CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2026/01/101566 [Registered on: 19/01/2026] Trial Registered Prospectively

Last Modified On:

16/01/2026

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

Comparison of two nasal packing materials used after septoplasty.

Scientific Title of Study

A Randomized comparative study evaluatingpost-septoplasty sequelae using Merocel versus chitosan-coated Merocel nasal packing.

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 V Srinivasa
Designation	Professor and Head of Department
Affiliation	Vinayaka missions medical college and Hospital
Address	Department of Otorhinolaryngology-Head and Neck Surgery, Vinayaka Missions Medical College and Hospital. Keezhakasakudi medu, Kotucherry post, Karaikal,Puducherry,India. Keezhakasakudi medu, Kotucherry post, Karaikal,Puducherry,India. Karaikal PONDICHERRY 609609 India
Phone	9842774997
Fax
Email	vemsrigeenan2@gmail.com

Details of Contact Person
Scientific Query

Name	DR V Srinivasa
Designation	Professor and Head of Department
Affiliation	Vinayaka missions medical college and Hospital
Address	Department of Otorhinolaryngology-Head and Neck Surgery, Vinayaka missions medical college and Hospital, Keezhakasakudi medu, Kotucherry post, Karaikal,Puducherry,India. Keezhakasakudi medu, Kotucheery post, Karaikal,Puducherry,India. Karaikal PONDICHERRY 609609 India
Phone	9842774997
Fax
Email	vemsrigeenan2@gmail.com

Details of Contact Person
Public Query

Name	DR V Srinivasa
Designation	Professor and Head of Department
Affiliation	Vinayaka missions medical college and Hospital
Address	Vinayaka missions medical college and Hospital, Keezhakasakudi medu, Kotucherry post, Karaikal,Puducherry,India. Keezhakasakudi medu, Kotucherry post, Karaikal,Puducherry,India. Karaikal PONDICHERRY 609609 India
Phone	9842774997
Fax
Email	vemsrigeenan2@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Department of Otorhinolaryngology
Address	Vinayaka missions medical college and Hospital. Keezhakasakudi medu, Kotucherry post, Karaikal,Puducherry,India.
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR M KARTHICK YOGESH	Department of Otorhinolaryngology	Vinayaka missions medical college and Hospital, Keezhakasakudi medu, Kotucherry post, Karaikal,Puducherry,India. Karaikal PONDICHERRY	7695948015 karthickyogesh96@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: J342\|\|Deviated nasal septum,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Chitosan coated Merocel nasal pack.	Chitosan ccoated Merocel nasal packing will be placed bilaterally after septoplasty surgery and will be removed after 24 hours.
Comparator Agent	Conventional Merocel nasal pack.	Conventional Merocel nasal pack will be placed bilaterally after septoplasty surgery and will be removed after 24 hours.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	Patients aged 18 to 60 years undergoing septoplasty for deviated nasal septum will be included. Patients willing to participate in the study and provide written informed consent will be included.

ExclusionCriteria

Details

PATIENTS WITH AGE LESS THA 18 YEARS OF AGE.
ACTIVE INFECTIONS.
REVISION SURGERY PATIENTS.
PATIENTS WITH SEA FOOD ALLERGY.
PREGNANT WOMEN AND BREAST FEEDING PATIENTS.
PATIENTS WITH SINONASAL TUMORS OR OBSTRUCTIVE LEISIONS.
PATIENT NOT WILLING FOR THE STUDY.

Method of Generating Random Sequence

Stratified block randomization

Method of Concealment

Alternation

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To check the incidence of post-operative synechiae formation,pain assessment and wound site infection following septoplasty surgery.	Patients will be assessed on Post-operative days 1,5,21 and 35.

Secondary Outcome

Outcome	TimePoints
POST OPERATIVE PAIN AND WOUND INFECTION.	ASSESSMENTS MADE ON DAY 1,5,21,35.

Target Sample Size

Total Sample Size="52"
Sample Size from India="52"
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)

25/04/2026

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

This study is a prospective comparative study conducted to evaluate the effectiveness of chitosan-coated Merocel nasal packing compared to conventional Merocel nasal packingin patients undergoing septoplasty,The primary outcomes include postoperative synechiae formation.Secondary outcomes include pain assessment and wound site infection.The study aims to dtermine whether chitosan-coated Merocel nasal packing provides better postoperative outcomes following septoplasty surgery.