Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure
|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: NCT02981017|
Recruitment Status : Withdrawn (Decided to do a different clinical trial opportunity.)
First Posted : December 2, 2016
Last Update Posted : October 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Chronic Sinusitis Frontal Sinusitis||Device: Porcine Intestinal submucosal xenograft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Study for Improvement in Outcomes Following Draf III/Endoscopic Modified Lothrop Procedure Using a Porcine Intestinal Submucosal Graft|
|Actual Study Start Date :||November 1, 2016|
|Actual Primary Completion Date :||December 28, 2019|
|Actual Study Completion Date :||December 28, 2019|
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
- Frontal sinus stenosis [ Time Frame: 1 year ]Evaluate the size of the frontal sinus outflow tract over one year after surgery
- 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.
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
|United States, California|
|University of California Los Angeles|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Jeffrey D Suh, MD||University of California Los Angeles, Department of Head and Neck Surgery|