| CTRI Number |
CTRI/2026/01/101962 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Advanced vacuum therapy compared to traditional dressings in healing wounds |
|
Scientific Title of Study
|
Comparative study of vacuum assissted closure dressings versus conventional dressings in wound management |
| 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 Jasjot Singh Bhullar |
| Designation |
Junior resident |
| Affiliation |
Sri Guru Ram Das University of Health Sciences |
| Address |
Department of General Surgery Sri Guru Ram Das University of Health Sciences Vallah Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
9529816677 |
| Fax |
|
| Email |
jbhullar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rana Ranjit Singh |
| Designation |
Professor and Head General Surgery |
| Affiliation |
Sri Guru Ram Das University of Health Sciences |
| Address |
Department of General Surgery Sri Guru Ram Das Institute of Medical Sciences and Research Vallah Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
919876151548 |
| Fax |
|
| Email |
gurveer1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rana Ranjit Singh |
| Designation |
Professor and Head General Surgery |
| Affiliation |
Sri Guru Ram Das University of Health Sciences |
| Address |
Department of General Surgery SriGuru Ram Das University of Health Sciences Vallah Amritsar
Amritsar
PUNJAB
143501
India |
| Phone |
919876151548 |
| Fax |
|
| Email |
gurveer1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Guru Ram Das University of Health Sciences Vallah Amritsar Punjab India 143501 |
|
|
Primary Sponsor
|
| Name |
Department of general surgery |
| Address |
Sri Guru Ram Das University of Health Sciences Vallah Amritsar Punjab India 143501 |
| Type of Sponsor |
Private 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 Rana Ranjit Singh |
Sri Guru Ram Das University of Health Sciences Vallah Amritsar |
Department of General Surgery
Amritsar
PUNJAB |
98761 51548
gurveer1@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: L979||Non-pressure chronic ulcer of unspecified part of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional dressings |
Simple conventional wound dressings for 5 days and then till 2 weeks |
| Intervention |
Vacuum assissted closure dressings |
Dressings done with Vacuum assissted closure for 5 days and then serial dressings |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Diabetic foot ulcers
Chronic Non healing wounds |
|
| ExclusionCriteria |
| Details |
Wounds with necrotic tissue
Untreated underlying osteomyelitis
Wounds with recorded bone nerve tendon
Wounds with unstable fracture or loose fragments in bone
Malignancy in the wound |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to complete wound healing (in days) comparing vacuum assisted closure dressings with conventional dressings. |
Baseline
5 days
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of wound size reduction (cm²/week). |
Baseline
5 days
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
05/02/2026 |
| 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) |
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
|
Wound healing remains a major clinical challenge particularly in chronic and complex wounds. Vacuum assisted closure therapy is a promising modality that enhances wound healing by promoting granulation tissue formation and reducing infection risk compared to conventional dressings. This randomized comparative study aims to evaluate and compare the rate of wound healing between vacuum assisted closure dressings and conventional dressings in patients with chronic non healing wounds. |