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 range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.