Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | Other | Oral cavity and oropharyngeal defect reconstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical reconstruction | Procedure | Surgical reconstruction with a free reinnervated profunda artery perforator flap |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
- Patient with defect involving the oral cavity or oropharynx who undergo reconstruction with a free reinnervated profunda artery perforator flap
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Nicole E. Speck, Dr. med. | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Recruiting | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38875869 | Derived | 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. |
Not provided
Not provided
Not provided
Prospective case series (pilot study)
Not provided
Not provided
Not provided
Not provided