| CTRI Number |
CTRI/2024/04/066508 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/04/2024 |
| 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
|
Early healing and granulation of wound using new dressing technique with dehydrated human amnion, chronic and phmb on patient with chronic non healing ulcers which are not healing easily after normal dressing. |
|
Scientific Title of Study
|
Comparison of conventional normal saline dressing with dehydrated human amnion and chorion powder and polyhexamethylene bigunamide dressing in management of chronic non healing, infectious wounds |
| 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 Balwant Negi |
| Designation |
Associate Professor |
| Affiliation |
Atal Medical and Research University Himachal Pradesh |
| Address |
Department of General Surgery Indira Gandhi Medical College Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418057958 |
| Fax |
|
| Email |
drbalwantnegi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balwant Negi |
| Designation |
Associate Professor |
| Affiliation |
Atal Medical and Research University Himachal Pradesh |
| Address |
Department of General Surgery Indira Gandhi Medical College Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418057958 |
| Fax |
|
| Email |
drbalwantnegi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balwant Negi |
| Designation |
Associate Professor |
| Affiliation |
Atal Medical and Research University Himachal Pradesh |
| Address |
Department of General Surgery Indira Gandhi Medical College Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418057958 |
| Fax |
|
| Email |
drbalwantnegi@gmail.com |
|
|
Source of Monetary or Material Support
|
| INDIRA GANDHI MEDICAL COLLEGE SHIMLA HIMACHAL PRADESH |
|
|
Primary Sponsor
|
| Name |
Dr Shubham Sharma |
| Address |
Indira Gandhi Medical College Shimla Himachal Pradesh |
| 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 |
| Shubham Sharma |
INDIRA GANDHI MEDICAL COLLEGE SHIMLA |
GENERAL SURGERY DEPARTMENT
Shimla
HIMACHAL PRADESH |
8107171105
drshubhamsharma25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE IGMC SHIMLA |
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 |
Dressing on Chronic non healing wounds with dehydrated human amnion, chorion and polyhexamethylene bigunamide dressing in management of chronic non healing infectious wounds |
Time duration of 3 days |
| Comparator Agent |
Normal Saline dressing |
Time duration of 3 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronic non healing ulcers |
|
| ExclusionCriteria |
| Details |
Age less than 16 years and more than 60 years
Ulcers associated with Wagner grade IV and V
Ulcers associated with collagen vascular disorders
Patient on medications like corticosteroids, immunosuppressant, chemotherapy
Immunocompromised patient
Pregnant or nursing mothers
Patient not willing or in between study patient opt for drop out |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in wound area in centimetre square, time taken for appearance of granulation tissues in days, time taken for complete granulation tissue to form in days, duration of treatment in days, comparison in conventional normal saline dressing with dehydrated human amniotic, chorion and phmb dressing. |
After 3 days, 1 week, 2 weeks, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Wound complications like necrosis, skin excoriation |
1 month |
|
|
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
09/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
09/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - On request it will be provided
- For how long will this data be available start date provided 01-07-2024 and end date provided 30-09-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Patient admitted in surgery department ward of INDIRA GANDHI MEDICAL COLLEGE, SHIMLA will be taken for the study after taking consent and telling them about the study. |