Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction

Study Overview
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Brief Summary
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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
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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)

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

Conditions
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Oral Cavity Defect, Oropharynx Defect

Intervention / Treatment
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* Procedure: Surgical reconstruction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective case series (pilot study)
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Semmes-Weinstein monofilament testing | 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 | 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 | 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 | Pain perception will be assessed with a 27-gauge needle. | before surgery and 3, 6 and 12 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reconstruction with a free reinnervated profunda artery perforator flap, sensory recovery