| CTRI Number |
CTRI/2026/02/104946 [Registered on: 26/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| 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
|
A study on nasal healing after sinus surgery using steroid packing versus mitomycin packing |
|
Scientific Title of Study
|
Endoscpic image analysis of mucosal healing using triamcinolone and mitomycin-c nasal packing in functional endoscopic sinus surgery:A randomized double blinded clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrShalini Ramakrishna |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai veedu Medical College |
| Address |
Department Of ENT, Aarupadai veedu Medical College, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry, 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8660957289 |
| Fax |
|
| Email |
ravihukunda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrArul mozhi |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai veedu Medical College |
| Address |
Department Of ENT, Aarupadai veedu Medical College, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry, 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
9894261310 |
| Fax |
|
| Email |
Arulmozhi.jakanattane@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrShalini Ramakrishna |
| Designation |
Post Graduate |
| Affiliation |
Aarupadai veedu Medical College |
| Address |
Department Of ENT, Aarupadai veedu Medical College, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry, 607403
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8660957289 |
| Fax |
|
| Email |
ravihukunda@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shalini Ramakrishna |
| Address |
Department Of ENT, Aarupadai veedu Medical College, Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry, India |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Shalini Ramakrishna |
AARUPADAI VEEDU MEDICAL COLLEGE |
Room no: 9,C block, Department of ENT,Aarupadai veedu medical
college, Puducherry
Pondicherry
PONDICHERRY |
8660957289
ravihukunda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee, Aarupadai Veedu Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Endoscopic image analysis of mucosal healing using mitomycin -c nasal packing in functional endoscopic sinus surgery |
Patients undergoing functional endoscopic sinus surgery will receive postoperative nasal packing impregnated with mitomycin-C once. After completion of surgery and securing adequate hemostasis, sterile absorbable nasal packing material will be soaked in mitomycin-C solution and placed endoscopically in the operated nasal cavity, particularly in the middle meatus and around the sinus ostia and removed on post operative day 1. |
| Intervention |
Endoscopic image analysis of mucosal healing using triamcinolone |
Patients undergoing functional endoscopic sinus surgery will receive postoperative nasal packing impregnated with triamcinolone acetonide. Following completion of surgery and achievement of hemostasis, sterile absorbable nasal packing material will be soaked with triamcinolone acetonide solution and placed once endoscopically in the operated nasal cavity, specifically over the middle meatus and sinus openings and kept for 1day , removed on post operative day 1 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.)Diagnosed with chronic rhinosinusitis with/without polyps.
2.)Age 18-60 years.
3.)Scheduled for FESS.
4.)Willing to give informed consent. |
|
| ExclusionCriteria |
| Details |
1.)Previous nasal surgery.
2.)Known allergy to Triamcinolone or Mitomycin-C.
3.)Uncontrolled diabetes or bleeding disorders.
4.)Pregnancy/lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess post-operative symptom scores. |
Posyoperative day 1,day 10 ,day 30 and day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess post-operative symptom scores.
To evaluate incidence of synechiae & crusting.
|
Post operative day 1,day 10,day 30 & day 60 |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
26/02/2026 |
| 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="0"
Months="10"
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 - NO
|
|
Brief Summary
|
Functional endoscopic sinus surgery is commonly performed for chronic sinus disease. Postoperative mucosal healing plays an important role in surgical success and long term symptom relief. Poor healing may result in crusting adhesions or restenosis of sinus openings.
This randomized double blinded clinical trial is designed to compare mucosal healing following functional endoscopic sinus surgery using two different postoperative nasal packing agents triamcinolone and mitomycin C. Eligible patients undergoing sinus surgery will be randomly allocated to receive either triamcinolone impregnated nasal packing or mitomycin C impregnated nasal packing at the end of surgery. Both patients and outcome assessors will be blinded to the intervention.
Postoperative healing of the nasal mucosa will be evaluated using standardized endoscopic image analysis at predetermined follow up intervals. The study aims to assess epithelialization edema crusting and synechiae formation in both groups.
The results of this study may help identify the more effective nasal packing agent for improving mucosal healing and reducing postoperative complications following functional endoscopic sinus surgery.
|