ClinicalTrials.Veeva

Menu

Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction

University Hospital Basel logo

University Hospital Basel

Status

Enrolling

Conditions

Oral Cavity Defect
Oropharynx Defect

Treatments

Procedure: Surgical reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT05997186
2023-00938 mu23schaefer;

Details and patient eligibility

About

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.

Full 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)

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Surgery
Other group
Description:
Oral cavity and oropharyngeal defect reconstruction
Treatment:
Procedure: Surgical reconstruction

Trial contacts and locations

1

Loading...

Central trial contact

Dirk J. Schaefer, Prof. Dr.; Nicole E. Speck, Dr. med.

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems