Clinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery (NCT07560254) | Clinical Trial Compass
CompletedNot Applicable
Clinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery
Malaysia20 participantsStarted 2024-09-11
Plain-language summary
This clinical trial evaluated two absorbable nasal packing materials - VELNEZ and NASOPORE - in adult patients (18-70 years) who underwent nasal surgery, including septoplasty, FESS, or turbinoplasty.
The study addressed two core questions: whether VELNEZ offered superior haemorrhage control and faster biodegradation, and whether it reduced postoperative pain, fibrosis, adhesion, and discomfort compared to NASOPORE.
Participants were randomised to receive either packing material following surgery. They were monitored on the day of surgery for haemostasis and device performance, then followed up with clinical and endoscopic assessments - including pain scoring and adverse event tracking - through Day 90.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* Participants eligible for the use of a nasal pack (either VELNEZ or Nasopore) in routine clinical practice after a planned nasal surgery.
* Male and female in the age group of 18 to 70 years. (Both Included)
* Participants or their LAR who can provide informed consent form in writing.
* Participants who allow their study data to be collected at pre-defined follow-up period.
Exclusion Criteria:
Participants who are unable to be treated with VELNEZ, or Nasopore nasal pack in routine clinical practice after a planned surgery.
* Participant's/ legal guardian (LAR) who cannot provide informed Consent written.
* Participant unwilling or unable to comply with the postoperative visits necessary for data collection.
* Participant with an active infection at the surgery site.
* Participant with a history of asthma.
* Pregnant or lactating Females
* Participant who are on aspirin or anti-platelet drugs therapy.
* Participant positive for HIV, HCV, VDRL, HBs Ag.
* Participant who is allergic (Hypersensitive) to any of the ingredients of the nasal packs.
* Participant with bleeding disorders.
* Any medical condition that, in the opinion of the investigator, would make the subject unsuitable for inclusion (e.g., a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).