An Analysis of the VELNEZ Nasal Pack’s Acceptability and Safety for Use During Nasal Surgery: A Prospective Study

Abstract

The primary function of nasal packs is to modulate the bleeding, prevent adhesions and obstruction, with least discomfort to the subjects without risking secondary infection. However, both packing and removal of the pack is an unpleasant experience, with the latter being extremely painful. Therefore the need of the hour is a dressing which prioritizes subject comfort without compromising other desired nasal pack properties. Twenty subjects were enrolled in this interventional, open label study. The subjects had 10 hospital visits, starting from baseline (Visit 1) to postoperative day 28 (Visit 10), at regular intervals. The proportion of the population with postoperative pain alleviation and bleeding control failure (within 10 min) were the main objectives. Within 10 min of VELNEZ administration, all 20 participants got their bleeding under control. With VELNEZ, the painful nasal pack removal method was totally avoided because it was biodegradable. No moderate/severe pain, infection and adhesions were reported in any of the subjects, but few subjects reported moderate obstruction until Visit 3 (Discharge Day). In the present study, for participants undergoing nasal surgery, VELNEZ proved to be a secure and reliable nasal pack.

Trial Registration: CTRI/2021/09/036437, prospectively registered.

Introduction

Nasal surgeries in the practice of otolaryngology, use nasal packs for post-operative care routinely. The primary purpose of these packs is to ensure intra-operative and post-operative hemorrhage control [1]. Bleeding is a concern even during the recovery period and on pack removal, as the latter might disrupt the mucosal membrane [2, 3]. Therefore, the ideal pack should be successful in achieving hemostasis during these phases as well. Apart from achieving hemostasis, an ideal pack should reduce adhesions and nasal obstructions, without causing any infection at the surgery site [4].

However, despite these proficiencies, nasal packs commonly used are known to trigger breathing difficulty, headache, synechiae formation, pain, dryness of mouth, watering of eyes etc. [5]. The main concern with the use of these packs is the discomfort and pain the subject undergoes during nasal packing and removal, with the removal being the most unpleasant experience. Keeping in view these shortcomings, some surgeons avoid packing the surgery site, post-surgery [6, 7]. However, majority of studies have advocated the use of nasal packs in surgeries, as the advantages outweigh the disadvantages [8].

Broadly the available nasal packs are either classified as absorbable or non-absorbable. Primarily, the widely used conventional nasal packs are non-absorbable type [2]. Although these removable packs are suitable in achieving hemostasis post-surgery, they do not answer the problems of pain and hemorrhage during pack removal [4, 9]. Therefore, to ameliorate the nasal pack- induced pain, hemorrhage and discomfort in subjects, the use of absorbable nasal packs can be a better choice, as the painful removal step is redundant. The goal of this research was to evaluate the safety and acceptability of using the biodegradable composite VELNEZ as a packing material in patients having scheduled nasal surgery. Total exposure of investigational medical device VELNEZ is 2 to 7 days only.

Materials and Methods

This study took place following registration at Clinical Trials Registry and institutional ethical committee approval. This was an open label, interventional study. Before beginning any study-related procedures, all individuals gave their informed consent.

Twenty screened patients scheduled for various nasal surgeries were screened and enrolled in the study after qualifying the inclusion criteria (Fig. 1). The participants were followed for 4 weeks over 10 visits in total (Fig. 2). The packing used after surgery was VELNEZ nasal pack (2*4 cm size),

Fig. 1.

CONSORT diagram for the study

Fig. 2.

Trial Design

The proportion of the population with postoperative pain alleviation and bleeding control failure (within 10 min) were the main objectives. The Secondary Endpoint(s) of the study were subjects having pain, obstruction, infection at the site of VELNEZ application. The Pain VAS Scale was used to gauge pain relief from the day of operation to the follow-up Visit 10; pain is defined on VAS scale of 1 (No Pain)-10 (Worst Pain). Nasal obstruction was evaluated through Scale (0–10) (where 0 refers no obstruction and 10 refers complete obstruction), from surgery day to follow up visit 9. Presence of adhesions were also checked in these 20 subjects. Adhesion was categorized on a 0–3 scale; 0 = No Adhesion 1 = Easy to release, 2 = Difficult to release, 3 = Need surgical intervention.

Results

Total of 20 participants who were enrolled for the study, all completed the study. The demographic parameters are as summarized in Table 1. All 20 (100%) subjects had hemorrhage control within 10 min of application of VELNEZ. As shown in Fig. 3 and 85% of the participants achieved hemostasis within 2 min.

Table 1.

Summary of demographic characteristics

Age (years)
Mean ± SD	32.10 ± 10.89
Median	32.00
Range	(18.00–54.00)
Height (cm)
Mean ± SD	157.37 ± 4.39
Median	158.00
Range	(147.32–163.00)
Weight (Kg)
Mean ± SD	62.25 ± 6.91
Median	62.50
Range	(45.00–72.00)
BMI (Kg/m2)
Mean ± SD	25.06 ± 1.75
Median	25.20
Range	(19.48–27.34)
Sex, n (%)
Female	10 (50.0)
Male	10 (50.0)
Smoker, n (%)
No	19 (95.0)
Yes	1 (5.0)

Fig. 3.

Time for hemostasis in study subjects

None of the subject reported any significant pain on any of the study visits (Fig. 4). Four subjects (20%) reported moderate obstruction on Visit 1, 5(25%) on visit 2, 1(5%) subject on visit 3. No nasal blockage was experienced by any of the participants, beyond third visit. None of the subjects’ showed features of infection in nasal cavity during any of the follow up visits. Additionally, no adhesions were observed in subjects after surgery and VELNEZ application, except for one patient in whom easy to release adhesion was observed on Visit 1.

Fig. 4.

Participants showing moderate pain, evaluated on a VAS scale of 0–10; 0-no pain, 5-moderate pain, 10-severe pain

The cumulative adverse events (AE) and serious adverse events (SAE) that occurred throughout the research period was calculated by taking into account both the number of individual occurrences and the number of individuals who experienced them. MedDRA Version 24.1 was used for AE coding. There were 4 AEs reported in the study, with 1 reporting nausea, 1 reporting headache and 2 reporting pyrexia. However, these AEs were not related to the study product and resolved conservatively.

Discussion

Intranasal packing post nasal surgeries is a well-established practice in Otorhinolaryngology. These packing materials function by creating a healing conducive microenvironment, causing minimal damage and/or infection at the site [10]. To achieve these, surgeons depending on their discretion, use either removable nasal packs or absorbable nasal packs or avoid using any packing material at all [11]. The conventionally used non-absorbable packs include Vaseline or antibiotic-soaked gauzes, Merocel, balloon tamponade, polyvinyl alcohol etc. [2]. These non-resorbable packing materials successfully control bleeding by pressure-induced compression of blood vessels. Nonetheless, removable packs exert continuous pressure on the mucosal membrane, eventually damaging it. To avoid compression-induced mucosal trauma, surgeons either cover the nasal pack with latex finger from surgical gloves or use special coating to prevent adhesions or use saline inflated balloon to control bleeding and cause minimal damage [10]. Merocel, a compressed dehydrated sponge, is one of the widely used non resorbable packing material. However, pain and discomfort on removal, mucosal damage and edema are the common problems associated with this product [12].

To overcome the shortcomings of the removable packs, a wide range of absorbable packing material are currently available like Surgiflo, carboxymethyl cellulose, Merogel, Floseal to name a few. The resorbable packs achieve hemostasis by using either coagulating factors or stimulators [2]. Despite several studies that have compared the various types of absorbable nasal packs amongst themselves and also with the widely used removable packs [2, 8], no consensus has been reached as to which packing material is superior. Even so, as far as the subject comfort and quality of life is concerned the absorbable packs are a better choice over the removable ones as the problems associated with pack removal stands void [13].

Both intraoperative and post operative bleeding control, is the primary challenge a surgeon has during nasal surgeries. Therefore, the nasal pack being used should be proficient in achieving hemostasis, during and after surgery. The first 15–20 min are crucial during surgery and the primary pack should be successful in achieving hemostasis during this period, else other interventional strategies need to be adopted [8]. Surgiflo, a sterile absorbable porcine gelatin, reported intra-operative hemostasis in 96.7% subjects, within 10 min of application [14]. In this study, hemostasis on VELNEZ application was achieved within 2–3 min of surgery in 100% patients. This proficient hemostatic efficacy of VELNEZ could be attributed to PVA (Polyvinyl alcohol). PVA one of the components of VELNEZ is studied to be efficient in controlling bleeding. Wang et al., in their comparative meta-analysis study, stated that absorbable packs exhibited better post-operative hemostatic efficacy when compared to the removable packs [13]. Therefore, these packs are more appropriate for patients with bleeding anomalies [15].

Other common complications with the use of nasal packs are adhesions and synechiae formations. These are formed primarily in the proliferation and the remodeling phase of the wound healing process [16]. Studies have highlighted that both absorbable as well as non absorbable packs are equally vulnerable to synechiae formation [13]. In their investigation, Baumann et al. found no difference between the absorbable pack Floseal and the non-absorbable pack Merocel in the rate of synechiae production [17]. The unfavorable part of these absorbable packs, which might trigger synechiae formation, is its prolonged presence in the nasal cavity, subject to the type of material and degradation time. Packing material like chitosan and hyaluronic acid are known to be resistant to synechiae formation [16]. The investigational product in this study consists of Chitosan which is known to prevent adhesions and infection at the surgery site. In the current study, the non-removable nature of this pack along with one of the pack materials i.e. chitosan facilitated the surgery site to be free from any infection or adhesion. No adverse or serious adverse events were reported, attributable to this pack in this study.

In this study the nasal pack disintegrated within a short period of time, hence obviating the need for removal, thus painful experience of removal was not there for patients. Park et al. in their study highlighted the following properties of an ideal nasal pack as; biodegradable or absorbable in nature, biocompatible, no pain on removal, anionic nature, cost effective, should control bleeding and prevent blood clots, keep the site free from infection, should not trigger any immune response or allergic reaction or secondary injury [18]. VELNEZ nasal pack displayed these properties.

Conclusion

In this prospective study, VELNEZ displayed excellent hemostatic potential with no adhesions or infection at the surgery site. Post-operative pain was manageable without analgesics and no product related adverse or serious adverse events were reported. In brief, VELNEZ appears to be safe and effective packing material for patients scheduled for nasal surgery.

Funding

Funding was provided by datt mediproducts.

Declarations

Conflict of interest

There is no conflict of interest for Dr Akhil Pratap Singh, Dr Saloni Singh, Dr Ridhima Malik and Dr Ritu Gupta. Dr Siddharth Pandey is the Head of Research and Development and Vice-President at Datt mediproducts, the manufacturer of VELNEZ nasal pack. VELNEZ is the product under study in this research.

Human and animal rights

Involving Human participants

Informed consent

In obtaining and documenting informed consent, the Investigator complied with applicable regulatory requirements, and adhered to ICMR Guidelines Ethical Guidelines for Biomedical Research on Human ACCEPTED MANUSCRIPT Accepted manuscript 3 Participants, International Conference on Harmonisation Guideline-Good Clinical Practice (ICH-GCP) and the Declaration of Helsinki.