospital stays. Traditionally, absorbable mnofilament sutures like polydioxanone (PDS) have been used for closure. Barbed sutures, which self-anchor without knots, offer potential benefits such as even tension distribution and reduced closure time. However, despite growing use, especially in laparoscopic and open procedures, there is limited high-quality evidence comparing barbed and traditional sutures—particularly in the Indian population. Concerns persist about barbed sutures’ long-term durability, cost-effectiveness, and risk of tissue trauma. This study seeks to fill these gaps through a rigorous randomized controlled trial |