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

Chul Chang, Sung Moon Hong, Jin Hee Cho, Sang Yul Shim, Jung Sun Cho, Heung Man Lee

Research output: Contribution to journalArticle

5 Citations (Scopus)

Abstract

Objectives. 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). Conclusion. HyFence has equivalent anti-adhesion effect compared to Guardix-Sol following ESS.

Original languageEnglish
Pages (from-to)30-35
Number of pages6
JournalClinical and Experimental Otorhinolaryngology
Volume7
Issue number1
DOIs
Publication statusPublished - 2014 Feb 27

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Safety
Polymethyl Methacrylate
Hyaluronic Acid
Edema
Infection
Clinical Studies
Ether
Wound Healing
Cicatrix
guardix
Water
Incidence
polyvinyl alcohol formaldehyde foam

Keywords

  • Adhesion
  • Anti-adhesion agent
  • Complication
  • Endoscopic sinus surgery
  • Hyaluronic acid

ASJC Scopus subject areas

  • Otorhinolaryngology
  • Surgery

Cite this

@article{6d97c0de342d4c87940f3706c08fe6f3,
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 = "Objectives. 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). Conclusion. HyFence has equivalent anti-adhesion effect compared to Guardix-Sol following ESS.",
keywords = "Adhesion, Anti-adhesion agent, Complication, Endoscopic sinus surgery, Hyaluronic acid",
author = "Chul Chang and Hong, {Sung Moon} and Cho, {Jin Hee} and Shim, {Sang Yul} and Cho, {Jung Sun} and Lee, {Heung Man}",
year = "2014",
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volume = "7",
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journal = "Clinical and Experimental Otorhinolaryngology",
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T1 - 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

AU - Chang, Chul

AU - Hong, Sung Moon

AU - Cho, Jin Hee

AU - Shim, Sang Yul

AU - Cho, Jung Sun

AU - Lee, Heung Man

PY - 2014/2/27

Y1 - 2014/2/27

N2 - Objectives. 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). Conclusion. HyFence has equivalent anti-adhesion effect compared to Guardix-Sol following ESS.

AB - Objectives. 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). Conclusion. HyFence has equivalent anti-adhesion effect compared to Guardix-Sol following ESS.

KW - Adhesion

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KW - Endoscopic sinus surgery

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