An observational study to evaluate the safety and tolerability of velnez nasal pack after nasal surgery as compare to other marketed nasal packs
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2017/07/008958
- Lead Sponsor
- Datt Mediproducts Pvt Ltd
- Brief Summary
Chronic sinusitis is a common condition in which the cavities around nasal passages (sinuses) become inflamed and swollen for at least 12 weeks, despite treatment attempts.An estimated 134 million Indians suffer from chronic sinusitis.Functional endoscopic sinus surgery (FESS) has today become the norm in such cases providing successful results world-over. Newer nasal packs which have recently emerged in the Indian scenario are found to be more user-friendly, equally effective for hemostasis and less traumatic to the operated nasal mucosa.
Datt Mediproducts Pvt Ltd (DMPL) is entering in this segment with VELNEZ It is a biodegradable composite that fragments within few days on application intended as nasal packing. It is acts as a space occupying dressing, prevents adhesion by separating the compromised mucosal surfaces and also helps in healing and achieving haemostasis. This device (VELNEZ) is approved for marketing/free production by State Government of Haryana, India.
The rationale for this study is to substantiate the safety and tolerability of VELNEZ in patients undergoing for nasal surgery and also collect comparative data on safety and patient comfort level on real time use with respect to other marketed available biodegradable & non- biodegradable as nasal packs.
**Statistical Analysis Plan:**
We are planning a prospective, controlled study, as per previous study
(i) For testing efficacy of Velnez vs biodegradable and non – biodegradable nasal packs, the Hypothesis to be tested will be
**H0: µ1 = µ2**
Which states, “There is no significant difference of Velnez over biodegradable and non – biodegradable nasal packs based on comparative analysis of the VAS scoresâ€.
(ii) The alternative Hypothesis to be tested will be
**H1: µ1 ≤ µ2**
Which states that “Average VAS score of the subjects receiving VELNEZ is less than the VAS score of biodegradable and non – biodegradable nasal packs recipientâ€.
In this study, the Type I error probability associated with this test of this null hypothesis is 0.05 and sample size was considered 10 for each nasal packs as per previous study mentioned above, thus we need to study 30 experimentally controlled subjects to be able to reject the null hypothesis. These adults were diagnose with moderate to severe bilaterally comparable chronic rhinosinusitis, who undergoing for nasal surgery under general anesthesia and received size-matched nasal packs Velnez or biodegradable and non – biodegradable nasal pack. The assessment of clinical efficacy of all nasal packs with regards to ease of packing, hemostasis, pressure effects, infections and adhesions will done with a diagnostic Nasal Endoscopy/CT at first preoperative day, 14 days and 28th days after the surgery. Patient comfort levels for both packs were recorded with a standard symptom questionnaire marked on a visual analogue scale of ten and the results will statistically compared between the groups.
The Study data will be collected in paper format of CRF and will be analysed by Open R software or higher version. For comparative evaluation of efficacy of VELNEZ/ biodegradable or non – biodegradable nasal packs is based on prevention of adhesion and hemorrhage control after the nasal surgery. The number of subjects treated with nasal pack and having symptom of no bleeding status and no pain will be considered for statistical analysis and compare with other subjects treated with biodegradable or non – biodegradable nasal packs. The events of fall in Pain/ pressure effect due to packing, nasal discharge, Nasal obstruction will be considered as secondary end-point and analysed as per likert scale. The safety analysis will be done for status at after surgery, at discharge, 2nd day, 4th day, 6th day, 8th day,10th day, 2nd week, 3rd week and fourth week for safety issues after Surgery.
The events of infection, Bleeding events, and allergic reactions will be reported as safety issues and will be considered with time to event analysis during follow-ups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 30
- 1.Age in between 18-60 years.
- 2.The subject has a planned nasal surgery (either for septoplasty with or without FESS or turbinoplasty).
- 3.Subjects who can provide informed consent form in writing and medically in a position to undergo consent and screening processes.
- 4.The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations.
- 1.Subjects with medical emergency, where treatment is more essential than the informed consent process and he or his representative deny to participate in study.
- 2.Subjects who cannot provide informed consent such as unconscious subjects.
- 3.Subjects unwilling or unable to comply with the postoperative visits necessary for data collection.
- 4.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.
- 5.Subject has an active infection at the planned surgery site.
- 6.Subjects who have a history of previous septoplasty, allergy and/or asthma 7.Postoperative recurrent rhino sinusitis, patients with bleeding diathesis, 8.Subject on aspirin or anti-platelet drugs therapy.
- 9.hypertensive patients 10.Subjects who have a history of allergic (Hypersensitive) reactions with any of the ingredients of the device i.e Chitosan, Gelatin etc.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of population, failure to cease haemorrhage after VELNEZ packing in nasal cavity 20 minutes
- Secondary Outcome Measures
Name Time Method Difference in subject comfort level in compare of other VELNEZ/Biodegradable or Non–Biodegradable nasal packs after nasal surgery in enrolled subjects. after surgery, at discharge, 2nd day, 4th day, 6th day, 8th day, 10th day, 2nd week, 3rd week and 4th week after Surgery
Trial Locations
- Locations (1)
Dr. Hans Centre
🇮🇳South, DELHI, India
Dr. Hans Centre🇮🇳South, DELHI, IndiaDr J M HansPrincipal investigator011-41071842jmhans1@gmail.com