An observational study in Nasal Septal Perforation, sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz. Not yet recruiting at 3 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz · Observational
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.
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz is the lead sponsor of 76 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Nasal Septal Perforation Repair With an Autologous Oral Mucosal Graft
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.
Procedure: Nasal Septal Perforation Repair With an Autologous Oral Mucosal Graft
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.
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.
Time frame: 12 months
Percentage of Participants With at Least One Postoperative Complication
Percentage of participants experiencing at least one postoperative complication following nasal septal perforation repair with an autologous oral mucosal graft. Complications will be assessed during postoperative follow-up and recorded by type and anatomical site (nasal surgical site or oral donor site). Each participant will be counted once for the overall proportion, regardless of the number of complications experienced.
Time frame: From surgery through 12 months after surgery
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Nasal Septal Perforation
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz