NCT07902856|Not Yet Recruiting
Oral Mucosal Grafting for Nasal Septal Perforation Repair
Efficacy of Autologous Oral Mucosal Tissue as a Reconstructive Alternative in Nasal Septal Perforation Surgery
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Efficacy of Autologous Oral Mucosal Tissue as a Reconstructive Alternative in Nasal Septal Perforation Surgery
Sponsor study identifier
observational
46
1 country
3
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study will assess how often a hole in the nasal septum (the wall separating the two sides of the nose), closes completely after surgical repair using tissue taken from the lining of the patient's own mouth. The study will include 46 adults with nasal septal perforations measuring 1.5 cm or less at three hospitals in Spain. Surgery will be performed as part of usual clinical care. Participants will be assessed before surgery and at 1, 3, 6, and 12 months after surgery. The main outcome is complete closure of the perforation at 12 months, assessed by examining the inside of the nose with a small camera. Researchers will also assess nasal symptoms, quality of life, pain in the nose and mouth, and complications. Swab samples will be collected from the nose and mouth before surgery and from the nose during follow-up. These samples will help researchers study changes in the bacteria present in the nose and whether bacteria found in the mouth before surgery are detected in the nose after repair. Researchers will also explore whether outcomes differ according to whether the tissue graft was immersed in chlorhexidine, an antiseptic, during surgery. This decision is made by the surgeon as part of usual care, independently of study participation. The study does not assign participants to treatments.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 23, 2026
Actual (reported)October 29, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Percentage of Participants With Complete Nasal Septal Perforation Closure
Percentage of participants with complete closure of the nasal septal perforation, confirmed by nasal endoscopic examination 12 months after repair with an autologous oral mucosal graft. Closure is assessed as a binary outcome (complete closure: yes/no). Complete closure is defined as the absence of a residual perforation.
12 months
Percentage of Participants With at Least One Postoperative Complication
From surgery through 12 months after surgery
Patients undergoing nasal septal perforation repair with an autologous oral mucosal graft immersed in chlorhexidine during surgery. Graft immersion is determined by the treating surgeon as part of routine clinical care, independently of study participation. Patients are classified in this cohort according to the exposure received; the study does not assign treatment.
Patients undergoing nasal septal perforation repair with an autologous oral mucosal graft without intraoperative immersion in chlorhexidine. The decision not to immerse the graft is made by the treating surgeon as part of routine clinical care, independently of study participation. Patients are classified in this cohort according to the exposure received; the study does not assign treatment.
Surgical repair of a nasal septal perforation measuring 1.5 cm or less using a free graft harvested from the patient's own oral mucosa. The graft is placed at the septal defect to promote closure. Surgery is performed as part of routine clinical care. The indication for surgery and surgical management are determined by the treating surgeon independently of study participation.
Adults aged 18 years or older with a nasal septal perforation measuring 1.5 cm or less and no previous surgical repair attempt, who are candidates for repair with an autologous oral mucosal graft as part of routine clinical care. Participants will be recruited from the otorhinolaryngology outpatient clinics of Hospital Universitario Fundación Jiménez Díaz, Hospital General de Villalba, and Hospital Universitario Infanta Elena in Spain. Eligible patients will be invited to participate and will provide written informed consent.
Hospital General de Villalba
Madrid, Madrid, 28040, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
Santiago Horcajada M, Sanchez Barrueco A, Aragones Sanzen-Baker W, Diaz Tapia G, Moreno Luna R, Villacampa Auba F, Cenjor Espanol C, Villacampa Auba JM. Efficacy of Oral Mucosal Grafting for Nasal, Septal, and Sinonasal Reconstruction: A Systematic Review of the Literature. Life (Basel). 2025 Aug 13;15(8):1281. doi: 10.3390/life15081281.
First Submitted
October 23, 2026
First Posted
October 29, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
October 2028
EstimatedContact the study team to confirm eligibility.
Hospital Universitario Infanta Elena
Madrid, Madrid, Spain
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 29, 2026
Record last verified: 2026-10
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