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Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02627794
Recruitment Status : Terminated (Due to financial issues of Restora spacer company.)
First Posted : December 11, 2015
Results First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Martin L. Hopp, MD, Cedars-Sinai Medical Center

Tracking Information
First Submitted Date  ICMJE December 7, 2015
First Posted Date  ICMJE December 11, 2015
Results First Submitted Date  ICMJE April 10, 2017
Results First Posted Date  ICMJE November 17, 2017
Last Update Posted Date November 17, 2017
Actual Study Start Date  ICMJE December 2015
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery
Official Title  ICMJE 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
Brief 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.

Detailed Description

Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic rhinosinusitis that is not adequately controlled with medical therapy. Synechiae formation in the middle meatus is the most common complication of endoscopic sinus surgery. Synechiae describes the adhesion of two opposing mucosal surfaces in the nasal cavity that can cause scarring and obstruction of the nasal passage. 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.

To prevent synechiae formation, numerous studies have been published evaluating the effectiveness of absorbable and non-absorbable spacers placed in the middle meatus for 1-2 weeks postoperatively. The spacer is meant to prevent contact between the denuded surfaces of the middle turbinate and the lateral nasal wall during re-epithelialization. In general, non-resorbable spacers that have been used include sponges, cotton gauze and plastic sheets. Of these, Silastic Silicone sheets have been used in a number of hospitals across the US and Canada. Lee and Baguley have demonstrated the effectiveness of Silastic spacers in reducing the risk of synechiae formation to between 0-6 %. There are also a number of resorbable spacers that are in use, which are preferred by some physicians because there is minimal need to remove the packing materials as they naturally are removed or resorbed during the healing period.

In a recent meta-analysis, Lee et al has revealed that usage of middle meatal spacers (absorbable and non-absorbable) did not decrease the rate of synechiae formation to a statistically significant degree compared to not using any spacer. However, when subgroup analysis was performed, non-absorbable spacer usage demonstrated a statistically significant lower incidence of synechiae compared to no spacers. This can be explained in part by an inherent capability of the absorbable spacer material to degrade to smaller size particulates that, if caught in the healing tissue, could illicit local inflammatory response to slow down the healing and cause further synechiae formation. This mechanism was demonstrated by Maccabee et al in a rabbit model, where fibers of the absorbable spacer became incorporated into healing mucosa and increased the extent of the inflammatory response and formation of fibrosis.

To improve outcomes, physicians have attempted to load steroids such as Triamcinolone and antibiotics such as Neosporin into nasal packing and/or stents. However, residence of the drug in the intended treatment space is minimized as the drug, which is not bound to the spacer, quickly releases and may not remain long enough to impact inflammatory response. A Mometasone Furoate coated stent (Propel™), manufactured by Intersect ENT, is currently the only drug coated nasal stent that has a claim of longer sustained release. In a randomized, controlled, double-blind trial, Marple et al found that this Mometasone Furoate steroid-eluting bio-absorbable stent could significantly improve postoperative outcomes compared to a non-steroid eluting placebo arm with the same stent. Zhao et al conducted a systematic review of the efficacy of this steroid-eluting stent (Propel) vs inert (both resorbable and non-resorbable) spacers and again confirmed that there are lower rates of synechiae formation in the steroid-eluting treatment groups. However, anecdotal evidence, based on discussion with a number of surgeons in the field, suggests that a drug-loaded resorbable spacer may be subject to the same issues as non-drug-loaded resorbable spacers, namely late stage degradation of the material that can cause a secondary spike of the inflammatory cascade, requiring additional surgical intervention to remove the remaining debris.

Therefore, it has been hypothesized that a steroid eluting non-absorbable spacer may provide optimal benefit for the patient's outcome. The Restora™ spacer is made of a biocompatible non-resorbable material that is expected to deliver up to 370 µg of Mometasone Furoate. The steroid elutes out of the spacer and onto the surrounding mucosal tissue during the 6-8 day period during which it is retained.

This study is designed to evaluate basic device usability and confirm safety and effectiveness of the Restora™ Steroid eluting spacer as compared to the standard of care Silastic Silicone spacer.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Sinusitis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE Experimental: Silastic Silicone & Restora™ Steroid eluting spacer

Silastic Silicone spacers are actively being used as the standard of care.

Restora™ Steroid eluting spacer (experimental).

Each nostril will receive one each of above spacers.

Interventions:
  • Device: Restora™ Steroid eluting spacer
  • Device: Silastic Silicone Spacer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 16, 2017)
3
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2015)
30
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02627794
Other Study ID Numbers  ICMJE Pro00039737
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Martin L. Hopp, MD, Cedars-Sinai Medical Center
Study Sponsor  ICMJE Cedars-Sinai Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin L Hopp, MD Cedars-Sinai Medical Center
PRS Account Cedars-Sinai Medical Center
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP