NCT05997186

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Sep 2023May 2027

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
14 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

3.7 years

First QC Date

August 10, 2023

Last Update Submit

February 17, 2025

Conditions

Oral Cavity DefectOropharynx Defect

Keywords

reconstruction with a free reinnervated profunda artery perforator flapsensory recovery

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

Surgery

OTHER

Oral cavity and oropharyngeal defect reconstruction

Procedure: Surgical reconstruction

Interventions

Surgical reconstructionPROCEDURE

Surgical reconstruction with a free reinnervated profunda artery perforator flap

Surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

Related Publications (1)

  • 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: 38875869DERIVED

Study Officials

  • Nicole E. Speck, Dr. med.

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole E. Speck, Dr. med.

CONTACT

+41 61 328 41 64nicoleedith.speck@usb.ch

Dirk J. Schaefer, Prof. Dr.

CONTACT

dirk.schaefer@usb.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective case series (pilot study)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

February 18, 2025

Record last verified: 2025-02

Locations

CH(1)