Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction

February 17, 2025 updated by: University Hospital, Basel, Switzerland

Sensory Recovery and Functional Outcome After Reinnervated Profunda Artery Perforator Flap for Oral Cavity and Oropharyngeal Defect Reconstruction - Prospective Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital Basel
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicole E. Speck, Dr. med.
        • Sub-Investigator:
          • Tarek Ismail, PD Dr. med.
        • Sub-Investigator:
          • Dirk J. Schaefer, Prof. Dr.
        • Sub-Investigator:
          • Laurent Muller, PD Dr.
        • Sub-Investigator:
          • Britta Gahl, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Surgery
Oral cavity and oropharyngeal defect reconstruction
Procedure: Surgical reconstruction
Surgical reconstruction with a free reinnervated profunda artery perforator flap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Semmes-Weinstein monofilament testing
Time Frame: before surgery and 3, 6 and 12 month after surgery

The Semmes-Weinstein Monofilament test is a sensory assessment tool. This assessment tool consists of a set of monofilaments that vary in thickness and diameter, the gradient forces of these monofilaments ranges from .086 gm to 448gm. These monofilaments are used to map out sensory loss or recovery.

Semmes-Weinstein monofilament testing will be performed at the tip (distal 1 cm) and the dorsum of the reconstructed flap/neo-tongue. Semmes-Weinstein monofilament testing will also be performed in the profunda artery perforator flap territory on the ipsilateral and contralateral thigh. For this purpose, the investigators will use the "Baseline FoldUp Monofilament Evaluator Set with Case".
before surgery and 3, 6 and 12 month after surgery
Change in two-point discrimination test
Time Frame: before surgery and 3, 6 and 12 month after surgery
The two-point discrimination test is used to assess if the patient is able to identify two close points on a small area of skin, and how fine the ability to discriminate this are. It will be measured using "Dellon Disk Criminator"
before surgery and 3, 6 and 12 month after surgery
Change in temperature perception
Time Frame: before surgery and 3, 6 and 12 month after surgery
Hot (50 degrees Celsius) and cold (4 degrees Celsius) temperature perception will be assessed by use of a small test tube filled with water at the appropriate temperatures.
before surgery and 3, 6 and 12 month after surgery
Change in pain perception
Time Frame: before surgery and 3, 6 and 12 month after surgery
Pain perception will be assessed with a 27-gauge needle.
before surgery and 3, 6 and 12 month after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Nicole E. Speck, Dr. med., University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 10, 2023

First Submitted That Met QC Criteria

August 10, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 17, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-00938; mu23schaefer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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