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 scores”.

(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 recipient”.

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 28^th 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.