| CTRI Number |
CTRI/2025/12/098821 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
04/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the safety and tolerability of an ear dressing, (VELNEZ® and a gelatin-based) applied after ear surgery. (Middle ear) |
|
Scientific Title of Study
|
A multi centric, Open label, double arm, randomized, comparative clinical study to evaluate safety and tolerability of VELNEZ® with Gelatin based space occupying dressing after middle ear surgery. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| DMPL/CIP-006-2025/CT/VN, Version 2.0, Dated 13-Mar-2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Pratap Singh |
| Designation |
Associate Professor |
| Affiliation |
S.N Medical College, Agra |
| Address |
Department of ENT & Head Neck surgery, S.N Medical College, Agra, UTTAR PRADESH 282002, India
S.N Medical College, Agra, UTTAR PRADESH 282002
Agra
UTTAR PRADESH
282002
India |
| Phone |
7895464858 |
| Fax |
|
| Email |
dr.akhilpratapsingh1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddharth Pandey |
| Designation |
Vice president & Head R and D |
| Affiliation |
Datt Mediproducts Pvt Ltd |
| Address |
Datt Mediproducts Pvt Ltd 52 to 54,63 and 64, Roz Ka Meo Industrial Area Nuh, Distt. Mewat, Gurgaon
HARYANA - 122103
Gurgaon
HARYANA
122103
India |
| Phone |
7290073669 |
| Fax |
|
| Email |
siddharth.pandey@dattmedi.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Bablani |
| Designation |
GM Clinical Research Operations |
| Affiliation |
Datt Mediproducts Pvt Ltd |
| Address |
Datt Mediproducts Pvt. Ltd. 56, Community Center, East of Kailash, New Delhi, 110065, India
South
DELHI
110065
India |
| Phone |
9315785417 |
| Fax |
|
| Email |
pankaj.bablani@dattmedi.com |
|
|
Source of Monetary or Material Support
|
| Datt Mediproducts Pvt. Ltd. is the sponsor in the trial. having its office located at, 56 Community Center,East of Kailash, New Delhi- 110065, India. The trial will also be insured |
|
|
Primary Sponsor
|
| Name |
Datt Meproducts Pvt Ltd |
| Address |
56 Community Center,East of Kailash, New Delhi- 110065 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Priti Hajare |
K.L.E.S. Dr. Prabhakar Kore Hospital & Medical Research Centre |
Nehru Nagar, Belagavi-590010, KARNATAKA
Belgaum
KARNATAKA |
9448117313
drpritihajare@gmail.com |
| Dr Akhil PartapSingh |
S.N. Medical College, Agra |
Department of ENT S.N.Medical College, Moti Katra,Agra - 282002 UTTAR PRADESH
Agra
UTTAR PRADESH |
895464858
dr.akhilpratapsingh1@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KLE University |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, SN Medical College, Agra |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, SN Medical College, Agra |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE, SN Medical College, Agra |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H73||Other disorders of tympanic membrane, (2) ICD-10 Condition: H73||Other disorders of tympanic membrane, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Gelatin based dressing |
A Sterile Compressed Sponge dressing that is absorbable |
| Intervention |
VELNEZ® |
VELNEZ® is a biodegradable composite dressing, designed to disintegrate within a few days of its application. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The participants must meet all the following criteria:
1. Male and female participants in the age group of 18 to 65 years. (Both Included).
2. Participant is confirmed diagnosis of inactive Chronic Suppurative Otitis Media (CSOM mucosal disease type).
3. Participant for the use of ear dressing pack (either VELNEZ® or Gelatin based dressing) in routine clinical practice after a planned otologic surgery for middle ear.
4. Participant who can provide informed consent form in writing or through his LAR.
5. Participants who are able and willing to comply with all study procedures and allow their study data to be collected at pre-defined follow-up period/ time and used for study objectives.
|
|
| ExclusionCriteria |
| Details |
The Participants must not meet any of the following criteria:
1. Participants who are unable to be treated with either VELNEZ® or Gelatin based dressing in routine clinical practice after a planned middle ear surgery.
2. Participant with a sign of active infection at the site of surgery [Presence of active middle ear infection or otorrhea (ear discharge).]
3. Participant having history of previous ear surgery on the same ear planned for the study procedure.
4. Participant with uncontrolled cholesteatoma, malignant otologic tumors, complications of chronic ear disease.
5. Participation in another interventional clinical trial within 30 days prior to screening or during the study period.
6. Pregnant and nursing women.
7. Participant with uncontrolled hypertension.
8. Participants who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the device (VELNEZ® / Gelatin based dressing) i.e., Chitosan, Gelatin and Psyllium husk etc.
9. Participant with bleeding disorders or is on anticoagulants or antiplatelet medications (e.g., warfarin, clopidogrel, NOACs).
10. Any medical condition that, in the opinion of the investigator, would make the participant unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) or Presence of severe systemic illness like cardiovascular disease, liver dysfunction or psychiatric illness.
11. Participant with history of postoperative recurrent infections and participants with bleeding diathesis.
12. Participant testing positive for serological markers indicating systemic infection (e.g., HIV, hepatitis B/C).
13. Participant with medical conditions known to impair healing, including:
• Uncontrolled diabetes mellitus. (HbA1c > 8%)
• Severe immunosuppression (Other than HIV/AIDS)
• Chronic systemic steroid use (>10 mg/day of prednisone or equivalent)
• Active malignancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) within 90 days post-surgery. |
90 ± 5 Days post surgery. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
• Change from baseline in Pure Tone Audiometry (PTA) parameters, including air-conduction thresholds & air–bone gap, assessed at Day 30, Day 60, & Day 90 post-surgery.
• Proportion of subjects demonstrating normal or improved middle-ear healing status, as assessed by standardized otoscopy findings & Impedance Audiometry parameters, on day 60 & 90.
• Proportion of participants achieving successful graft uptake, & granulation in the external auditory canal, defined as complete tympanic membrane closure, as assessed at Day 15, Day 30, Day 60, & Day 90 post-surgery.
|
90 ± 5 days post surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
05/05/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Middle ear surgeries—such as stapedotomy, tympanoplasty, and myringotomy—require careful postoperative management to ensure optimal healing and restoration of auditory function. Maintaining a clean, dry, and microbe-free ear canal is essential, as moisture and irritants can hinder recovery. Traditional postoperative dressings often adhere strongly to the wound bed, which may cause reactive bleeding and increase the risk of infection during removal. To overcome these limitations, the VELNEZ® space-occupying dressing pack has been introduced as an innovative alternative. VELNEZ® is a biodegradable composite that naturally disintegrates within a few days of placement, eliminating the need for painful or traumatic removal. Its design supports reduced fibrosis, enhanced healing, and improved clotting, contributing to smoother postoperative outcomes in middle ear surgeries. In contrast, gelatin-based dressings are sterile, compressed, porcine-derived absorbable sponges used primarily as hemostatic agents. They effectively control capillary, venous, and arteriolar bleeding when conventional methods are insufficient. These dressings are water-insoluble, pliable, and easily cut without fraying. Their high absorbency allows them to take up several times their weight in blood, promoting clot formation and gradual absorption within tissue without significant tissue reaction. |