title: A Randomized, Multi-Center, Single Blind, Active-Controlled, Matched Pairs Clinical Study to Evaluate Prevention of Adhesion Formation and Safety of HyFence in Patients After Endoscopic Sinus Surgery.
abstract: OBJECTIVE
  Recurrent mucosal disease and anatomic obstruction are commonly cited causes of failed endoscopic sinus surgery (ESS). Hyaluronic acid (HA) has been reported to reduce scarring and to promote wound healing in sinonasal surgery. HyFence is HA stabilized by 1, 4-butandiol diglycidyl ether, which makes it less-water-soluble and highly viscoelastic. The purpose of this study is to examine the anti-adhesion effect of HyFence after ESS compared to that of HA-CMC (Guardix-Sol).
  
  
  METHODS
  Seventy-four patients with chronic rhinosinusitis who underwent ESS were included in the study. After the ESS procedure, Merocel was placed in the ethmoidectomized areas of the both sides. Five milliliters of Guardix-Sol was then applied to the Merocel of one side and HyFence LV was applied to the other side. The effect of the agents was evaluated at one, two, and four weeks after surgery by endoscopic examination. The severity of adhesion, edema, infection and complications were evaluated.
  
  
  RESULTS
  There was no significant difference in the incidence of postoperative adhesion between the HyFence group and the Guardix-Sol group (P>0.05). Mean postoperative grades of edema and infection showed no significant difference between groups (P>0.05). There was no significant postoperative complications associated with either anti-adhesion agent (P>0.05).
  
  
  CONCLUSIONS
  HyFence has equivalent anti-adhesion effect compared to Guardix-Sol following ESS.
authors.affiliation: Department of Otorhinolaryngology, Bundang CHA Hospital, Cha University College of Medicine, Seongnam, Korea.
authors.forename: Chul
authors.initials: C
authors.lastname: Chang
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Korea University Guro Hospital, Seoul, Korea. ; Medical Devices Clinical Trial Center, Korea University Guro Hospital, Seoul, Korea.
authors.forename: Sung-Moon
authors.initials: SM
authors.lastname: Hong
authors.affiliation: Department of Otolaryngology-Head and Neck Surgery, St. Mary's Hospital, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors.forename: Jin-Hee
authors.initials: JH
authors.lastname: Cho
authors.affiliation: Department of Otorhinolaryngology, Bundang CHA Hospital, Cha University College of Medicine, Seongnam, Korea.
authors.forename: Sang Yul
authors.initials: SY
authors.lastname: Shim
authors.affiliation: Medical Devices Clinical Trial Center, Korea University Guro Hospital, Seoul, Korea.
authors.forename: Jung-Sun
authors.initials: JS
authors.lastname: Cho
authors.affiliation: Department of Otorhinolaryngology-Head and Neck Surgery, Korea University Guro Hospital, Seoul, Korea. ; Medical Devices Clinical Trial Center, Korea University Guro Hospital, Seoul, Korea.
authors.forename: Heung-Man
authors.initials: HM
authors.lastname: Lee
keywords: Adhesion; Anti-adhesion agent; Complication; Endoscopic sinus surgery; Hyaluronic acid