| CTRI Number |
CTRI/2024/06/069152 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
16/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A randomized clinical study to compare patient satisfaction and clinical outcome with three different nasal pack dressings available and that are used after nasal surgery |
|
Scientific Title of Study
|
An open-labelled, Prospective, three arm, single center, randomized clinical study to compare patient satisfaction and clinical outcome associated with available nasal packs in nasal surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SNMC/CIP-001-2023/IIS/VN, Version 1.0; Date 01-Nov-2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhil Partap Singh |
| Designation |
Associate professor ENT Dept |
| Affiliation |
Department of ENT |
| Address |
Department of ENT,
S N Medical College
Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
7895464858 |
| Fax |
|
| Email |
researchsnmc111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akhil Partap Singh |
| Designation |
Associate professor ENT Dept |
| Affiliation |
Department of ENT |
| Address |
Department of ENT
S N Medical College
Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
7895464858 |
| Fax |
|
| Email |
researchsnmc111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akhil Partap Singh |
| Designation |
Associate professor ENT Dept |
| Affiliation |
Department of ENT |
| Address |
Department of ENT
S N Medical College
Agra
Agra
UTTAR PRADESH
282003
India |
| Phone |
7895464858 |
| Fax |
|
| Email |
researchsnmc111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Investigator initiated trial, patients would be from OPD, Department of ENT, S.N medical college, Agra |
|
|
Primary Sponsor
|
| Name |
Dr Akhil Pratap Singh Trial Investigator |
| Address |
Dept. of ENT, S.N Medical College, Agra. |
| 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 |
| Dr AKHIL PRATAP SINGH |
S. N Medical College, Agra |
Department of ENT,
SN Medical College, Agra
Agra
UTTAR PRADESH |
7895464858
researchsnmc111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: J32||Chronic sinusitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MEROCEL manufactured by Medtronic. |
Merocel is a compressed, dehydrated sponge composed of hydroxylated polyvinyl acetate. They are highly absorbent, providing effective hemostasis by exerting pressure on the nasal. Total trial duration wound be, 3 weeks. |
| Comparator Agent |
RAPID RHINO manufactured by Smith & Nephew, UK |
RAPID RHINO portfolio with its exclusive formulation of Carboxymethyl Cellulose (CMC), a plant-derived material. When in contact with water, CMC forms a cushioning hydrocolloid gel. Natural CMC Technology offers multiple patient care advantages, giving healthcare professionals the utmost confidence. These are inflatable nasal tampons made of latex-free material. They are inserted into the nasal cavity and inflated with air or saline to exert pressure on the nasal mucosa for hemostasis. Rapid Rhino packs come in various sizes and configurations to accommodate different surgical procedures and patient anatomy. They are easy to insert and remove, providing effective hemostasis with minimal patient discomfort. Total trial duration wound be, 3 weeks. |
| Comparator Agent |
VELNEZ manufactured by Datt Mediproducts Pvt. Ltd.India |
VELNEZ is a biodegradable composite that fragments within few days on application and intended as nasal pack. It contains Gelatin, Chitosan, Polyvinyl Alcohol, Psyllium Husk. Total trial duration wound be, 3 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject eligible for the use of a nasal pack (either VELNEZ, Merocel or Rapid Rhino) in routine clinical practice after a planned nasal surgery.
2. Male and female in the age group of 18 to 70 years. (Both Included)
3. Subjects who can provide informed consent form in writing.
4. Subjects who allow their study data to be collected at pre-defined follow-up period. |
|
| ExclusionCriteria |
| Details |
1. Subject who are unable to be treated with the other than VELNEZ, Merocel or Rapid Rhino nasal pack in routine clinical practice after a planned nasal surgery.
2. Subject unwilling or unable to comply with the postoperative visits necessary for data collection.
3. Subject with an active infection at the surgery site.
4. Subject with a history of asthma.
5. Subject who are on aspirin or anti-platelet drugs therapy.
6. Hypertensive subjects.
7. Subjects who have a history of allergy (Hypersensitive) reactions with any of the ingredients of the nasal pack.
8. Subject with bleeding disorders.
9. Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g., a chronic, relapsing or hereditary disease that may interfere with the outcome of the study) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the efficacy of the nasal packs (VELNEZ, Merocel, or Rapid Rhino) in ceasing reactive bleeding and achieving secondary bleeding control in post-operative nasal surgery patients. This will be evaluated based on the duration and extent of bleeding cessation observed with each nasal pack.
The assessment of synechiae formation among the various nasal pack groups. The presence and extent of adhesions between the nasal mucosa and other structures will be evaluated to determine the incidence of synechiae formation.
The assessment of safety based on adverse events reported with the application of the nasal packs used. Any adverse reactions, complications, or adverse events related to the use of nasal packs will be documented and compared between the different nasal pack groups. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient-reported discomfort associated with the use of nasal packs post-surgery is an important endpoint. This will include assessing discomfort caused by the presence of the nasal pack, discomfort during its removal (including pressure and pain), and overall discomfort experienced by patients during the post-operative period.
Evaluation of bleeding through the nose following the removal of nasal packs will provide insights into the effectiveness of hemostasis and bleeding control achieved by each nasal pack type.
Assessment of crust formation and adhesion to the nasal mucosa at 2 weeks post-surgery will provide information on the healing process and potential complications associated with each nasal pack type. |
3 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
27/06/2024 |
| Date of Study Completion (India) |
30/04/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The use of nasal dressings is a critical component in the management of various nasal conditions, providing support, hemostasis, and localized treatment. Careful consideration of the type and duration of packing, along with monitoring for complications, is essential for optimal patient outcomes. This is an investigator-initiated trial here, all subjects planned for nasal surgery and requiring nasal packing post-surgery will be enrolled after taking their permission to participate in the study and after obtaining their written consent. Each participant will be assigned a treatment (Merocel, Rapid Rhino, or Velnez) |