A study (PMS) to check and assess the safety and tolerability of a biodegradable nasal dressing (VELNEZ) after nose surgery.

Not Applicable

Completed

Brief Summary: Functional endoscopic sinus surgery (FESS) has today become the norm in chronic rhinosinusitis, which provides successful results world-over. Nasal packs which have recently emerged in the Indian scenarios are found to be more user-friendly, equally effective for haemostasis and less traumatic to the operated nasal mucosa. VELNEZ nasal pack manufactured and marketed by Datt Mediproducts Private Limited is a biodegradable composite that fragments within few days on the application intended as nasal dressing. The pain associated with the traditional nasal pack removal is completely eliminated with VELNEZ since removal procedures is not necessary on the application of VELNEZ. Also reduces fibrosis at the same time promotes healing and clotting. The rationale of this study is to assess the safety and tolerability of VELNEZ as a nasal pack in subjects undergoing for planned nasal surgery.

Recruitment & Eligibility

Inclusion Criteria

Subject eligible to use VELNEZ as a nasal pack in routine clinical practice after planned surgery (either for septoplasty or turbinoplasty).
Male and female of age group between 18 to 60 years.
Subjects who can provide informed consent form in writing to provide data for the study.
Subjects who allow their data to be collected for the study at predefined follow-up periods.

Exclusion Criteria

Subject who unable to treat with the VELNEZ as a nasal packing in routine clinical practice after planned surgery.
Subject who cannot provide written informed consent for data collection.
Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
Subject with an active infection at the planned surgery site.
Subject with a history of asthma.
Subject who are on aspirin or anti-platelet drugs therapy.
Hypertensive subjects.
Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e Chitosan, Gelatin and Psyllium husk etc.
Subject 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).
Subjects with severe rhinosinusitis involving all the paranasal sinuses associated with sinonasal polyposis, allergic fungal rhinosinusitis, gross septal deviation or spurs hitching on the ostiomeatal complex (OMC) region huge concha bullosa or allergic turbinate hypertrophy in contact with septum.
Subjects with a history of prospective recurrent rhinosinusitis and subjects with bleeding diathesis.

Primary Outcome Measures

Name	Time	Method
Study participants who achieve complete hemostasis with 20 minutes without any	20 minutes of VELNEZ application.
associated adverse events.	20 minutes of VELNEZ application.

Secondary Outcome Measures

Name	Time	Method
Study participants having moderate pain.	Study participants having moderate obstructionStudy participants having infection at the site of VELNEZ application.

Locations (1): Department of ENT, S.N Medical college
🇮🇳
Agra, UTTAR PRADESH, India
Department of ENT, S.N Medical college
🇮🇳Agra, UTTAR PRADESH, India
Dr Akhil Partap Singh
Principal investigator
7895464858
researchsnmc111@gmail.com