Clinical Research Directory

Oral Mucosal Grafting for Nasal Septal Perforation Repair

Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Summary

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.

Official title: Efficacy of Autologous Oral Mucosal Tissue as a Reconstructive Alternative in Nasal Septal Perforation Surgery

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