| CTRI Number |
CTRI/2024/12/078361 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Easy to wear vest dressing for the trunk burn injury |
|
Scientific Title of Study
|
Innovative easy to wear vest dressing for the trunk - A prospective study assessing a Multi-Layered Dressing Combining Nano Silver, Foam, and Activated Charcoal |
| 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. SHIVANGI SAHA |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no. 213, Second Floor Department of Plastic,Reconstructive & Burns Surgery, All India Institute of Medical Sciences, Ansari Nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
9968969174 |
| Fax |
|
| Email |
shivangisaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. SHIVANGI SAHA |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no. 213, Second Floor Department of Plastic,Reconstructive & Burns Surgery, All India Institute of Medical Sciences, Ansari Nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
9968969174 |
| Fax |
|
| Email |
shivangisaha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. SHIVANGI SAHA |
| Designation |
Assistant Professor |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
Room no. 213, Second Floor Department of Plastic,Reconstructive & Burns Surgery, All India Institute of Medical Sciences, Ansari Nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
9968969174 |
| Fax |
|
| Email |
shivangisaha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of plastic Reconstructive & Burns Surgery All India Institute of Medical Sciences New Delhi |
|
|
Primary Sponsor
|
| Name |
Triage Meditech Pvt Ltd |
| Address |
D14/7, Pocket-D,Phase 1, Okhla Industrial Estate, New Delhi
Delhi Pin code 110020 |
| Type of Sponsor |
Other [Specializing in the manufacturing and distribution of wound care solutions. ] |
|
|
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 Shivangi Saha |
All India Institute of Medical Sciences |
ICU and ward, Burns and Plastic Surgery Block, Department of Plastic Reconstructive and Burns Surgery AIIMS Ansari Nagar New Delhi 110029
New Delhi
DELHI |
9968969174
shivangisaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: X141||Other contact with hot air and other hot gases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Adult burn patients (aged 18+) with a BMI (≥23) and trunk injuries requiring dressing changes.
2) Degree of burn should be Second and Third degree.
|
|
| ExclusionCriteria |
| Details |
1) Patients with known allergies to any materials used in the dressing and associated skin disease.
2) Patients requiring specialized dressings or treatment protocols that differ from the study intervention.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcomes:
1. Time to wound healing as per Bates Jensen score.
2. Pain during the intervention will be assessed using Visual Analog Scale (VAS).
|
1. The wound healing will also be assessed at each dressing on Bates Jensen scoring system. The dressing change will happen on day 0, 3,7,11,15 and 21 depending upon the wound exudate.
2.At the time of dressing between day 3-5 patients pain during dressing will recorded on a visual analog scale between 0-10, need for any pain killer during the dressing will also be recorded.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Frequency of dressing will be measured.
2. Health care provider comfort with dressing application will be assessed |
Patient will be dressed using innovative wound dressing for the vest dressing will be applied on day 0 and changed on day 3-5, based upon the soakage. At the time of the dressing application the ease of dressing will be recorded on a likert scale by health care providers |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
28/12/2024 |
| 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="1"
Days="1" |
|
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
|
Patients meeting the inclusion criteria will be recruited in the study and the first dressing will be done when the patients reports to the Burns emergency, wound will be cleaned with the normal saline then patient will be recruited consecutively recruited in the Group 1 and Group 2. In Group 1 they will be dressed using innovative wound dressing for the vest the dressing will be applied on day 0, and changed on day 3-5 based upon the soakage, at the time of the dressing application the ease of dressing will be recorded on a Likert scale by the health care provider. At the time dressing between day 3-5 patients pain levels during dressing change will be recorded on a VAS scale between 0-10, need for any pain killer during the dressing will also be recorded, The wound healing will also be assessed at each dressing on Bates Jensen scoring system. The dressing change will happen on day 0, 3, 7,11 15, 21 depending upon the wound exudates, if the wound is deep and the patients need the surgical intervention then the details of the surgical intervention will also be recorded and even after surgical intervention same dressing will be continued. |