| CTRI Number |
CTRI/2023/02/049434 [Registered on: 03/02/2023] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the effectiveness of dressing (VELNEZ) after ear surgery. |
|
Scientific Title of Study
|
A post marketing surveillance (PMS), single centric study to evaluate safety and tolerability of VELNEZ as
a space occupying dressing pack after ear surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DMPL/CIP-006-2022/CT/VN, version 01, date 04-Oct-2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Pratap Singh |
| Designation |
Assistant Professor |
| Affiliation |
S.N.Medical College |
| Address |
Department of ENT,
S.N.Medical College,
Moti Katra,
Agra
UTTAR PRADESH
282003
India |
| Phone |
7895464858 |
| Fax |
|
| Email |
dr.akhilpratapsingh1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Vice President (R&D) |
| Affiliation |
Datt Mediproducts Private Limited |
| Address |
56 community center,
East of Kailash,
South
DELHI
110065
India |
| Phone |
9871011002 |
| Fax |
|
| Email |
lifescience@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
General Manager Clinical Research |
| Affiliation |
Datt Mediproducts Private Limited |
| Address |
56 community center,
East of Kailash,
South
DELHI
110065
India |
| Phone |
09999059412 |
| Fax |
|
| Email |
clinical@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| Datt mediproducts private limited,
56-Community center,
East of Kailash,
New Delhi
110065 |
|
|
Primary Sponsor
|
| Name |
Datt Mediproducts Private Limited |
| Address |
56 community center,
East of Kailash, New Delhi |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Akhil pratap singh |
S.N. Medical College |
Department of ENT,
S.N. Medical College,
Moti Katra,
Agra
UTTAR PRADESH |
07895464858
dr.akhilpratapsingh1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee S.N Medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H61||Other disorders of external ear, (2) ICD-10 Condition: H74||Other disorders of middle ear mastoid, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
N/AP |
| Intervention |
VELNEZ |
space occupying dressing pack to be applied once during the trial. (Post surgery) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject eligible to receive the ear plug in routine clinical practice after planned ear surgery (External and middle ear surgeries).
2. subjects of any sex of age between 18-60 years. (Both included).
3. Subjects who can give informed consent in writing for participation in the trial.
4. Subjects allowing their data to be collected for the study at predefined followups.
5. Female subject who is willing to take contraception for the entire duration of the study. |
|
| ExclusionCriteria |
| Details |
1. Subject who cannot be treated with ear plug after planned ear surgery.
2. Subjects who cannot provide informed consent.
3. Subject found positive for HIV, HBsAg and HCV.
4. Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
5. Subjects suffering from cholesteatoma or granulations in the middle ear.
6. Subjects suffering from complicated chronic suppurative otitis media.
7. Subject having an active infection at the surgical site.
8. Subjects having a history of diabetes mellitus.
9. Subject on aspirin/anti-platelet drugs /oral anticoagulants therapy.
10. Hypertensive subject.
11. Pregnant females.
12. Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e., Chitosan, Gelatin and Psyllium husk etc.
13. Concurrent participation in another clinical trial that involves an investigational drug or dressing that would interfere with this study.
14. Subject with Immunosuppression, corticosteroids or chemotherapy.
15. Subject with decision making impairment.
16. Subject with a severe comorbid disorder, not expected to survive more than 12 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Study participant who does-not achieve disintegration of the dressing/ ear plug within 49 days.
• Study participants who does-not achieve complete hemostasis with 20 minutes.
• Study participant whose dressing got removed before the study period. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Proportion of population having moderate pain.
• Proportion of population having infection at surgery site.
• Population experiencing pressure effect in the ear canal, due to the application of the VELNEZ ear plug. |
60 days |
|
|
Target Sample Size
|
Total Sample Size="21"
Sample Size from India="21"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
13/02/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The adhesive properties of a dressing could lead to reactive and secondary bleeding in the ear canal, leading to post-operative infections. This ear packing is used in the external and middle ear surgery. The pain associated with removal procedures is not necessary on application of VELNEZ. Also reduces fibrosis at the same time promote healing and clotting. The study has been conducted to assess the effectiveness of a VELNEZ (space occupying dressing pack) after ear surgery on the basis of its healing rate on clinical evaluation and wound analysis. |