Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure - Full Text View

Purpose

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	Intervention	Phase
Chronic Sinusitis Frontal Sinusitis	Device: Porcine Intestinal submucosal xenograft	Phase 4


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Sinusitis

U.S. FDA Resources

Further study details as provided by Jeffrey D. Suh, University of California, Los Angeles:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Number of postoperative debridements [ Time Frame: 1 year ]
Track the number of debridements required in the postoperative period
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
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.
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
SNOT-22 score [ Time Frame: 1 year ]
Evaluation of patient quality of life using a validated questionnaire called the Sinonasal Outcome Test (SNOT) - 22.


Estimated Enrollment:	50
Study Start Date:	November 2016
Estimated Study Completion Date:	December 2018
Estimated Primary Completion Date:	December 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

Show Detailed Description

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

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: 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

Publications:

Pleis JR, Lucas JW. Summary health statistics for U.S. adults: National Health Interview Survey, 2007. Vital Health Stat 10. 2009 May;(240):1-159.

Naidoo Y, Wen D, Bassiouni A, Keen M, Wormald PJ. Long-term results after primary frontal sinus surgery. Int Forum Allergy Rhinol. 2012 May-Jun;2(3):185-90. doi: 10.1002/alr.21015. Epub 2012 Jan 17.

Pynnonen MA, Davis MM. Extent of sinus surgery, 2000 to 2009: a population-based study. Laryngoscope. 2014 Apr;124(4):820-5. doi: 10.1002/lary.24335. Epub 2013 Oct 2.

Anderson P, Sindwani R. Safety and efficacy of the endoscopic modified Lothrop procedure: a systematic review and meta-analysis. Laryngoscope. 2009 Sep;119(9):1828-33. doi: 10.1002/lary.20565. Review.

Wormald PJ. Salvage frontal sinus surgery: the endoscopic modified Lothrop procedure. Laryngoscope. 2003 Feb;113(2):276-83.

Tran KN, Beule AG, Singal D, Wormald PJ. Frontal ostium restenosis after the endoscopic modified Lothrop procedure. Laryngoscope. 2007 Aug;117(8):1457-62.

Ye T, Hwang PH, Huang Z, Huang Q, Xian J, Li C, Zhou B. Frontal ostium neo-osteogenesis and patency after Draf III procedure: a computer-assisted study. Int Forum Allergy Rhinol. 2014 Sep;4(9):739-44. doi: 10.1002/alr.21357. Epub 2014 Jul 30.

AlQahtani A, Bignami M, Terranova P, Digilio E, Basilico F, Abdulrahman S, Castelnuovo P. Newly designed double-vascularized nasoseptal flap to prevent restenosis after endoscopic modified Lothrop procedure (Draf III): laboratory investigation. Eur Arch Otorhinolaryngol. 2014 Nov;271(11):2951-5. doi: 10.1007/s00405-014-2961-2. Epub 2014 Mar 8.

Conger BT Jr, Riley K, Woodworth BA. The Draf III mucosal grafting technique: a prospective study. Otolaryngol Head Neck Surg. 2012 Apr;146(4):664-8. doi: 10.1177/0194599811432423. Epub 2012 Jan 6.

Hildenbrand T, Wormald PJ, Weber RK. Endoscopic frontal sinus drainage Draf type III with mucosal transplants. Am J Rhinol Allergy. 2012 Mar-Apr;26(2):148-51. doi: 10.2500/ajra.2012.26.3731.

Seyedhadi S, Mojtaba MA, Shahin B, Hoseinali K. The Draf III septal flap technique: a preliminary report. Am J Otolaryngol. 2013 Sep-Oct;34(5):399-402. doi: 10.1016/j.amjoto.2013.01.019. Epub 2013 Feb 26.

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. Review.


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
Study First Received:	November 30, 2016
Last Updated:	November 30, 2016
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

ClinicalTrials.gov processed this record on August 18, 2017