Clinical trials: Free Flap Reconstruction, open to volunteers
Breast Reconstruction, Thrombosis, Venous
Bioimpedance Measurement of Abdominal Free Flaps During Arterial and Venous Weaning in Breast Reconstruction
As the occurrence of thrombosis in post surgery is rare, it seemed difficult to study only this one. This is why we decided to test the bioimpedance, temperature and green, red and infrared light absorption measurements of the…
- Conditions
- Breast Reconstruction, Thrombosis, Venous, Bioimpedance Measurement Capacity
- Trial name
- MONITRANS2 (NCT05710705)
- Testing
- portable prototype of bioimpedance measurement
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar
Study and Modeling of Perforator Flap Vascularization
The aim of reconstructive surgery is to restore physical integrity altered by trauma, congenital malformations or cancerous pathologies.
- Conditions
- Reconstructive Surgery Using Pedicled Perforating or Free Perforating Flaps, Pelvic Eschar, Traumatic Pathology of the Lower and/or Upper Limb
- Trial name
- EMoVaLP (NCT07084740)
- Testing
- PeriCam and PeriFlux measurements
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Breast Neoplasms, Ischemia-Reperfusion Injury
DIEP Flap Breast Reconstruction: Perioperative Biomarkers and Outcomes
Brief Summary This observational study will follow patients who undergo DIEP flap breast reconstruction to better understand a common surgical challenge called ischemia-reperfusion (I/R) injury.
- Conditions
- Breast Neoplasms, Ischemia-Reperfusion Injury, Postoperative Complications, Wound Healing
- Trial name
- NCT07263347
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Hubei Cancer Hospital
Reconstructive Surgical Procedures, Free Tissue Flaps
Energy Expenditure Assessment in Head and Neck Cancer Patients Treated With Free Flap Surgery
What is the purpose of this study? Patients with head and neck cancer who undergo surgery with free flap reconstruction often need careful nutritional support during recovery.
- Conditions
- Reconstructive Surgical Procedures, Free Tissue Flaps, Head and Neck Cancer, Perioperative Care
- Trial name
- NCT07759193
- Testing
- Indirect Calorimetry (Diagnostic Test)
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Mandibular Reconstruction, Segmental Mandibular Defects
Registry to Collect Data on Patients Undergoing Segmental Mandibular Defect Reconstruction Following Oral Squamous Cell Carcinoma Resection and Drugs-induced Osteonecrosis
Prospective will be collected in a minimum of 300 patients presenting with an acquired segmental mandibular defect ≥ 2 cm secondary to OSSC removal and drugs-induced osteonecrosis, and who require mandibular reconstruction.
- Trial name
- NCT04098146
- Testing
- Surgical Resection and Reconstruction
- Where
- 19 sites in United States, Germany and 6 more
- Volunteers
- 300 people
- Sponsor
- AO Innovation Translation Center
Scar Conditions and Fibrosis of Skin
Dermabrasion for Free Flap Aesthetic Enhancement
The purpose of this study is to evaluate the aesthetic benefit and safety of serial dermabrasion for free flap skin paddles and donor site scars in head and neck reconstruction.
- Trial name
- NCT07233200
- Testing
- Dermabrasion
- Volunteers
- 40 people
- Sponsor
- Milton S. Hershey Medical Center
Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm
Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery.
- Conditions
- Body Mass Index Greater Than or Equal to 30, Malignant Breast Neoplasm, Mammoplasty Patient, Obesity
- Trial name
- NCT04003038
- Testing
- Negative Pressure Wound Therapy, Wound Care Management
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- M.D. Anderson Cancer Center
Head and Neck Cancers
Biomedical Innovation for Facial Bone Reconstruction in Oncology: BIOFACE PASS a Medico-economic Study Describing the Standard Pathway of Patients Treated by Free Bone Flap
The purpose of this study is to describe the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers.
- Trial name
- BIOFACE PASS (NCT06771336)
- Testing
- Questionnaires
- Where
- 9 sites in France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Toulouse
Breast Cancer Surgery, Reconstruction Breast Surgery
Improvement in Breast Skin Sensibility After Breast Reconstruction: a Comparison of 3 Surgical Techniques
The goal of this clinical trial is to learn if nerve sutures in free flap breast reconstruction can optimize sensibility in the reconstructed breast in patients opting for DIEP flap breast reconstruction due to breast cancer or…
- Conditions
- Breast Cancer Surgery, Reconstruction Breast Surgery, Sensitization, DIEP Flap Breast Reconstruction
- Trial name
- S-DIEP (NCT06930378)
- Testing
- Nerve Suture
- Where
- Switzerland
- Volunteers
- 63 people
- Sponsor
- Patricia Esther Engels
Breast Cancer
Opioid Free Versus Opioid Based Anaesthesia for Free Flap Reconstruction Surgery of the Breast: A Phase III Multicentric Randomized Controlled Study.
This study will compare morphine consumption during the first 48 hours postoperatively between the OFA group and the CA control group.
- Trial name
- OFOBA (NCT05439005)
- Testing
- Dexmedetomidine
- Where
- 3 sites in France
- Volunteers
- 158 people
- Sponsor
- Institut Curie
Mandible Reconstruction
Assessment of Facial Symmetry Following Fibula Free Flap Fixated in a Prosthetically Favorable Position Versus the Inferior Border Position for Mandibular Reconstruction
The study aims to evaluate facial symmetry outcomes after mandibular reconstruction using fibula free flaps, comparing two fixation techniques: the prosthetically favorable position (alveolar level) and the conventional position…
- Trial name
- NCT06790628
- Testing
- Fibula free flap
- Where
- Egypt
- Volunteers
- 26 people
- Sponsor
- Cairo University
Breast Reconstruction, Breast Cancer
Optimizing Postoperative Recovery After Breast Reconstruction With Autologous Tissue (BestDIEP)
Women who have their breast reconstructed with autologous tissue seem to be more satisfied with their breast. However, autologous breast reconstruction entails a bigger operation, and the usage of more health care resources, than…
- Trial name
- BestDIEP (NCT05363189)
- Testing
- Venous augmentation, Traditional ERAS (enhanced recovery after surgery) protocol, Sahlgrenska recovery protocol
- Where
- Sweden
- Volunteers
- 380 people
- Sponsor
- Vastra Gotaland Region
Mandibular Reconstruction
Evaluation of an Universal Surgical Device for Mandibular Reconstruction.
Fibula free flap is the gold standard for mandibular reconstruction. The shape of the fibula requires osteotomy that can be performed with a custom surgical guide.
- Trial name
- FIBUMAND (NCT06238076)
- Testing
- Universal surgical device FIBUMAND
- Where
- France
- Volunteers
- 19 people
- Sponsor
- University Hospital, Toulouse
Tongue Squamous Cell Carcinoma, Mixed Reality
Resection and Defect Repair of Oral Cancer Aided by Mixed Reality Technology
The objective of this exploratory clinical trial is to apply Unreal Engine 5 (UE5)-based Mixed Reality (MR) technology to achieve real-time stereoscopic visualization of surgical planning, personalized free flap harvest and…
- Conditions
- Tongue Squamous Cell Carcinoma, Mixed Reality, Virtual Surgical Planning, Free Flap
- Trial name
- NCT07466810
- Testing
- Unreal Engine 5 (UE5)-based Mixed Reality (MR) Technology-assisted Resection of Oral Cancer and Defect Reconstruction, Virtual Surgical Guide Technology-assisted Resection of Oral Cancer and Defect Reconstruction
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Free Flap Reconstruction
Sufentanil Infusion vs Intravenous Methadone for Postoperative Analgesia Following Head and Neck Dissection With Free Flap or Rotational Reconstruction
The main purpose of this study is to determine which type of medication, sufentanil or methadone, is better at controlling pain during and, more importantly, after surgery in patients undergoing a head and neck dissection with…
- Trial name
- NCT06784999
- Testing
- sufentanil, methadone
- Where
- United States
- Volunteers
- 128 people
- Sponsor
- Indiana University
Head and Neck Cancer, Oral Cavity Cancer
Evaluation of the Benefit of a New Surgical Procedure According to IDEAL Recommendations for ORL Cancer Patients: the External Pudendal Flap Used as a New Free Flap for Oral Cavity/Oropharyngeal Reconstruction to Limit Donor Site Sequelae
This is a phase 1b, multicenter, non-randomized prospective study involving an innovation phase (IDEAL-1) followed by a prospective development phase (IDEAL-2A) designed to evaluate the safety and feasibility of…
- Conditions
- Head and Neck Cancer, Oral Cavity Cancer, Oropharynx Cancer
- Trial name
- LAMBEAU STEPA (NCT05757817)
- Testing
- Oropharyngeal or oral cavity reconstruction
- Where
- 4 sites in France
- Volunteers
- 40 people
- Sponsor
- Institut Claudius Regaud
Nose Cancer, Rhinectomy
Functional and Aesthetic Comparison of Surgical Nasal Reconstruction Versus Nasal Prosthesis (Epithesis) After Total or Subtotal Nasal Amputation
CERNAS is a prospective, multicenter, non-interventional study comparing the functional and aesthetic outcomes of two rehabilitation strategies after total or subtotal nasal amputation: surgical reconstruction (primarily…
- Trial name
- CERNAS (NCT07674030)
- Testing
- SCHNOS score
- Where
- 4 sites in France
- Volunteers
- 20 people
- Sponsor
- Hôpital NOVO
Head and Neck Cancer (H&N), Trauma Sequelae
Immunomonitoring of Circulating Immune Cells in Maxillofacial Surgery
The immune response following facial reconstruction may help predict healing time and the date of discharge after maxillofacial surgery.
- Conditions
- Head and Neck Cancer (H&N), Trauma Sequelae, Osteoradionecrosis of Jaws
- Trial name
- IMMUNOFACE (NCT07772063)
- Testing
- Treg
- Volunteers
- 60 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Oral Cancer, Postoperative Pain Management
Effect of Dezocine Versus Nalbuphine Combined With Sufentanil on Postoperative Analgesia, Complications, and Free Flap Survival in Patients Undergoing Oral Cancer Radical Surgery: A Randomized Controlled Clinical Trial.
Background: Oral cancer radical surgery often requires free flap reconstruction. Postoperative pain is severe, and traditional opioids like sufentanil have side effects and may adversely affect tumor biology.
- Conditions
- Oral Cancer, Postoperative Pain Management, Free Tissue Flaps, Mouth Neoplasms
- Trial name
- NCT07401641
- Testing
- Dezocine and Sufentanil combination, Nalbuphine and Sufentanil combination
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain
Effectiveness of Hydrogen Water Intervention on Acute Oral Inflammation, Oral Microbiota, and Pain Following Free Flap Reconstruction in Patients With Oral Cancer
This randomized, double-blind, parallel-group controlled trial evaluates the effectiveness of hydrogen water oral care on acute oral inflammation, oral microbiota, and pain in patients with oral cancer who have undergone free…
- Conditions
- Oral Squamous Cell Carcinoma (OSCC), Postoperative Pain, Postoperative Oral Mucositis, Free Flap Reconstruction
- Trial name
- NCT07306546
- Testing
- Hydrogen Water Oral Care, Water Oral Care
- Where
- Taiwan
- Volunteers
- 36 people
- Sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital