Clinical Trial: Rates of Middle Meatus Synechiae Formation Post ESS

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS)

Brief Summary: The study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.

Detailed Summary:

The study is designed to evaluate basic device usability and confirm safety and effectiveness of the Restora Steroid Eluting spacer compared to a Silastic spacer.

At the completion of their procedure, patients undergoing ESS will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without drug placed on the other side. Patients will return for standard post-op visits. Between post-op day 6 and 8, both spacers will be removed. Patients will again be seen on post-op day 35 and 90 to evaluate the surgical sites with respect to healing, scarring, infection, degree of inflammation, polyp formation, and the need for secondary intervention. Data from the two sides will be compared to determine if there is a benefit derived from the spacer with steroid vs the one without.


Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

Current Primary Outcome: Incidence of middle meatal synechiae [ Time Frame: 90 days ]

Safety and effectiveness of steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • sinonasal mucosal inflammation [ Time Frame: 90 days ]
    35 and 90-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on both the Philpott-Javer and Modified Lund-Kennedy sinus mucosal endoscopic staging systems
  • intraocular pressure (IOP) [ Time Frame: 90 days ]
    35 and 90-day intraocular pressure (IOP) will be assessed using applanation tonometry and compared to baseline IOP obtained preoperatively
  • postoperative interventions [ Time Frame: 35 days ]
    35-day frequency of postoperative interventions, including lyses of adhesions and debridement.
  • SNOT-22 Questionnaire [ Time Frame: 90 days ]
    90-day validated Sinonasal Outcomes Test-22 (SNOT- 22) scores


Original Secondary Outcome: Same as current

Information By: Steward St. Elizabeth's Medical Center of Boston, Inc.

Dates:
Date Received: May 4, 2015
Date Started: May 2015
Date Completion:
Last Updated: January 31, 2017
Last Verified: January 2017