Clinical trial NCT05997186: Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction
Official title: Sensory Recovery and Functional Outcome After Reinnervated Profunda Artery Perforator Flap for Oral Cavity and Oropharyngeal Defect Reconstruction - Prospective Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Cavity Defect
Oropharynx Defect
Keywords: reconstruction with a free reinnervated profunda artery perforator flap
sensory recovery
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective case series (pilot study)
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate sensory recovery and functional outcomes following oral cavity and oropharyngeal defect reconstruction with reinnervated PAP (profunda artery perforator) flaps.

Detailed description: Tumor resections involving the oral cavity or oropharynx cause significant functional deficits in swallowing and speech and subsequently impair the patients' quality of life. The anterolateral thigh (ALT) flap is widely regarded as a workhorse flap to reconstruct such defects. Previous studies assessing recovery of reinnervated ALT flaps reported superior sensory recovery, improved swallow function, and improved overall patient satisfaction in patients with reinnervated flaps compared with patients who received ALT flap reconstruction without sensory reinnervation. Recently, the profunda artery perforator (PAP) flap has been proposed as an alternative donor site in malnourished patients with thin lateral thigh thickness. However, reinnervation of PAP flaps has not been described. The study assesses sensory recovery after defect reconstruction with the reinnervated profunda artery perforator flap using already approved, non-invasive testing (Semmes-Weinstein monofilament testing, two-point discrimination, temperature, pain perception)

Eligibility 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

Primary outcomes:
measure: Change in Semmes-Weinstein monofilament testing
timeFrame: before surgery and 3, 6 and 12 month after surgery
measure: Change in two-point discrimination test
timeFrame: before surgery and 3, 6 and 12 month after surgery
measure: Change in temperature perception
timeFrame: before surgery and 3, 6 and 12 month after surgery
measure: Change in pain perception
timeFrame: before surgery and 3, 6 and 12 month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Nicole E. Speck, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: