Nasal Packing After Turbinoplasty
18. juni 2026 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- 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
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
135
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Kafrelsheikh, Egypten
- Kafrelsheikh University Hospitals
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Standard bilateral Merocel® nasal tampons
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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.
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Aktiv komparator: A Merocel® tampon enclosed within the finger portion of a sterile powder-free latex surgical glove
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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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Aktiv komparator: Merocel® tampons were coated with a thin uniform layer of topical broad-spectrum antibiotic ointment
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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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Aktiv komparator: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pain intensity
Tidsramme: 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
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Nasal fullness/pressure sensation
Tidsramme: We assesed it during first 48 hours postoperative.
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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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. januar 2026
Primær færdiggørelse (Faktiske)
6. maj 2026
Studieafslutning (Faktiske)
3. juni 2026
Datoer for studieregistrering
Først indsendt
14. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
23. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
18. juni 2026
Sidst verificeret
1. januar 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KFSIRB200-1082
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