Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery
Condition: Sinusitis
MeSH terms: Sinusitis
Intervention: Restora™ Steroid eluting spacer; Silastic Silicone Spacer
Intervention description: The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.; The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: Single (Participant)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Middle Meatus; Synechiae; Endoscopic Sinus Surgery; Silastic spacer; Restora™ steroid eluting MM spacer

Summary:

      Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic
      rhinosinusitis that is not adequately controlled with maximal medical therapy.

      In some patients, underlying inflammation (discharge, edema and polyposis), compounded by
      inflammation caused by surgical trauma may lead to an uncontrolled healing response, which
      results in the synechiae formation in the middle meatus (MM).

      Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of
      middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic
      visualization of the sinus cavities postoperatively. This may result in difficulty in
      performing postoperative routine endoscopic debridement and examination, which is paramount
      to a successful outcome from ESS. Spacers are often inserted during surgery between nasal
      mucosal surfaces to prevent synechiae.

      The aim of this study is to see if a steroid-impregnated spacer is more effective at reducing
      inflammation after sinus surgery than a Silastic spacer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age between 18 and 75 years

          2. Diagnosis of chronic rhinosinusitis (CRS), per current guidelines

          3. Patients who need to undergo primary bilateral complete endoscopic sinus surgery

          4. Subject has the ability to follow the study instructions, is willing to be available
             on the specific required study visit days, and is willing to complete all study visit
             procedures and assessments

          5. Subject must understand the research nature of this study and sign an informed consent
             prior to the performance of any study-specific procedure or assessment

        Exclusion Criteria:

          1. Subject is pregnant or breast feeding

          2. Patients with sino-nasal tumors

          3. Patients solely undergoing nasal septal reconstruction

          4. Patients with previous history of endoscopic sinus surgery

          5. Cystic fibrosis or syndromic patients

          6. Patients with autoimmune diseases

          7. Patients who have taken oral steroids less than 30 days prior to surgery

          8. Patients with a history or diagnosis of glaucoma or ocular hypertension

          9. Any other circumstance or condition that in the Investigator's opinion causes the
             subject to be an inappropriate candidate for participating in this study