Clinical trial · Interventional
Evaluation of the Interest of the Neurorrhaphy in Resensitizing Free Flaps
Evaluation of the Interest of the Neurorrhaphy in the Resensitisation of Free Flaps in Maxillofacial Reconstructive Surgery. Randomized Prospective Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The surgical procedure consists in removing a tumor of the oral cavity and then repairing the oral defect by the use of a free flap. A free flap is tissue composed of skin and aponeurosis taken from the thigh or forearm, or tissue composed of bone taken from the leg to fill in tissue loss. This tissue is vascularized by a vein and an artery that are removed with the flap to ensure its survival. Investigator would also like to harvest the nerve involved in the sensitivity of the skin flap to suture it to a nerve which will be located near the reconstructed area, and this to enhance sensitivity of the reconstructed oral cavity. Thanks to this, investigator also wish to highlight that this resensitization would improve the patient's quality of life particularly regarding his major oral functions (swallowing, phonation, sensation of cold and hot felt, chewing). Investigator therefore seek to demonstrate that suturing the nerve will give to the patient the ability back to feel tactile and thermal sensations This is the purpose of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Reconstructive Surgery After Carcinological Excision | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| neurorrhaphy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Resensitized group
- description
- Patients with resensitized free flap by neurorrhaphy
- interventionNames
- Procedure: neurorrhaphy
- type
- EXPERIMENTAL
- label
- Non Resensitized group
- description
- Patients without resensitized free flap by neurorrhaphy.
- interventionNames
- Procedure: neurorrhaphy
Primary outcomes (3)
- measure
- Epicritic sensitivity measurement
- timeFrame
- Before intervention (at day 1).
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- Patient eligible for reconstructive surgery after carcinological excision following a decision taken in a multidisciplinary consultation, and for whom the envisaged oral defect concerns either the soft tissues of the oral cavity and oropharynx, or the mandibular bone * Scheduled post-operative radiotherapy * Coverage by the Social Security system * Capacity to provide informed consent Exclusion Criteria: * Post-traumatic substance loss (ballistic autolysis) * Surgical or anesthetic contraindication (physiological age, other proposed therapeutic options) * Pregnant or breastfeeding woman * Subject incapable of full age or deprived of liberty * Indication for chemotherapy with highly neurotoxic agents * Inability to complete questionnaires or express feelings during the examination * Any situation judged by the investigator as a contraindication to neurorrhaphy
References
Publications (0)
Data not yet available