Comparison of Three Different Polyvinyl Alcohol Packs Following Functional Endoscopic Nasal Surgery

Transcription

1 The Laryngoscope VC 2014 The American Laryngological, Rhinological and Otological Society, Inc. Comparison of Three Different Polyvinyl Alcohol Packs Following Functional Endoscopic Nasal Surgery Andrea Melis, MD; Apostolos Karligkiotis, MD; Corrado Bozzo, MD; Nikolaos Machouchas, MD; Luca Volpi, MD; Paolo Castiglia, MD; Paolo Castelnuovo, MD; Francesco Meloni, MD Objectives/Hypothesis: To compare the extent of bleeding and patient discomfort during packing removal of three different polyvinyl alcohol (PVA) packs: 1) a standard PVA sponge (s-pva) (Mondocel Standard 10 cm; Mondomed NV, Hamont- Achel, Belgium); 2) a PVA sponge with oxidized cellulose (oc-pva) (Merocel Hemox 10 cm; Medtronic Xomed Surgical Products, Jacksonville, FL); and 3) a PVA sponge with polyethylene film (pf-pva) (Merocel cm; Medtronic Xomed Surgical Products, Jacksonville, FL), after functional endoscopic sinus surgery and inferior turbinoplasty. Study Design: A prospective, randomized, blinded, controlled trial. Methods: Ninety consecutive patients were enrolled and randomized to receive in each side one pack in the middle meatus and another pack of the same material in the nasal fossa. The patients were equally divided in three groups of 30 patients each. Group A received the pf-pva; group B received oc-pva; and group C received s-pva. Postoperatively, bleeding after removal of the entire nasal packing was evaluated by an observer, whereas the severity of pain was rated by patients with visual analog scales. Results: Our study evaluated three nasal packing materials, demonstrating that the pf-pva is less painful than the others but with intermediate bleeding ratio. However, the oc-pva has an intermediate pain score but minimum bleeding. The s-pva showed the worst pain and bleeding results. Conclusions: Considering that removal of the second pack (middle meatus) is more painful than the first (nasal fossa), our results suggest that a pf-pva can be placed in the middle meatus and a oc-pva in the nasal fossa in order to reduce patient s discomfort in terms of pain and bleeding. Key Words: Nasal packing, nasal bleeding, pain, endoscopic sinus surgery, Merocel Hemox, Merocel 2000, Mondocel Standard, polyvinyl alcohol. Level of Evidence: 1b. Laryngoscope, 125: , 2015 From the Division of Otorhinolaryngology, Department of Surgical, Microsurgical and Medical Sciences (A.M., A.K., C.B., N.M., L.V., F.M.), Institute of Hygiene (PAOLO CASTIGLIA), University of Sassari, Sassari, Italy; and the Division of Otorhinolaryngology, Department of Biotechnology and Life Sciences (PAOLO CASTELNUOVO), University of Insubria, Varese, Italy. Editor s Note: This Manuscript was accepted for publication December 1, The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Apostolos Karligkiotis, MD, Division of Otorhinolaryngology, Department of Surgical, Microsurgical and Medical Sciences, University of Sassari, Azienda Ospedaliero Universitaria di Sassari, Viale San Pietro 43, Sassari, Italy. alkis.karligkiotis@gmail.com DOI: /lary INTRODUCTION Currently, functional endoscopic sinus surgery (FESS) is universally considered the gold standard treatment for chronic rhinosinusitis, with and without polyps, after medical therapy failure. Whereas the surgical procedure is well known and standardized, 1 nasal packing and postoperative care are still a matter for debate. 2,3 Although some authors advocate the use of nasal packing, 4 others state that it should be withheld in the majority of patients. 5 However, packing is still routinely used after FESS in order to reduce postoperative bleeding and to help mucosal healing (in the middle meatus) by preventing synechia formation. 4,6 In the immediate postoperative period, nasal packing may cause headache and oropharyngeal dryness due to prolonged oral breathing. 7 Generally, packing removal is remembered by patients as the worst experience during hospitalization time due to the acute pain they may feel and the discomfort experienced should nasal bleeding occur. 8 Thanks to the technological progress, several materials with different features and biological characteristics have been manufactured for nasal packing. 7,9 15 Knowledge of the properties of each material is essential for selecting the best device in each case. However, due to local market factors, availability, and actual differences in the effectiveness of the materials, the use of nasal packs varies in different countries. 15 In Italy, for example, the expandable polyvinyl alcohol (PVA) nasal packs are the most popular. The aim of the present study is to compare the extent of bleeding and patient discomfort during packing removal of three different nonabsorbable PVA nasal packs: 1) a standard PVA sponge (s-pva) (Mondocel Standard 10 cm; Mondomed NV, Hamont-Achel, Belgium); 2) a PVA sponge with oxidized cellulose (oc-pva) (Merocel Hemox 10 cm; Medtronic Xomed Surgical Products, Jacksonville, FL); and 3) a PVA sponge with polyethylene film (pf-pva) (Merocel cm; Medtronic Xomed Surgical Products, Jacksonville, FL). 1067

2 Fig. 1. (A) Merocel cm. (B) Merocel Hemox 10 cm. (C) Mondocel Standard 10 cm. One pack was cut according to the size of the middle meatus and placed between the middle turbinate and the lateral nasal wall. An entire second pack of the same material was placed in the nasal fossa. [Color figure can be viewed in the online issue, which is available at MATERIALS AND METHODS A prospective, randomized, controlled and blinded study was conducted evaluating the amount of bleeding and patient discomfort during removal of three different PVA sponges. The study met the approval by the Sassari Board of Ethics. the sides to further minimize tissue trauma during placement and removal. All devices were provided in sterile packaging (Fig. 1). We analyzed these packs because they are the only ones provided by our hospital and routinely used in our division. However, these products may not be available to all markets. Study Devices A PVA pack is a polymer made from esterified hyaluronic acid. In its dry state, it is a compressed, hygroscopic, white nonwoven material. After contact with blood or water, the pack expands and becomes soft and elastic, allowing it to apply light to moderate pressure inside the nasal cavity. The smaller the pores of the pack, the less likely it is for granulation tissue to grow inside the pack; also, its surface remains smoother. Smaller pores increase the density of the packs and the maximal tensile strength. 8,15 The expandable PVA nasal packs used in this study were as follows: 1) The s-pva is a standard 100% PVA pack with a spongy porous structure. 2) The oc-pva is a PVA sponge with oxidized cellulose, which is a hemostatic agent. Cellulose refers to polysaccarides that are widely present in nature in the walls of plant cells. Oxidized regenerated cellulose (Surgicel; Johnson & Johnson Medical, Arlington, TX) was first used in the 1960s for epistaxis treatment. Nowadays, it is used for inducing hemostasis in cases of diffuse intraoperative nasal bleeding. 8,16 3) The pf-pva is a PVA sponge coated with polyethylene film on 1068 Patients and Study Design All patients underwent bilateral FESS for chronic rhinosinusitis with or without polyps. The surgery was identical on each side and followed the technique described by Stammberger and Posawetz. 1 Bilateral inferior turbinoplasty 13 for concomitant inferior turbinate hypertrofy was associated in all cases. Exclusion criteria included diabetes, coagulation disorders, immunodeficient disorders, previous sinus surgery or sinonasal trauma, and patients scheduled for concomitant septoplasty. Bronchial asthma and aspirin intolerance were not an exclusion criteria. All patients provided mandatory signed consent forms and were randomly assigned using a closed envelope system to be packed with one of the three study materials. Patients were blinded to the type of pack inserted in the nose. The same dressing was inserted in both nasal cavities of each patient. On completion of the surgical procedure, an envelope was opened, and one appropriate pack was cut according to the size of the middle meatus and placed between the middle turbinate and the lateral nasal wall to facilitate healing and avoid scaring. An entire second appropriate pack of the same material was placed

3 TABLE I. Demographic Data of Patients in the Three Groups. Gender Age (years) Male Female N Mean SD N % N % Group A Group B Group C ANOVA F ; P Pearson s v ; P ANOVA 5 analysis of variance; SD 5 standard deviation. in the nasal fossa to prevent bleeding from the inferior turbinate. 8,13 During the postoperative period, all patients received systemic antibiotics and steroids for 10 days (amoxicillin plus clavulanic acid 1 g three times daily; and prednisone, tapering the dose from mg). Paracetamol (1 g 1 3 times daily) was the only analgesic to be administered if needed, whereas nasal packing was in situ. The packs were removed on the second postoperative day (without any analgesics or tranquilizers pretreatment) by a single physician (operating in blind) who had not been the operating surgeon and who questioned the patients with the aid of a visual analog scale (VAS). Two horizontal parallel VASs measuring 10 cm, corresponding to the right and left nasal cavities, were presented to the patients immediately after removal of the nasal packs. Each patient was asked to draw a vertical line between 0 to 10 cm ( no pain [0] to unbearable [10]). The patients self-rated the severity of pain after removing the first packs (placed in the nasal fossa) and then after removing the second packs (placed in the middle meatus). Packing removal always started with the right nasal cavity. Bleeding after removal of the entire nasal packing was evaluated by the same observer, who rated the amount on a scale from no bleeding (0) to severe bleeding with need to repack (3). the packs were removed before the estimated time (48 hours after surgery). The differences between the three groups regarding pain scores on removal of the first and second pack, as well as the amount of bleeding for the three different nasal packs, are highlighted in Figure 2. During bilateral removal of the inferior nasal packing, the lowest pain score was reported for the pf-pva. The s-pva had the greatest pain score, and the oc-pva was reported to have an intermediate pain score. The difference between them was statistically significant (P ). The same statistical significance between pf-pva, oc-pva, and s-pva was also found during bilateral removal of the second nasal packing assigned to the middle meatus (P ). Comparison of the pain during removal of the first packing (placed in the nasal fossa) and the second packing (placed in the middle meatus) was performed in all three groups. In each group, pain was significantly higher during removal of the second nasal pack (P , P < , and P < for group A, B, and C, respectively). Bleeding after pack removal was treated with the application of cotonoids soaked in phenylephrine hydrochloride only. Only three patients had a significant hemorrhage requiring repacking of the nasal fossas (two patients after removal of s-pva and one after removal of pf-pva). The bleeding ratio was significantly highest for the s-pva compared to that for pf- PVA (intermediate bleeding) and oc-pva, which had the lowest ratio (P ). DISCUSSION Functional endoscopic sinus surgery is one of the most common surgical procedures in the field of otorhinolaryngology for surgical treatment of chronic rhinosinusitis. 1 Nasal packing is used to control oozing of blood in to the naso- and oropharynx, which could increase the Statistics Categorical variables were compared with Pearson s v 2 - test, and continuous variables were assessed by analysis of variance. Because the outcomes (pain and bleeding during nasal packing removal) were not normally distributed, comparison between groups was performed using the Kruskal Wallis oneway analysis of variance by ranks. A P value < 0.05 was considered statistically significant. The difference in pain between the first and the second pack removal was compared using the Wilcoxon rank-sum test. Data were analyzed using Stata, version 11.0 (StataCorp, College Station, TX). RESULTS The study sample included 90 patients (62 males, 68.9% and 28 females, 31.1%) with a mean age of years (range, years). The patients were equally divided in three groups of 30 patients each. Group A received pf-pva 8 cm; group B received oc-pva 10 cm; and group C received s-pva 10 cm. No significant differences were observed regarding gender and age distribution between the three groups (Table I). No bleeding was observed while the nasal packs were in situ, and none of Fig. 2. Differences between the three groups of nasal packs (pf- PVA, oc-pva, s-pva), regarding pain scores on removal of the first pack from the nasal fossa (Pain_1) and on removal of the second pack from the middle meatus (Pain_2), as well as the total amount of bleeding after removal of both packs, in each group of patients. oc-pva 5 polyvinyl alcohol sponge with oxidized cellulose; pf- PVA 5 polyvinyl alcohol sponge with polyethylene film; s- PVA 5 standard polyvinyl alcohol sponge; PVA 5 polyvinyl alcohol. [Color figure can be viewed in the online issue, which is available at

4 risk of aspiration during recovery from general anaesthesia, prevent bleeding during the postoperative period, facilitate healing, and prevent adhesion or the formation of fibrin-like structures in the middle meatus by keeping the middle turbinate and lateral nasal wall separated. 4,6,14 Several nondegradable materials are available for nasal packing, for example, vaseline gauze strips, various expandable PVA sponges (Merocel, Mondocel, Netcell [Network Medical Products, Ripon, United Kingdom], etc.), Rapid Rhino (ArthroCare UK Ltd., Glenfield, United Kingdom), and Algosteril (Nanterre Cedex, France). New biodegradable packing materials have also been developed, for example, NasoPore (Polyganics, Rozenburglaan, Groningen, The Netherlands), Merogel (Medtronic Xomed Surgical Products, Jacksonville, FL), FloSeal (Baxter International Inc., Deerfield, IL), and Gelfoam (Upjohn, Kalamazoo, MI). 7,9 15 Selection is based on local market factors, availability, experience, costs, and personal preferences of each surgeon. The present study of three conventional removable nasal packs is not intended to compare nondegradable and biodegradable materials but to report our experience to those surgeons who still use removable packing materials after endoscopic nasal surgery. Although typically effective, nonabsorbable packing is uncomfortable; and its removal is painful and commonly associated with bleeding, causing anxiety to the patients. 7 In order to avoid these discomforts, nasal packs should be easily removable, causing less pain and effectively preventing postoperative bleeding. We tested three different PVA sponges with some modifications that were commonly used in our division: one with oxidized cellulose (oc-pva), one laminated with polyethylene (pf-pva), and one standard PVA pack (s-pva). To the best of our knowledge, this is the first study involving oc-pva. Evaluation of the level of pain during removal and the reappearance of bleeding was conducted. The visual analogue scale was chosen due to the simplicity and accuracy in quantifying pain. 17 PVA is one of the most common packing materials. Previous studies reported that PVA has a tendency to adhere to the mucosa, causing pain and bleeding during removal. 18 Our results demonstrate that the pf-pva caused less pain during removal compared to the other two types of nasal packing. Also, the oc-pva caused less pain compared to the s-pva. These results were statistically significant (P ) and might be due to major mucosal adhesion of the simple PVA sponge (s-pva). In accordance with other studies, laminated packs are less abrasive and associated with less pain. 18 To our knowledge, there are no studies evaluating pain during removal of the packs that compare those in the nasal fossa to those in the middle meatus. Our study evidenced a higher level of pain during removal of the second pack from the middle meatus, despite the smaller size of the pack. This was observed for all three pack types used and was statistically significant (P ). However, pf-pva showed less pain compared to oc-pva and to s-pva, which was the most painfull. These results were statistically significant (P ). One 1070 possible conclusion that may be drawn is that greater mucosal adhesion in the middle meatus is due to more extensive wounding of the mucosal surfaces. Ethmoidectomy leads to mucosal injury on the lateral wall and roof of the middle meatus, whereas correction of anatomical variants of the middle turbinate such as concha bullosa or paradoxical curvature cause mucosal damage of the medial wall of the middle meatus, although to a small extent. Therefore, major mucosal injury (three walls of the middle meatus) seems to lead to major mucosal adhesion of the packs and greater pain during removal. The pf-pva with laminated sides has less adhesion to the mucosa, causing less pain than the others. In accordance with other studies, packs with a polyethylene film are less painful on removal. 19 The oc-pva containing oxidized cellulose also has less adhesion compaired to normal PVA sponges (s-pva). In the nasal fossa where the first pack was placed, only the mucosa of the inferior turbinate was injured due to its volumetric reduction, whereas no patient in the present study had concomitant septoplasty (one wall injured). This could explain the significantly higher level of pain reported by all patients during the removal of the second pack from the middle meatus. Regarding the hemostatic properties of the three different packs, the data presented show that none of the 90 patients enrolled in the study bled within the first 48 hours after surgery. These findings show that all three materials are equally effective in preventing postoperative bleeding. Bleeding caused on removal of both packs from both nasal cavities can be correlated in part to the trauma from mucosal adhesion and in part to the type of material used. Two patients with s-pva needed repositioning of the packs due to significant bleeding, whereas the bleeding ratio of all patients in group C was higher compared to the other two groups. The s-pva, which seems to involve major mucosal adhesion, leads to greater mucosal friction with more significant bleeding. 20 On the other hand, the pf-pva provided with laminated sides, resulting in less adhesion to the wounded nasal mucosa, had a lower bleeding ratio than the s-pva but higher bleeding compared to the oc-pva. The pf-pva does not adhere to the mucosa; but as opposed to the oc-pva, it does not contain a hemostatic agent to provide sufficient hemostasis, resulting in an intermediate bleeding ratio. The oc-pva is more abrasive than the pf-pva and theoretically should lead to major bleeding. However, our results showed that the oc-pva had the best bleeding control. This was statistically significant (P ) and probably due to the oxidized cellulose contained in the PVA sponge, which has hemostatic properties. CONCLUSION Surgical practices concerning the use of nasal packing after FESS vary widely. Several different types of topical packing agents are being used, each with inherent advantages and disadvantages. Our study evaluated three different PVA nasal packs (equally effective in preventing postoperative bleeding while in situ),

5 demonstrating that the pf-pva is less painful than the others but with intermediate bleeding ratio during removal. On the other hand, the oc-pva has an intermediate pain score but excellent bleeding control. The s- PVA showed the worst bleeding and pain outcomes. Considering that removal of the second pack (from the middle meatus) is more painful than the first one (from the nasal fossa), our results suggest that a pf-pva pack can be placed in the middle meatus, and a oc-pva pack in the nasal fossa, in order to reduce patient discomfort in terms of pain and bleeding. Acknowledgment Luca Volpi, MD, is a student in the PhD program in Molecular Oncology, School of Biological and Medical Sciences, University of Sassari, Sassari, Italy. BIBLIOGRAPHY 1. Stammberger H, Posawetz W. Functional endoscopic sinus surgery. Concept, indications and results of the Messerklinger technique. Eur Arch Otorhinolaryngol 1990;247: Thaler ER. Postoperative care after endoscopic sinus surgery. Arch Otolaryngol Head Neck Surg 2002;128: Fenu G, Bozzo C, Carai A, Delehaye E, Foddai M, Meloni F, Montella AC. Effects of isotonic salso-bromo-iodine thermal water after sinunasal surgery: a preliminary morphological study. J Altern Complement Med 2010;16: Erratum: 2010;16: Bugten V, Nordgard S, Skogvoll E, Steinsvag S. Effects of nonabsorbable packing in middle meatus after sinus surgery. Laryngoscope 2006;116: Eliashar R, Gross M, Wohlgelernter J, Sichel JY. Packing in endoscopic sinus surgery: is it really required? Otolaryngol Head Neck Surg 2006; 134: Seol JH, Kim JM, Kim SS, Na BR, Jung H, Cho JH, Kim JK. Comparison of polyvinyl alcohol coated nasal packing with non-absorbable nasal packing. Rhinology 2013;51: Chandra RK, Kern RC. Advantages and disadvantages of topical packing in endoscopic sinus surgery. Curr Opin Otolaryngol Head Neck Surg 2004;12: Weber R, Keerl R, Hochapfel F, Draf W, Toffel PH. Packing in endonasal surgery. Am J Otolaryngol 2001;22: Kuo MJ, Zeitoun H, Macnamara M, Wagstaff K, Carlin WV, Turner N. The use of topical 5% lignocaine ointment for the relief of pain associated with post-operative nasal packing. Clin Otolaryngol Allied Sci 1995;20: Akbari E, Philpott CM, Ostry AJ, Clark A, Javer AR. A double-blind randomised controlled trial of gloved versus ungloved merocel middle meatal spacers for endoscopic sinus surgery. Rhinology 2012;50: Shoman N, Gheriani H, Flamer D, Javer A. Prospective, double-blind, randomized trial evaluating patient satisfaction, bleeding, and wound healing using biodegradable synthetic polyurethane foam (NasoPore) as a middle meatal spacer in functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg 2009;38: Arya AK, Butt O, Nigam A. Double-blind randomised controlled trial comparing Merocel with Rapid Rhino nasal packs after routine nasal surgery. Rhinology 2003;41: Chevillard C, Rugina M, Bonfils P, et al. Evaluation of calcium alginate nasal packing (Algosteril) versus Polyvinyl acetal (Merocel) for nasal packing after inferior turbinate resection. Rhinology 2006;44: Berlucchi M, Castelnuovo P, Vincenzi A, Morra B, Pasquini E. Endoscopic outcomes of resorbable nasal packing after functional endoscopic sinus surgery: a multicenter prospective randomized controlled study. Eur Arch Otorhinolaryngol 2008;266: Weber R. Nasal packing and stenting. GMS Curr Top Otorhinolaryngol Head Neck Surg 2009;8:Doc Fanous N. The absorbable nasal pack. J Otolaryngol 1980;9: Ong KS, Seymour RA. Pain measurement in humans. Surgeon 2004;2: Bresnihan M, Mehigan B, Curran A. An evaluation of Merocel and Series 5000 nasal packs in patients following nasal surgery: a prospective randomized trial. Clin Otolaryngol 2007;32: McDonald SE, Slater J, Powell R, Khalil HS, Garth RJN. Randomized controlled trial comparing Rapid Rhino Mannheim and Netcell Series 5000 packs following routine nasal surgery. Rhinology 2009;47: Acioglu E, Edizer DT, Yigit O, Omur F, Alkan Z. Nasal septal packing: which one? Eur Arch Otorhinolaryngol 2011;269: