Evaluation of fully biodegradable nasal packings in functional endoscopic sinus surgery a multi-centre study

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1 Evaluation of fully biodegradable nasal packings in functional endoscopic sinus a multi-centre study Ocena całkowicie biodegradowalnych opatrunków donosowych w czynnościowych endoskopowych operacjach zatok przynosowych badanie wieloośrodkowe Dariusz Jurkiewicz 1, Henryk Kaźmierczak 2, Marek Rogowski 3, Paweł K. Burduk 2, Barbara Gałusza 1, Wojciech Kaźmierczak 2, Bartosz Piszczatowski 3, Małgorzata Różańska 3, Rafał Sienicki 1, Kornel Szczygielski 1, Małgorzata Wierzchowska 2, Joanna Kuśmierczyk 4 1 Department of Otolaryngology and Laryngological Oncology with Clinical Department of Craniomaxillofacial Surgery, Central Clinical Hospital of the Ministry of National Defense of the Military Institute of Medicine in Warsaw 2 Department of Otolaryngology, University Clinical Hospital in Białystok 3 Department of Otolaryngology and Laryngological Oncology, Antoni Jurasz University Hospital in Bydgoszcz 4 Company: Medicus Aparatura i Instrumenty Medyczne Sp. z o. o. sp. k. Article history: Received: Accepted: Published: ABSTRACT: KEYWORDS: STRESZCZENIE: The aim: This work was to compare an innovative solution, i.e. a fully biodegradable nasal packing Nasopore, with a traditional one, in the aftercare of patients subjected to functional endoscopic sinus. Material and method: Prospective, blinded study with sequential enrollment conducted at three study centres. One of the investigators evaluated during the level of bleeding in each of the nasal cavities and at the end of he applied the test packing, the biodegradable dressing Nasopore, to one randomly chosen nasal cavity, and a control packing to the other one. The other investigator removed during aftercare the and conducted the follow-up. During the control visits (24-48 hours, 10 and 30 days post-op.) the subjects evaluated their headache, pain in the nose, pressure in the forehead as well as their nasal obstruction. Results: A total of 39 women and 44 men at the age of 47 years on average (min. 19, max. 82) were qualified for the study. The largest differences between different types of nasal dressings were observed with regard to reduction of nasal obstruction in the first 10 days after (P<0.005). In relation to the pain in the area of the head and nose as well the pressure in the forehead on every visit, better outcomes were observed for the test dressing. Statistical difference (P<0.05) was observed on the first follow-up visit for the headache and pressure in the forehead as well as on the first and second visit for the pain in the nose. Conclusion: The fully biodegradable nasal dressing Nasopore may constitute significant improvement and facilitation of aftercare in functional endoscopic sinus while increasing the patients satisfaction and lowering the postoperative discomfort. endoscopic sinus, after care, nasal bleeding, nasal packing, biodegradable materials Cel badania: Porównanie nowatorskiego rozwiązania w postaci całkowicie biodegradowalnych opatrunków donosowych Nasopore z tradycyjnymi opatrunkami niewchłanialnymi w funkcjonalnych endoskopowych operacjach zatok przynosowych. DOI: /

2 Materiał i metody: Badanie prospektywne zaślepione z sekwencyjną rekrutacją w czasie badania prowadzone w trzech ośrodkach badawczych. Jeden z badających w trakcie operacji oceniał stopień krwawienia w każdym z otworów nosowych oraz pod koniec operacji w losowo wybranej jamie nosa umieszczał jeden z badanych opatrunków biodegradowalny opatrunek testowy Nasopore, a w drugiej opatrunek kontrolny. Drugi z badaczy w okresie po zabiegu usuwał opatrunek kontrolny i prowadził opiekę pooperacyjną, w tym endoskopową ocenę jam nosa. Po operacji chory w trakcie wizyt kontrolnych (24-48 godz. po zabiegu, 10 i 30 dni po zabiegu) oceniał swoje dolegliwości (ból głowy, nosa, ucisk okolicy czołowej i drożność nosa) za pomocą 10-punktowej skali analogowej. Wyniki: Do badania zakwalifikowano 39 kobiet i 44 mężczyzn w wieku średnio 47 lat (min. 19, maks. 82). Największe różnice między badanymi rodzajami opatrunków obserwowano w odniesieniu do poprawy drożności nosa na korzyść opatrunku testowego w czasie pierwszych 10 dni od operacji (p<0,005). W ocenie bólu nosa i głowy oraz ucisku czoła na każdej z wizyt obserwowano lepsze wyniki dla opatrunku testowego. Różnice w odczuwanych dolegliwościach pod postacią bólu głowy i ucisku czoła w trakcie pierwszej wizyty pooperacyjnej oraz bólu nosa w trakcie pierwszej i drugiej wizyty pooperacyjnej były istotne statystycznie (p<0,05). Wnioski: Potwierdzono skuteczność i zdolność do samoistnej eliminacji opatrunków biodegradowalnych. W okresie do 10 dni po operacji obserwowano znaczną przewagę w zakresie poprawy drożności nosa, bólu nosa i głowy, a także ucisku w okolicy czoła w przypadku zastosowania opatrunków biodegradowalnych w porównaniu z opatrunkami tradycyjnymi. Opatrunki Nasopore mogą zatem stanowić usprawnienie opieki pooperacyjnej w zakresie operacji endoskopowej zatok przynosowych i stać się dużym udogodnieniem. SŁOWA KLUCZOWE: endoskopowe operacje zatok przynosowych, opieka pooperacyjna, krwawienie z nosa, opatrunek nosowy, materiały biodegradowale INTRODUCTION Nasal packings are widely used in nasal and sinus in order to prevent bleeding. As biodegradable packings facilitate wound healing, they are more commonly used in endoscopic sinus to improve local haemostasis, reduce the risk of synechia formation and prevent middle turbinate lateralisation. Concurrently, in the majority of surgeries, traditional nasal packings are used that need to be removed within a few days after. Relative superiority of each type of dressing and its influence on long-term post-operative results are still important areas of studies. The aim of the present study was to compare the novelty of fully biodegradable nasal dressing Nasopore with the currently used traditional packings, in functional endoscopic sinus. MATERIALS AND METHODS Biodegradable Nasopore test dressing manufactured by Polyganics company is made of synthetic, biologically inert polyurethane foam. This dressing, when exposed to regular moisturising, slowly fragments and disappears from the nasal cavity within 7-14 days after. A prospective, blinded study with sequential enrollment of subjects was carried out in three study centres: at the Department of Otolaryngology of Central Clinical Hospital of the Ministry of National Defense, Military Institute of Medicine in Warsaw, at the Department of Otolaryngology of University Clinical Hospital in Białystok and at the Department of Otolaryngology and Laryngological Oncology of Antoni Jurasz University Hospital in Bydgoszcz. Adult patients qualified for bilateral functional endoscopic sinus (FESS) were enrolled in the study. Study participants agreed to take part in the research project and their stage of the disease according to the Lund-MacKay staging system, general condition and additional disease burden were evaluated. During the operation one of the investigators (operator) assessed the level of bleeding in the operative field in each nasal cavity separately. Then, the test packing - biodegradable Nasopore dressing - was applied into one of randomly chosen nasal passages whereas the other one was packed with the a routine gauze nasal packing - in a latex glove finger, which was removed within 10 days after. The other investigator conducted the aftercare. Neither the patient and nor the physician performing the post-operative evaluation knew which of the nasal cavities is packed with the test packing. After hospitalisation the patients were discharged from hospital with indications to regularly administer physiological saline to the nose. In the post-operative period (24-48 h, 10 and 30 days after ), the second investigator evaluated the level of bleeding, and other complications such as the presence of synechia, inflammations and clots in the endoscopy of nasal cavities. In analogical time intervals, the patients filled out the question- 12

3 naires assessing the level of headache, pain in the nose, pressure in the forehead, and nose obstruction on the VAS (Visual Analogue Scale) scale from 0 to 10 (Table 1). Table 1. Evaluation scheme. Headache Medical interview. Qualification. Signing informed consent to take part in the study. Investigator questionnaire Patient questionnaire Visit 0 Before the X Surgery Visit h after Visit 2 10 days after Visit 3 30 days after X X X X X X X RESULTS In total, 39 women and 44 men at the average age of 47 years (min. 19, max. 82) were followed up. Two patients discontinued the participation in the study. One of them could not continue the participation due the decision to undergo surgical intervention of one side only, and in the case of the other patient there occurred bleeding which was impossible to stop using the test dressing on either of the sides, so the gauze packing was Figure 2. Headache according to self-assessment VAS scale on the side where test dressing was applied and on the side with. Pain in the nose Nasal obstruction Figure 1. Nasal obstruction based on the self-assessment VAS scale on the side with test dressing applied and on the side where was applied. Figure 3. Pain in the nose according to self-assessment VAS scale on the side where test dressing was applied and on the side with. used on both sides instead. In case of 71 patients it was the first operation, and for the rest of them a second-look operation. In the pre-operative interview, 7 patients reported high blood pressure and asthma, and 4 of them allergy. According to the pre-operative classification based on the Lund-MacKay staging system, 27 patients scored <11 whereas the score of the rest of the patients (54) was >=12. 13

4 Pressure in the forehead When evaluating the pressure in the forehead, the patients also reported less pressure in case of the test dressing compared to the (Figure 4). Statistically significant difference (p=0.006) was observed during the first h after. Figure 4. Pressure in the forehead according to self-assessment VAS scale on the side where test dressing was applied and on the side with. The surgeries were performed from May to December The average duration of was 68 minutes (min. 40 minutes, max. 120 minutes). In 13 patients, heavy intraoperative bleeding occurred, but only in case of one patient, application of an additional traditional packing on the side with priorly applied test dressing was necessary. Within the first 48 hours after, excessive nosebleed connected with removal was observed in 3 patients. The largest difference between different types of studied nasal dressings was observed with regard to improvement of post- -operative nasal passability evaluated by patients according to the self-assessment VAS scale for each nasal passage separately. Patients reported markedly better nasal passability on the side where the test dressing was applied (P<0.005) during the two first post-operative visits (up to 10 days after ). With regard to pain in the nose and headache, better results were observed for the test dressing (Figure 2 and 3) on each visit. The differences in headache evaluation during visit 1 (24-48h after ) and the differences in pain in the nose evaluation during visit 1 (24-48h after ) and visit 2 (10 days after ) were statistically significant (P<0.05). The largest differences were observed on the first visit (up to 48h after ). In the course of evaluation within 30 days after, the results flatten out to 0 value for both types of dressings. During the follow-up, on the tenth day after in three patients, it was necessary to suck off the remainings of the test dressing. Moreover, in two patients, the presence of blood clots was observed: in one of the patients - on the side where the test dressing was applied, and in the other patient - on the side with the. The final evaluation revealed the presence of postoperative synechia: in two patients on the side packed with the and in five patients on the side where the test dressing was applied. The presence of inflammations was also observed in five patients: in three of them bilaterally, in one patient - on the side packed with the test dressing and in one patient on the side with the. Middle turbinate lateralisation occurred in one patient. In their comments to questionnaires, patients indicated that on the side where the test dressing was applied it was easier to swallow saliva, eat food, they felt better ventilation and less compression there and it seemed as if the nasal cavity was empty. DISCUSSION Chronic sinusitis is a common condition affecting from 5% to 15% of the population in Europe and in the USA. Since 1980s functional endoscopic sinus (FESS) has been slowly replacing antrostomy and Caldwell-Luc procedures in cases non-responding to conservative treatment (1). In 2013 more than FESS surgeries were performed in Poland and this number still increases from year to year (2). Restoring passability of the nasal passage with mucous membrane healing and proper surgical procedure performance are necessary to achieve good results after. Taking into consideration the fragile structure of the turbinate and granulation during the process of wound healing, nasal packings and the aftercare seem to play a key role in preventing recurrences of the disease (3). Nowadays, nasal dressings are commonly used in nose and sinus surgeries (4). A dressing can be used in combination with antibiotics or steroids (5). Currently, two types of dressings are available: non-biodegradable nasal packings which have to be removed from the nasal cavity within h after, and biodegradable packings which are fragmentable due to regular moisturising of the nasal cavity. 14

5 With traditional packings being used in both nostrils, the patients reported difficulties in breathing. There is also a possibility of additional complications, such as Eustachian tube compression, leading to aeration disorders in the tympanic cavity (6), or toxic shock syndrome (7). Moreover, packing removal is painful, causes patient s discomfort and the risk of bleeding. Lately, the popularity of biodegradable nasal packings has been rising compared to nasal packings that need to be removed. As fragmentable packings facilitate wound healing (8), they are more commonly used nowadays in endoscopic sinus surgeries to improve local haemostasis, reduce the risk of synechia formation and prevent middle turbinate lateralisation. The undoubtful advantage of completely biodegradable packings is the fact that they do not need to be removed (9) which reduces the risk of damaging the postoperative structures. Additionally, the unique packing structure enables rapid and effective fluid absorption, the packing does not increase its volume and adjusts itself to the anatomical shape of the nasal cavity. CONCLUSIONS 1. In the study, the effectiveness of Nasopore nasal dressings and their ability to self-eliminate after endoscopic sinus surgeries were confirmed. 2. It was demonstrated that these dressings have good haemostatic properties, prevent synechia formation and middle turbinate lateralisation and are very well tolerated by patients, reducing their postoperative discomfort. 3. In the period immediately after, up to 10 days afterwards, the superiority of biodegradable packings in improvement of nasal passability, pain in the nose, headache and pressure in the forehead was observed, compared to the traditional packings. Therefore, Nasopore nasal dressings can significantly improve and facilitate the aftercare in case of endoscopic sinus surgeries. References 1. Côté D.W., Wright E.D.: Triamcinolone-impregnated nasal dressing following endoscopic sinus : a randomized, double-blind, placebo-controlled study. Laryngoscope. 2010; 120(6): doi: /lary z dn. 4 listopada Verim A., Seneldir L., Naiboğlu B., Karaca Ç.T., Külekçi S., Toros S.Z., Oysu Ç.: Role of nasal packing in surgical outcome for chronic rhinosinusitis with polyposis. Laryngoscope. 2014; 124(7): doi: /lary Epub 2014 Jan Szczygielski K., Rapiejko P., Wojdas A., Jadczak M., Jurkiewicz D.: Porównanie opatrunków rozpuszczalnych zastosowanych w czynnościowych endoskopowych operacjach zatok przynosowych. Otolaryngol Pol 2007; 61(5): Côté D.W. i in.: Triamcinolone-impregnated nasal dressing following endoscopic sinus : a randomized, double-blind, placebo-controlled study. Laryngoscope 2010; 120: Thompson A.C., Crowther J.A.: (1991) Effect of nasal packing on Eustachian tube function. J. Laryngol. Otol. 105, Barbour S.D., Shlaes D.M., Guertin S.R.: (1984) Toxic-shock syndrome associated with nasal packing: analogy to tampon-associated illness. Pediatrics 73, Wormald P.J., Boustred R.N., Le T., Hawke L., Sacks R.: A prospective single-blind randomized controlled study of use of hyaluronic acid nasal packs in patients after endoscopic sinus. Am J Rhinol. 2006; 20(1): Catalano PJ, Payne S, Thong M: Clinical evaluation of a fully synthetic middle meatal stent for safety and tolerability. Otolaryngol Head Neck Surg. 2011;144(3):452-6 Word count: 1262 Tables: 1 Figures: 4 References: 9 Access the article online: DOI: / Full-text PDF: Corresponding author: Prof. dr. hab. med. Dariusz Jurkiewicz, Klinika Otolaryngologii, Wojskowy Instytut Medyczny, ul. Szaserów 128, Warszawa 44, Polska, djurkiewicz@lekarz.net Copyright 2015 Polish Society of Otorhinolaryngologists Head and Neck Surgeons. Published by Index Copernicus Sp. z o.o. All rights reserved. Competing interests: The authors declare that they have no competing interests. Cite this article as: Jurkiewicz D., Kaźmierczak H., Rogowski M., Burduk P.K., Gałusza B. et al.: Evaluation of fully biodegradable nasal packings in functional endoscopic sinus a multi-centre study. Otolaryngol Pol 2015; 69 (1):