A Prospective Double-Blinded Randomized Controlled Study Comparing the Efficacy of a Novel Biodegradable Synthetic Polyurethane Foam (Nasopore) vs Standard Polyvinyl Acetate Sponge (Merocel) as Packing Material after Functional Endoscopic Sinus Surgery: The First Indian Experience

Abstract

ABSTRACT Background In Indian clinical practice, conventional nasal packing for hemostasis after routine rhinological surgery is usually performed with Vaseline (paraffin) gauze, and rarely with glove-finger packs or tamponade balloons. These materials are tedious to pack and cause discomfort to the patient on removal. 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. Most rhinologists today, prefer to use polyvinyl acetate sponge packs (Merocel/Ivalon) for tamponade after nasal surgery. These packs are very effective but non-absorbable and need to be removed which does not augur well with many patients postoperatively. The recent entry of a biodegradable synthetic polyurethane foam (Nasopore) as an alternative nasal packing material, has evoked new interest, which initiated this study. Study method This prospective randomized double-blinded controlled study was aimed to compare the clinical efficacy and patient comfort level, while using Merocel and Nasopore as packing material after functional endoscopic sinus surgery (FESS). This study included thirty adults who were diagnosed with moderate to severe bilaterally comparable chronic rhinosinusitis, who underwent FESS under general anesthesia and received size-matched nasal packs randomly - Merocel on one side and Nasopore on the other. The assessment of clinical efficacy of both packs with regards to ease of packing, hemostasis, pressure effects, infections and adhesions was done with a Diagnostic Nasal Endoscopy at first postoperative day, first week and fourth week after surgery. All Merocel packs were removed on the first postoperative day. Patient comfort levels for both packs were recorded with a standard symptom questionnaire marked on a visual analogue scale of ten and the results were statistically compared between the two groups. Results Comparable outcomes were found while using Merocel or Nasopore with regards to ease of nasal packing and control of postoperative bleeding. There was a statistical difference in the hemostatic property between the two materials in the immediate postoperative period. Five out of 30 patients developed reactionary bleeds with Nasopore, which required repacking with same material within the first 24 hours, but no further bleeds were noted. Two out of these five patients on the first postoperative day had migration of Nasopore toward the choana and had to be repacked with additional Nasopore. Sequential postoperative nasal endoscopy revealed that Nasopore is more mucosal friendly with lesser incidence of adhesions, synechiae, infection and edema, with better biocompatibility and safety. The major success with Nasopore was found to be, the fact that no pack removal was necessary, which immensely improved patient satisfaction and willingness to use the material when compared to Merocel. This was proved by the patient's symptom questionnaire which showed significant benefits of Nasopore over Merocel with regards to compliance and comfort levels. Conclusion Nasopore is a novel biodegradable synthetic material which is clinically as efficacious and patient-friendly as Merocel and is suitable for postoperative nasal packing after functional endoscopic sinus surgery. The clinical benefits of Nasopore and its outcomes among patients as recorded in our study, stands proof to support Nasopore as a successful packing material in rhinological surgery. How to cite this article Raghunandhan S, Kameswaran M, Thomas JK. A Prospective Double-Blinded Randomized Controlled Study Comparing the Efficacy of a Novel Biodegradable Synthetic Polyurethane Foam (Nasopore) vs Standard Polyvinyl Acetate Sponge (Merocel) as Packing Material after Functional Endoscopic Sinus Surgery: The First Indian Experience. Clin Rhinol An Int J 2014;7(3):105-111.