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Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery

This study has been terminated.
(Due to financial issues of Restora spacer company.)
Sponsor:
Information provided by (Responsible Party):
Martin L. Hopp, MD, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT02627794
First received: December 7, 2015
Last updated: February 16, 2017
Last verified: February 2017
  Purpose

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.


Condition Intervention Phase
Sinusitis Device: Restora™ Steroid eluting spacer Device: Silastic Silicone Spacer Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Rates of Middle Meatus (MM) Synechiae Formation Post Endoscopic Sinus Surgery (ESS): A Double-blind Randomized Controlled Study Comparing Silastic and Restora™ Steroid Eluting MM Spacer

Resource links provided by NLM:


Further study details as provided by Martin L. Hopp, MD, Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Incidence of middle meatal synechiae after endoscopic sinus surgery in silastic and Restora steroid eluting spacer. [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    The main objective of the trial is to evaluate basic device usability and confirm safety and effectiveness of Restora™ Mometasone Furoate eluting spacer as compared to a Silastic spacer. 35-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system.


Secondary Outcome Measures:
  • 90-day sinonasal mucosal inflammation assessment [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    90-day sinonasal mucosal inflammation assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system

  • 35 and 90-day intraocular pressure (IOP) assessment [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    35 and 90-day intraocular pressure (IOP) assessed using applanation tonometry and compared to baseline IOP obtained preoperatively

  • 35 and 90-day post ESS incidence of middle meatal synechiae [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    35 and 90-day post ESS incidence of middle meatal synechiae

  • 90-day Sinonasal Outcomes Test-22 (SNOT- 22) scores [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    90-day Sinonasal Outcomes Test-22 (SNOT- 22) scores

  • 35-day frequency of postoperative interventions [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    35-day frequency of postoperative interventions, including lyses of adhesions and debridement.

  • 35-day frequency of oral steroid rescue [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    35-day frequency of oral steroid rescue

  • 35 days middle turbinate position [ Time Frame: Participants will be followed for the duration of post op standard of care, an expected average of 90 days. ]
    35 days middle turbinate position


Enrollment: 3
Actual Study Start Date: December 2015
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Silastic Silicone spacer
Silastic Silicone spacers are actively being used as the standard of care.
Device: Silastic Silicone Spacer
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.
Other Name: Control Arm
Experimental: Restora™ Steroid eluting spacer
This study arm receives the experimental treatment, a Restora™ Steroid eluting spacer.
Device: Restora™ Steroid eluting spacer
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.
Other Name: Experimental arm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02627794

Locations
United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Martin L Hopp, MD Cedars-Sinai Medical Center
  More Information

Responsible Party: Martin L. Hopp, MD, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02627794     History of Changes
Other Study ID Numbers: Pro00039737
Study First Received: December 7, 2015
Last Updated: February 16, 2017

Keywords provided by Martin L. Hopp, MD, Cedars-Sinai Medical Center:
Middle Meatus
Synechiae
Endoscopic Sinus Surgery
Silastic spacer
Restora™ steroid eluting MM spacer

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on August 18, 2017