Clin Exp Otorhinolaryngol.  2014 Mar;7(1):30-35.

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

• Chang C
• Hong SM
• Cho JH
• Shim SY
• Cho JS
• Lee HM

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.

Keyword

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

MeSH Terms

Cicatrix
Edema
Ether
Humans
Hyaluronic Acid
Incidence
Postoperative Complications
Wound Healing
Ether
Hyaluronic Acid

Figure

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  Fig. 1 HyFence LV contained in a syringe.

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  Fig. 2 Grading of the severity of adhesions. Group (G) 0 indicates no adhesion (A). G1 indicates adhesions without limitation of sinus ventilation (B). G2 indicates adhesions with limitation of sinus ventilation (C). G3 indicates total adhesion between the middle turbinate and lateral nasal wall (D).

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  Fig. 3 Incidence of postoperative adhesions in HyFence LV (A) and Guardix-Sol (B).

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  Fig. 4 The effectiveness of HyFence LV (Pt) and Guardix-Sol (Pc).

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