- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07663929
Nasal Packing After Turbinoplasty
June 18, 2026 updated by: Ahmed Magdi Noaman Othman Orabi, Kafrelsheikh University
Nasal Packing After Turbinoplasty, Is it Worthwhile? A Prospective Study ?
This study aims to to compare postoperative pain, patient comfort, and hemostatic safety among four non-absorbable nasal packing techniques following microdebrider-assisted inferior turbinoplasty (MAIT) and to identify the most effective low-cost packing option.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Procedure: Standard bilateral Merocel® nasal tampons packing after Microdebrider-assisted inferior turbinoplasty
- Procedure: A Merocel® tampon was enclosed within the finger portion of a sterile powder-free latex surgical glove after Microdebrider-assisted inferior turbinoplasty
- Procedure: Merocel® tampons were coated with a thin uniform layer of topical broad-spectrum antibiotic ointment after microdebrider-assisted inferior turbinoplasty
- Procedure: terile ribbon gauze impregnated with white petroleum jelly (paraffin) after microdebrider-assisted inferior turbinoplasty
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Kafrelsheikh, Egypt
- Kafrelsheikh University Hospitals
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adults aged 18-65 years.
- Chronic bilateral nasal obstruction secondary to inferior turbinate hypertrophy.
- Failure of conservative medical management for at least 3 months, including intranasal corticosteroids and oral antihistamines.
- Positive decongestion test showing ≥30% improvement in anterior nasal cavity volume (V2-5 cm) on acoustic rhinometry after topical xylometazoline 0.5%, confirming predominantly mucosal rather than bony hypertrophy.
- Inferior turbinate hypertrophy grade 3 or 4 according to the Camacho classification system.
Exclusion Criteria:
- Significant nasal septal deviation affecting the nasal valve region.
- Internal or external nasal valve collapse or stenosis.
- Chronic rhinosinusitis with or without nasal polyposis.
- Previous nasal or paranasal sinus surgery.
- Coagulopathy or current anticoagulant therapy.
- Uncontrolled systemic disease.
- Pregnancy.
- Active smoking.
- Known allergic sensitization to any component of the nasal packing materials.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard bilateral Merocel® nasal tampons
|
Standard bilateral Merocel® nasal tampons (Medtronic, USA) were inserted in their dry compressed form.
Prior to insertion, each tampon was trimmed according to the dimensions of the patient's nasal cavity.
Following contact with nasal secretions, the Merocel expanded to provide gentle and uniform pressure over the operative site.
|
|
Active Comparator: A Merocel® tampon enclosed within the finger portion of a sterile powder-free latex surgical glove
|
A Merocel® tampon was enclosed within the finger portion of a sterile powder-free latex surgical glove.
The glove finger was then partially stripped to expose portions of the Merocel surface while retaining a thin latex interface, thereby preventing the glove from acting as a complete barrier and allowing contact between the Merocel and surrounding nasal secretions.
This modification preserved the expansion and absorptive properties of the Merocel while creating a smoother, less adherent outer surface.
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|
Active Comparator: Merocel® tampons were coated with a thin uniform layer of topical broad-spectrum antibiotic ointment
|
Merocel® tampons were coated with a thin uniform layer of topical broad-spectrum antibiotic ointment, such as fusidic acid 2% plus corticosteroids, prior to bilateral insertion.
This modification was intended to provide localized antimicrobial coverage while preserving the hemostatic effect of the packing material.
|
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Active Comparator: sterile ribbon gauze impregnated with white petroleum jelly (paraffin)
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Sterile ribbon gauze impregnated with white petroleum jelly (paraffin) was loosely packed into each nasal cavity in a layered accordion-like fashion, beginning at the nasal floor and progressing posteriorly.
Packing density was standardized to achieve adequate hemostasis while avoiding excessive pressure on the nasal mucosa.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: We assesed pain during first 48 hours postoperative.
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1.Pain intensity Assessed using the Visual Analogue Scale (VAS) (0 = no pain, 10 = worst imaginable pain)
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We assesed pain during first 48 hours postoperative.
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Bleeding after packing removal Assessed using a 4-point grading scale
Time Frame: We assesed bleeding immediately after nasal packing removal
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Grade 0 = no bleeding Grade 1 = oozing Grade 2 = continuous bleeding Grade 3 = bleeding requiring intervention or control in the operating room
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We assesed bleeding immediately after nasal packing removal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nasal fullness/pressure sensation
Time Frame: We assesed it during first 48 hours postoperative.
|
Nasal fullness/pressure sensation Assessed using the Visual Analogue Scale (VAS; 0-10)
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We assesed it during first 48 hours postoperative.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2026
Primary Completion (Actual)
May 6, 2026
Study Completion (Actual)
June 3, 2026
Study Registration Dates
First Submitted
June 14, 2026
First Submitted That Met QC Criteria
June 18, 2026
First Posted (Actual)
June 23, 2026
Study Record Updates
Last Update Posted (Actual)
June 23, 2026
Last Update Submitted That Met QC Criteria
June 18, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KFSIRB200-1082
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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