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Oral Cavity DefectNCT05997186

Reinnervated PAP Flap for Oral Cavity and Oropharyngeal Defect Reconstruction

A study testing Surgical reconstruction in people with Oral Cavity Defect and Oropharynx Defect, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Cavity Defect, Oropharynx Defect
What is being tested?
Surgical reconstruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSwitzerland
Study dates
1 Sep 2023to May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patient with defect involving the oral cavity or oropharynx who undergo reconstruction with a free reinnervated profunda artery perforator flap

Who cannot join

  • <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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicole E. Speck, Dr. med. contact

+41 61 328 41 64

nicoleedith.speck@usb.ch

Dirk J. Schaefer, Prof. Dr. contact

dirk.schaefer@usb.ch

Switzerland1 site, 1 recruiting

  • University Hospital Basel

    Basel, 4031

    Nicole E. Speck, Dr. med., nicoleedith.speck@usb.ch

    Dirk J Schaefer, Prof. Dr., dirk.schaefer@usb.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.

Read the 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)

Being tested
Surgical reconstruction
Keywords
reconstruction with a free reinnervated profunda artery perforator flap, sensory recovery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surgical reconstructionProcedure or surgery

    Surgical reconstruction with a free reinnervated profunda artery perforator flap

Study groups in NCT05997186
Study groupRoleWhat they receive
SurgeryOtherOral cavity and oropharyngeal defect reconstruction
Receives: Procedure: Surgical reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: before surgery and 3, 6 and 12 month after surgery

  2. 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"

    Measured: before surgery and 3, 6 and 12 month after surgery

  3. 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.

    Measured: before surgery and 3, 6 and 12 month after surgery

  4. Change in pain perception

    Pain perception will be assessed with a 27-gauge needle.

    Measured: before surgery and 3, 6 and 12 month after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2023
  2. Study start1 Sep 2023
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective case series (pilot study)
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05997186
Sponsor's protocol ID
2023-00938; mu23schaefer
Other IDs
2023
Status last verified
Feb 2025
First submitted
10 Aug 2023
Last updated
18 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 38875869

Questions about this trial

What is this clinical trial studying?

A study testing Surgical reconstruction in people with Oral Cavity Defect and Oropharynx Defect, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicole E. Speck, Dr. med. (+41 61 328 41 64, nicoleedith.speck@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Semmes-Weinstein monofilament testing (time frame: before surgery and 3, 6 and 12 month after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05997186, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.

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