| CTRI Number |
CTRI/2025/12/098672 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/12/2025 |
| 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
|
Comparison of Polydioxanone and Polypropylene Sutures for small and medium Peripheral Vascular Anastomosis: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Comparative study between polydioxanone and polypropylene sutures in peripheral small and medium vascular anastomoses: A Randomised 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 |
Palak Pun |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Aiims Rishikesh, Rishikesh, Dehradun, Uttarakhand
Department of CTVS, Aiims Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7018903504 |
| Fax |
|
| Email |
palakpun28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pardeep Kumar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
Aiims Rishikesh, Rishikesh, Dehradun, Uttarakhand
Department of CTVS, Aiims Rishikesh, Dehradun, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8082328133 |
| Fax |
|
| Email |
residentpardeep07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Palak Pun |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Rishikesh |
| Address |
Aiims Rishikesh, Rishikesh, Dehradun, Uttarakhand
Department of CTVS, Aiims Rishikesh, Dehradun, Uttarakhand
UTTARANCHAL
249203
India |
| Phone |
7018903504 |
| Fax |
|
| Email |
palakpun28@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
AIIMS Rishikesh, Dehradun, Uttarakhand |
| 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 Palak Pun |
AIIMS Rishikesh |
CTVS Department, AIIMS Rishikesh, Shivaji Nagar, Veerbhadra road, Rishikesh, Dehradun,
Dehradun
UTTARANCHAL |
7018903504
palakpun28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh, Institutional Ethics committee |
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 |
Polydioxanone |
Arm A: Use Polydioxanone suture in peripheral vascular anastomoses |
| Comparator Agent |
polypropylene |
Arm B: use of Polypropylene suture in peripheral vascular anastomoses
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. age more than 18 years
2. vessel size more than 2mm |
|
| ExclusionCriteria |
| Details |
1. age less than 18 years
2. vessel size less than 2mm |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in patency rates and pseudoaneurysm formation in patients undergoing peripheral vascular anastomoses as compared to the results with conventional suture |
2 weeks, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
22/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/12/2025 |
| 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) |
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
|
peripheral vascular anastomoses is conventionally done using non absorbable sutures, Polypropylene. Polypropylene, non absorbable suture is a foreign material and may lead to foreign body reaction causing infection and leading to dehiscence of anastomosis leading pseudo aneurysm formation. Absorbable sutures, Polydioxanone, however degrades after 6 weeks and does not lead to foreign body reaction. Polydioxanone is widely used in central vascular anastomoses, in TAPVC repair in pediatric population and is found safe. This study will compare safety and efficacy of Polypropylene that is conventionally used with Polydioxanone use in peripheral vascular anastomoses. |