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Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure

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ClinicalTrials.gov Identifier: NCT02981017
Recruitment Status : Recruiting
First Posted : December 2, 2016
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Jeffrey D. Suh, University of California, Los Angeles

Study Description
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Brief Summary:
We propose a randomized, single-blinded, prospective trial in order to evaluate the efficacy of the Cook Biodesign ENT Repair graft in improving outcomes after the Draf III or Endoscopic Modified Lothrop procedure. The Cook Biodesign ENT Repair graft is a porcine intestinal submucosal xenograft which has been FDA approved for use as an adjunct to natural healing process in the sinonasal cavity. The Draf III or Endoscopic Modified Lothrop involved creating a large unified drainage pathway for refractory frontal sinusitis. After the procedure is completed, there is exposed bone along the frontal beak region which can become a nidus for inflammation, crusting and eventual scarring, leading to stenosis or even complete blockage of the frontal sinuses. The Cook Biodesign will be used to cover this exposed bone in order to potentially reduce the inflammation, crusting and scarring and possibly improve outcomes.

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Frontal Sinusitis Device: Porcine Intestinal submucosal xenograft Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective Study for Improvement in Outcomes Following Draf III/Endoscopic Modified Lothrop Procedure Using a Porcine Intestinal Submucosal Graft
Study Start Date : November 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Sinusitis

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Subjects within the control arm will undergo the Draf III/Endoscopic Modified Lothrop procedure to address their sinus disease. At the end of the procedure, no Cook Biodesign Porcine intestinal submucosal graft will be used to cover the operative site. Light nasal packing will be placed in the nasal cavity for hemostasis. No placebo will be utilized.
Experimental: Cook Biodesign
Subjects within the experimental group will undergo the Draf III/Endoscopic Modified Lothrop procedure to address their sinus disease. At the end of the procedure, a small piece of Cook Biodesign porcine intestinal submucosal xenograft will be used to cover the exposed bone of the operative site along the frontal beak. It will be bolstered with light nasal packing to keep the graft in place during healing.
 Device: Porcine Intestinal submucosal xenograft
Cook Biodesign ENT repair graft will be used in the experimental group to cover exposed bone in the sinonasal cavity as a result of the Draf III/endoscopic modified lothrop procedure.
Other Name: Cook Biodesign ENT Repair


Outcome Measures
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Primary Outcome Measures :
  1. Frontal sinus stenosis [ Time Frame: 1 year ]
    Evaluate the size of the frontal sinus outflow tract over one year after surgery


Secondary Outcome Measures :
  1. Number of postoperative debridements [ Time Frame: 1 year ]
    Track the number of debridements required in the postoperative period

  2. Need for further surgical intervention [ Time Frame: 1 year ]
    Track if any further surgical procedures (in office or in operating room) that are required during postoperative period

  3. Number of postoperative infections [ Time Frame: 1 year ]
    Track the number of postoperative sinus infections, proven by culture, as well as the number of antibiotic courses required for treatment.

  4. Lund Kennedy Endoscopy Score [ Time Frame: 1 year ]
    Evaluation of the sinuses using nasal endoscopy and objective measurement using the validated Lund-Kennedy Endoscopy score

  5. SNOT-22 score [ Time Frame: 1 year ]
    Evaluation of patient quality of life using a validated questionnaire called the Sinonasal Outcome Test (SNOT) - 22.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient older than 18 years of age
  • Frontal sinusitis refractory to previous surgical and/or medical therapy
  • Patient with skull base neoplasm which requires Draf III or Endoscopic Modified Lothrop for exposure in excision of tumor

Exclusion Criteria:

  • Previous Draf III or Endoscopic Modified Lothrop Procedure
  • Allergy or objection to use of porcine-based graft material
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02981017


Contacts
Contact: Frederick Yoo, MD 3102066766 ext p29992 fyoo@mednet.ucla.edu
Contact: Jeffrey D Suh, MD 3102066766 jeffsuh@mednet.ucla.edu

Locations
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Frederick Yoo, MD    310-206-6766 ext p29992    fyoo@mednet.ucla.edu   
Contact: Jeffrey D Suh, MD    3102066766    jeffsuh@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Jeffrey D Suh, MD University of California Los Angeles, Department of Head and Neck Surgery
More Information
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Publications:

Responsible Party: Jeffrey D. Suh, Assistant Professor, Department of Head and Neck Surgery, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02981017     History of Changes
Other Study ID Numbers: 16-001257
First Posted: December 2, 2016    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jeffrey D. Suh, University of California, Los Angeles:
Chronic sinusitis
Frontal sinusitis
Skull base neoplasm

Additional relevant MeSH terms:
Sinusitis
Chronic Disease
Frontal Sinusitis
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes