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CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
Sepragel sinus (hylan B) as a postsurgical dressing for endoscopic sinus surgery.
Otolaryngology - Head and Neck Surgery 2001 December
OBJECTIVE: To assess the safety and efficacy of Sepragel sinus, a hylan B gel (cross-linked hyaluronic acid molecule), when used as a postoperative dressing after endoscopic sinus surgery as a facilitator of healing and a preventative for scarring and stenosis.
STUDY DESIGN: Ten patients undergoing bilateral endoscopic ethmoidectomy in an outpatient specialty hospital operating room underwent complete filling of a randomly selected right or left ethmoidectomy cavity with Sepragel sinus. Outcome measures were synechiae, middle meatal stenosis, mucosal status, mucosal regeneration, transparency of Sepragel sinus, and subjective pain and congestion.
RESULTS: Sepragel sinus significantly improved all outcome measures by week 2 and remained statistically significant for reduction of synechiae and stenosis.
CONCLUSION: Sepragel sinus is useful as a space-occupying gel stent to separate sinus mucosal surfaces. The data strongly support the superiority of Sepragel sinus over no treatment in the control of postethmoidectomy synechiae and middle meatal stenosis, as well as early improvement in mucosal healing and postoperative pain.
SIGNIFICANCE: Because of its biocompatibility, lack of inflammatory response, transparency, and ability to fill any complex volume, Sepragel sinus offers distinct advantages over currently used stenting materials.
STUDY DESIGN: Ten patients undergoing bilateral endoscopic ethmoidectomy in an outpatient specialty hospital operating room underwent complete filling of a randomly selected right or left ethmoidectomy cavity with Sepragel sinus. Outcome measures were synechiae, middle meatal stenosis, mucosal status, mucosal regeneration, transparency of Sepragel sinus, and subjective pain and congestion.
RESULTS: Sepragel sinus significantly improved all outcome measures by week 2 and remained statistically significant for reduction of synechiae and stenosis.
CONCLUSION: Sepragel sinus is useful as a space-occupying gel stent to separate sinus mucosal surfaces. The data strongly support the superiority of Sepragel sinus over no treatment in the control of postethmoidectomy synechiae and middle meatal stenosis, as well as early improvement in mucosal healing and postoperative pain.
SIGNIFICANCE: Because of its biocompatibility, lack of inflammatory response, transparency, and ability to fill any complex volume, Sepragel sinus offers distinct advantages over currently used stenting materials.
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