Nasal Septal PerforationNCT07902856
Oral Mucosal Grafting for Nasal Septal Perforation Repair
An observational study of Nasal Septal Perforation, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 3 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Septal Perforation
- What is being tested?
- Nasal Septal Perforation Repair With an Autologous Oral Mucosal Graft
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 46 participants
- Where
- 3 sitesSpain
- Study dates
- Nov 2026to Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Age 18 years or older.
- Nasal septal perforation measuring 1.5 cm or less.
- No previous surgical attempt to repair the septal perforation.
- Clinical indication for surgical closure of the septal perforation.
- Perforation of iatrogenic, idiopathic, traumatic, or controlled inflammatory origin.
- Willingness to participate and provision of written informed consent.
Who cannot join
- Recent intranasal exposure to toxic substances (less than 1 year).
- Active systemic autoimmune or connective tissue disease with nasal involvement.
- Active infection involving the nose.
- Active periodontal disease.
- Previous surgical repair of the septal perforation.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites
Hospital General de Villalba
Madrid, Madrid, 28040
Álvaro Sánchez Barrueco, Medicine, +34606731826, alvaro.sanchez@quironsalud.es
Álvaro Sánchez Barrueco, Medicine
Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid
José Miguel Villacampa Aubá, Medicine, +34679890270, jmv@fjd.es
José Miguel Villacampa Aubá, Medicine
Hospital Universitario Infanta Elena
Madrid, Madrid
Sara Zaldívar Saíz-Maza, Medicine, +34669604981, sara.zaldivar@quironsalud.es
Sara Zaldívar Saíz-Maza, Medicine
About this study
Official title: Efficacy of Autologous Oral Mucosal Tissue as a Reconstructive Alternative in Nasal Septal Perforation Surgery
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.
Read more
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.
- Conditions
- Nasal Septal Perforation
- Being tested
- Nasal Septal Perforation Repair With an Autologous Oral Mucosal Graft
- Keywords
- Oral Mucosal Graft, Autologous Graft, Septal Perforation Repair, Nasal Microbiota, Oral Microbiota, Chlorhexidine
- Medical subject headings
- Nasal Septal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal Septal Perforation Repair With an Autologous Oral Mucosal GraftProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Mucosal Graft With Chlorhexidine Immersion | 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. Receives: Procedure: Nasal Septal Perforation Repair With an Autologous Oral Mucosal Graft | |
| Oral Mucosal Graft Without Chlorhexidine Immersion | 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. Receives: Procedure: Nasal Septal Perforation Repair With an Autologous Oral Mucosal Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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.
Measured: From surgery through 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal Septal PerforationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902856
- Sponsor's protocol ID
- MUCOSA2026
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40868929
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Autologous Oral Mucosal Tissue as a Reconstructive Alternative in Nasal Septal Perforation Surgery
- ClinicalTrials.gov ID
- NCT07902856
- Acronym / sponsor ID
- MUCOSA2026
- Conditions
- Nasal Septal Perforation
- Keywords
- Oral Mucosal Graft, Autologous Graft, Septal Perforation Repair, Nasal Microbiota, Oral Microbiota, Chlorhexidine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 29 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Mucosal Graft With Chlorhexidine Immersion | – | Procedure: Nasal Septal Perforation Repair With an Autologous Oral Mucosal GraftPatients 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. |
| Oral Mucosal Graft Without Chlorhexidine Immersion | – | Procedure: Nasal Septal Perforation Repair With an Autologous Oral Mucosal GraftPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Nasal septal perforation measuring 1.5 cm or less.
- No previous surgical attempt to repair the septal perforation.
- Clinical indication for surgical closure of the septal perforation.
- Perforation of iatrogenic, idiopathic, traumatic, or controlled inflammatory origin.
Key exclusion criteria (5 listed)
- Recent intranasal exposure to toxic substances (less than 1 year).
- Active systemic autoimmune or connective tissue disease with nasal involvement.
- Active infection involving the nose.
- Active periodontal disease.
- Previous surgical repair of the septal perforation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal Septal Perforation Repair With an Autologous Oral Mucosal GraftSurgical 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. | Procedure or surgery | Oral Mucosal Graft With Chlorhexidine Immersion, Oral Mucosal Graft Without Chlorhexidine Immersion |
Primary outcome
Percentage of Participants With Complete Nasal Septal Perforation Closure
Time frame: 12 months
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.
1 secondary outcome
Percentage of Participants With at Least One Postoperative Complication
Time frame: From surgery through 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Results publication: PubMed 40868929Santiago 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Septal Perforation, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marta Santiago Horcajada, Medicine (+34 680763016, marta.santiago1999@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Complete Nasal Septal Perforation Closure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07902856, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.