| CTRI Number |
CTRI/2026/03/105672 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Study to Compare Two Different types of Surgical Stitches Used To Close Abdominal Wound |
|
Scientific Title of Study
|
Efficacy Of Barbed Sutures Versus Delayed Absorbable Polydiaoxanome Sutures in Abdominal Sheath Closure A Randomised Control 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 |
Hardeep Singh |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ramdas university of health sciences |
| Address |
Surgery unit 6 , 2nd floor , south division , room no.4
SGRD, VALLAH , AMRITSAR
Amritsar
PUNJAB
143005
India |
| Phone |
9079764059 |
| Fax |
|
| Email |
hardeepsinghhmh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohit Sharma |
| Designation |
Professor General Surgery |
| Affiliation |
Sri Guru Ramdas university of health sciences |
| Address |
Surgery unit 6 , 2nd floor , south division , room no.2
SGRD, VALLAH , AMRITSAR
Amritsar
PUNJAB
143005
India |
| Phone |
9814651788 |
| Fax |
|
| Email |
drmohit.gis@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohit Sharma |
| Designation |
Professor General Surgery |
| Affiliation |
Sri Guru Ramdas university of health sciences |
| Address |
Surgery unit 6 , 2nd floor , south division , room no.2
SGRD, VALLAH , AMRITSAR
Amritsar
PUNJAB
143005
India |
| Phone |
9814651788 |
| Fax |
|
| Email |
drmohit.gis@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Guru Ramdas University of Health Sciences |
| Address |
Department of Surgery Sri Guru Ramdas University of Health Sciences amritsar punjab 143001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| 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 Hardeep Singh |
Sri Guru Ramdas charitable hospital, vallah |
ROOM NUMBER 2, SURGERY SECOND FLOOR, UNIT 6, SGRDUHS, VALLAH
Amritsar
PUNJAB |
9079764059
hardeepsinghhmh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, (2) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Barbed suture
|
Closure of abdominal sheath with barbed suture followed up for 3 months. |
| Comparator Agent |
Delayed Absorbable Polydiaoxanone Suture |
Closure of Abdominal sheath with delayed absorbable polydioxanone suture followed up for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 65 years undergoing elective midline laparotomy requiring abdominal sheath closure.
2.American Society of Anaesthesiologists (ASA) physical status classification I to III Patients. 3.who provide informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Emergency surgeries
2.Patients with previous abdominal wall surgery in the same region
3.Known connective tissue disorders (e.g., Ehlers-Danlos syndrome)
4.Active infection at the surgical site or systemic sepsis
5.Immunocompromised patients (e.g., HIV, on immunosuppressive therapy)
6.Allergy or known hypersensitivity to suture materials used
7.Pregnant women |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the post-operative parameters following abdominaL sheath
closure using barbed sutures versus delayed absorbable polydioxanone sutures in terms
of
1.Occurance of SSI
2.Occurance of seroma
3.Occurance of wound dehiscence |
4.Post operative 1st day
5.post operative 3rd day
6.post operative 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Post operative pain using VAS scale
2.Total time taken for abdominal sheath closure
3.Incisional hernia development at 3 months post-surgery
4.Suture material cost |
1.Post operative 1st day
2.post operative 3rd day
3.post operative 7th day
4.post operative 3rd month |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
17/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Abdominal sheath closure is a critical step in abdominal surgeries to ensure
proper wound healing and prevent complications such as wound dehiscence and incisional
hernia. Traditionally, delayed absorbable sutures like polydioxanone (PDS) have been widely
used for this purpose due to their strength and prolonged absorption time. Recently, barbed
sutures have gained attention for their knotless design, which potentially reduces operative
time and distributes tension evenly along the wound. This study aims to compare the
effectiveness and outcomes of barbed sutures with delayed absorbable polydioxanone sutures
for abdominal sheath closure. |