Reconstruction of oral cavity and oropharyngeal defects using reinnervated flaps
Sensory Recovery and Functional Outcome After Reinnervated Profunda Artery Perforator Flap for Oral Cavity and Oropharyngeal Defect Reconstruction - Prospective Pilot Study
NA · University Hospital, Basel, Switzerland · NCT05997186
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel) |
| Trial ID | NCT05997186 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous studies have shown success with reinnervated flaps in similar contexts, suggesting potential for positive outcomes with this novel approach.
Eligibility criteria
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 this trial is running
Basel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Cavity Defect, Oropharynx Defect, reconstruction with a free reinnervated profunda artery perforator flap, sensory recovery