Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure

NCT02981017 | Withdrawn

• 1 other identifier: 16-001257
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Sinusitis; Frontal Sinusitis

Keywords

Chronic sinusitis; Frontal sinusitis; Skull base neoplasm

Outcome Measures

Primary Outcomes (1)

• Frontal sinus stenosis

  Evaluate the size of the frontal sinus outflow tract over one year after surgery

  1 year

Secondary Outcomes (5)

• Number of postoperative debridements

  1 year

• Need for further surgical intervention

  1 year

• Number of postoperative infections

  1 year

• Lund Kennedy Endoscopy Score

  1 year

• SNOT-22 score

  1 year

Study Arms (2)

Control

NO INTERVENTION

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.

Cook Biodesign

EXPERIMENTAL

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

Interventions

Porcine Intestinal submucosal xenograft DEVICE

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.

Also known as: Cook Biodesign ENT Repair

Cook Biodesign

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous Draf III or Endoscopic Modified Lothrop Procedure
• Allergy or objection to use of porcine-based graft material

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Related Publications (12)

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  PMID: 19645319 BACKGROUND

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  PMID: 22253224 BACKGROUND

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  PMID: 23900802 BACKGROUND

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  PMID: 19554631 BACKGROUND

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  PMID: 17585278 BACKGROUND

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  PMID: 25079177 BACKGROUND

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  PMID: 24609647 BACKGROUND

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  PMID: 22228601 BACKGROUND

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  PMID: 22487293 BACKGROUND

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  PMID: 23452383 BACKGROUND

• Wei CC, Sama A. What is the evidence for the use of mucosal flaps in Draf III procedures? Curr Opin Otolaryngol Head Neck Surg. 2014 Feb;22(1):63-7. doi: 10.1097/MOO.0000000000000023.

  PMID: 24335916 BACKGROUND

MeSH Terms

Conditions

Frontal Sinusitis; Skull Base Neoplasms

Condition Hierarchy (Ancestors)

Sinusitis; Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Skull Neoplasms; Bone Neoplasms; Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jeffrey D Suh, MD

  University of California Los Angeles, Department of Head and Neck Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Head and Neck Surgery

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 2, 2016
• Study Start: November 1, 2016
• Primary Completion: December 28, 2019
• Study Completion: December 28, 2019
• Last Updated: October 30, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)