NCT Number: NCT05997186
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Basel, 4031, Switzerland
Location status: Recruiting
Britta Gahl, PhD
SUB_INVESTIGATOR
Dirk J Schaefer, Prof. Dr.
CONTACT
Dirk J. Schaefer, Prof. Dr.
SUB_INVESTIGATOR
Laurent Muller, PD Dr.
SUB_INVESTIGATOR
Nicole E. Speck, Dr. med.
CONTACT
Nicole E. Speck, Dr. med.
PRINCIPAL_INVESTIGATOR
Tarek Ismail, PD Dr. med.
SUB_INVESTIGATOR
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)
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical reconstruction with a free reinnervated profunda artery perforator flap
Time frame: before surgery and 3, 6 and 12 month after surgery
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".
Time frame: before surgery and 3, 6 and 12 month after surgery
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"
Time frame: before surgery and 3, 6 and 12 month after surgery
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.
Time frame: before surgery and 3, 6 and 12 month after surgery
Pain perception will be assessed with a 27-gauge needle.
Contact information is provided by the study sponsor or research team.
Dirk J. Schaefer, Prof. Dr.
CONTACT
Nicole E. Speck, Dr. med.
CONTACT
University Hospital, Basel, Switzerland
Other
Sensory Recovery and Functional Outcome After Reinnervated Profunda Artery Perforator Flap for Oral Cavity and Oropharyngeal Defect Reconstruction - Prospective Pilot Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
