Clinical trial · Interventional
Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure
Prospective Study for Improvement in Outcomes Following Draf III/Endoscopic Modified Lothrop Procedure Using a Porcine Intestinal Submucosal Graft
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Decided to do a different clinical trial opportunity.
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Sinusitis | — | UNRESOLVED | — |
| Frontal Sinusitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Porcine Intestinal submucosal xenograft | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control
- description
- 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.
- type
- EXPERIMENTAL
- label
- Cook Biodesign
- description
- 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.
- interventionNames
- Device: Porcine Intestinal submucosal xenograft
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (12)
- BACKGROUNDPleis JR, Lucas JW. Summary health statistics for U.S. adults: National Health Interview Survey, 2007. Vital Health Stat 10. 2009 May;(240):1-159. PMID 19645319
- BACKGROUNDNaidoo 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. PMID 22253224
- BACKGROUNDPynnonen 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. PMID 23900802
- BACKGROUNDAnderson 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. PMID 19554631
- BACKGROUNDWormald PJ. Salvage frontal sinus surgery: the endoscopic modified Lothrop procedure. Laryngoscope. 2003 Feb;113(2):276-83. doi: 10.1097/00005537-200302000-00015. PMID 12567082
- BACKGROUNDTran KN, Beule AG, Singal D, Wormald PJ. Frontal ostium restenosis after the endoscopic modified Lothrop procedure. Laryngoscope. 2007 Aug;117(8):1457-62. doi: 10.1097/MLG.0b013e31806865be. PMID 17585278
- BACKGROUNDYe 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. PMID 25079177
- BACKGROUNDAlQahtani 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.