Reconstruction of oral cavity and oropharyngeal defects using reinnervated flaps
Official title: Sensory Recovery and Functional Outcome After Reinnervated Profunda Artery Perforator Flap for Oral Cavity and Oropharyngeal Defect Reconstruction - Prospective Pilot Study
Run by University Hospital, Basel, Switzerland · NCT05997186 · Data updated 2026-11-12
This study is testing if a new type of surgery using special skin flaps can help patients who have had tumors removed from their mouth or throat regain their ability to swallow and speak better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | September 1, 2023 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | February 18, 2025 |
| Trial ID | NCT05997186 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with defects in the oral cavity or oropharynx who require reconstruction with a free reinnervated profunda artery perforator flap.
✕Probably not a fit
Patients under 18 years old or those with defects in areas other than the oral cavity or oropharynx may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the sensory recovery and functional outcomes in patients undergoing reconstruction of oral cavity and oropharyngeal defects using reinnervated profunda artery perforator (PAP) flaps. The research focuses on patients who have experienced significant functional deficits due to tumor resections, impacting their swallowing and speech abilities. By employing non-invasive testing methods, the study aims to assess the effectiveness of sensory recovery following the surgical intervention. The PAP flap is being explored as a viable alternative for patients with specific anatomical considerations, particularly those with thin lateral thigh thickness.
Why it matters
Potential benefit: If successful, this approach could significantly improve sensory recovery and quality of life for patients with oral cavity and oropharyngeal defects.
How similar studies have gone: Previous studies have shown success with reinnervated flaps in similar contexts, suggesting potential for positive outcomes with this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Patient with defect involving the oral cavity or oropharynx who undergo reconstruction with a free reinnervated profunda artery perforator flap Exclusion Criteria: * \<18 years old * Defect localizations other than the oral cavity or oropharynx * Not able to give informed consent * Inability to follow the procedures of the study, e.g., due to psychological disorders, dementia * Inability or contraindications to undergo the investigated intervention
Where it's running
-
University Hospital Basel
Basel, Switzerland Recruiting
Study contacts
- Principal investigator: Nicole E. Speck, Dr. med. — University Hospital, Basel, Switzerland
- Study coordinator: Nicole E. Speck, Dr. med.
- Email: nicoleedith.speck@usb.ch
- Phone: +41 61 328 41 64
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.