Chronic Sinusitis Clinical Trial
Official title:
Prospective Study for Improvement in Outcomes Following Draf III/Endoscopic Modified Lothrop Procedure Using a Porcine Intestinal Submucosal Graft
Verified date | October 2020 |
Source | University of California, Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 28, 2019 |
Est. primary completion date | December 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of California Los Angeles | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Tran KN, Beule AG, Singal D, Wormald PJ. Frontal ostium restenosis after the endoscopic modified Lothrop procedure. Laryngoscope. 2007 Aug;117(8):1457-62. — View Citation
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. — View Citation
Wormald PJ. Salvage frontal sinus surgery: the endoscopic modified Lothrop procedure. Laryngoscope. 2003 Feb;113(2):276-83. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frontal sinus stenosis | Evaluate the size of the frontal sinus outflow tract over one year after surgery | 1 year | |
Secondary | Number of postoperative debridements | Track the number of debridements required in the postoperative period | 1 year | |
Secondary | Need for further surgical intervention | Track if any further surgical procedures (in office or in operating room) that are required during postoperative period | 1 year | |
Secondary | Number of postoperative infections | Track the number of postoperative sinus infections, proven by culture, as well as the number of antibiotic courses required for treatment. | 1 year | |
Secondary | Lund Kennedy Endoscopy Score | Evaluation of the sinuses using nasal endoscopy and objective measurement using the validated Lund-Kennedy Endoscopy score | 1 year | |
Secondary | SNOT-22 score | Evaluation of patient quality of life using a validated questionnaire called the Sinonasal Outcome Test (SNOT) - 22. | 1 year |
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