NCT07663929

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
Last Updated

June 23, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

June 14, 2026

Last Update Submit

June 18, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    1.Pain intensity Assessed using the Visual Analogue Scale (VAS) (0 = no pain, 10 = worst imaginable pain)

    We assesed pain during first 48 hours postoperative.

  • Bleeding after packing removal Assessed using a 4-point grading scale

    Grade 0 = no bleeding Grade 1 = oozing Grade 2 = continuous bleeding Grade 3 = bleeding requiring intervention or control in the operating room

    We assesed bleeding immediately after nasal packing removal

Secondary Outcomes (1)

  • Nasal fullness/pressure sensation

    We assesed it during first 48 hours postoperative.

Study Arms (4)

Standard bilateral Merocel® nasal tampons

ACTIVE COMPARATOR
Procedure: Standard bilateral Merocel® nasal tampons packing after Microdebrider-assisted inferior turbinoplasty

A Merocel® tampon enclosed within the finger portion of a sterile powder-free latex surgical glove

ACTIVE COMPARATOR
Procedure: A Merocel® tampon was enclosed within the finger portion of a sterile powder-free latex surgical glove after Microdebrider-assisted inferior turbinoplasty

Merocel® tampons were coated with a thin uniform layer of topical broad-spectrum antibiotic ointment

ACTIVE COMPARATOR
Procedure: Merocel® tampons were coated with a thin uniform layer of topical broad-spectrum antibiotic ointment after microdebrider-assisted inferior turbinoplasty

sterile ribbon gauze impregnated with white petroleum jelly (paraffin)

ACTIVE COMPARATOR
Procedure: terile ribbon gauze impregnated with white petroleum jelly (paraffin) after microdebrider-assisted inferior turbinoplasty

Interventions

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.

Standard bilateral Merocel® nasal tampons

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.

Merocel® tampons were coated with a thin uniform layer of topical broad-spectrum antibiotic ointment

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.

sterile ribbon gauze impregnated with white petroleum jelly (paraffin)

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.

A Merocel® tampon enclosed within the finger portion of a sterile powder-free latex surgical glove

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh University Hospitals

Kafrelsheikh, Egypt

Location

MeSH Terms

Interventions

PetrolatumParaffin

Intervention Hierarchy (Ancestors)

HydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 23, 2026

Study Start

January 1, 2026

Primary Completion

May 6, 2026

Study Completion

June 3, 2026

Last Updated

June 23, 2026

Record last verified: 2026-01

Locations