Recruiting NCT05997186

Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction

No phase Interventional Oral Cavity Defect Oropharynx Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Surgical reconstruction.
Who it may be relevant to: Registry conditions: Oral Cavity Defect, Oropharynx Defect. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Switzerland
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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)

Interventions

Procedure Surgical reconstruction
Surgical reconstruction with a free reinnervated profunda artery perforator flap

Primary outcome measures

Change in Semmes-Weinstein monofilament testing [Time frame: 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]
Change in temperature perception [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Switzerland · 1 center

University Hospital Basel — Basel

Publications

Speck NE, Haumer A, Pfister P, Muller L, Gahl B, Burger M, Largo RD, Schaefer DJ, Ismail T. Neurotized profunda artery perforator flap for subtotal tongue reconstruction - Prospective case series. J Plast Reconstr Aesthet Surg. 2024 Aug;95:35-42. doi: 10.1016/j.bjps.2024.05.028. Epub 2024 May 31. PMID 38875869

Identifiers

NCT: NCT05997186 · 2023-00938; mu23schaefer

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗