Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Skin Neoplasms

Skin Diseases

Patients with facial cancer or disfigurement who require reconstructive surgery will be offered participation in this study.

3D photography is available at our unit department of clinical photography. Photos will be taken and the associated NHS software (Canfield Imaging scientific, inc) used to sit down with the patients and model their reconstruction, thereby reducing anxiety and improving awareness of their treatment plan.

3D photography and computer modelling

Prateush Singh, MBBChir

prateush singh, mbbchir

The aim of this study is to improve patient satisfaction and outcomes in facial reconstructive surgery by using 3D clinical photography and computer modelling to help illustrate and plan the patients' reconstructive journey.

It will be conducted at the Royal Free Hospital department of Plastic and Reconstructive Surgery, where patients with facial deformities or suspected diagnoses of skin cancer will be referred from their GP or dermatology services. As is routine standard of care, they will be reviewed in outpatient settings and the next management steps initiated. Our study will introduce compulsory 2D and 3D photography and patient satisfaction questionnaires. The photographs will be used to sit down with the participant and illustrate the intended surgical reconstruction, keeping them up to date and fully informed of the surgical plan. The questionnaire, FACE-Q, already validated for facial skin cancer surgery and reconstruction, will be used to assess their satisfaction at each stage of their reconstructive journey.

The results of the study will benefit each participant and illustrate an improvement in satisfaction so that such 3D photography, surgical planning with computer models produced by these 3D images will become a routine part of future patients with facial disfigurement or cancer requiring reconstruction.

This study will form part of a PhD academic qualification at UCL for one of the research registrars.

Setting: Royal Free Hospital, London. Single site. Study Population: Adult patients aged over 18 presenting with;

• Facial defects resulting from cancer or trauma

Consent from the patients will be obtained as soon as possible, during outpatient consultation.

Study design: observational case series, feasibility study. As this is an open observational study, there will be no randomization. As numbers of participant's attending with facial skin cancer defects requiring reconstruction is small, there will not be any sampling.

Expected number of participants: 10. Number determined after discussion with Chief Investigators as adequate to determine feasibility or incorporating 3D photography, computer modelling and questionnaires to improve satisfaction. Statistical input from supervisor and chief investigator, Professor Eva Krumhuber, department of experimental psychology.

Duration of study: 12 months Methodology: Clinic Consultation Patients will be referred to our craniofacial clinic with either pre-defect or pre-biopsy lesions suspicious of being skin malignancies, or following biopsy or defect resulting from excision, trauma or Mohs surgery.

If the lesion is suspicious for cancer but has not been diagnosed, this is discussed with the patient and a biopsy booked. During the consultation the patient is sent for clinical 2D and 3D photography in the Royal Free Hospital Department of Clinical Photography.

If the patient presents to clinic with the defect, multiple pre-defect 2D photographs are requested from the patient and stored on the hospital protected plastic surgery department shared drive.

Photography All patients will undergo outpatient 2D and 3D photography in the Royal Free Hospital Department of Clinical Photography.

Computer modelling All images will be processed using the Vectra XT software from Canfield Imaging Scientific, inc. used at the Royal Free Hospital Department of Clinical Photography. From this, 3D images can be layered, accurate calculations made and the size of defects accurately measured and templated. 3D models can be manipulated to illustrate each stage of the reconstruction.

Treatment modality Treatment modalities will involve standard of care surgical management, pre-assessment and post-operative care. This includes skin cancer and craniofacial MDT multidisciplinary team discussions to plan and decide treatment. This will all take place at Royal Free Hospital, London.

Patient questionnaires Patients will be asked to complete FACE-Q questionnaires at each consultation and after each stage of their reconstruction at initial consultation, 6 weeks post op, 3 months, 6 months and 1 year follow up.

FACE-Q is a validated questionnaire patient reported outcome measure including measures for satisfaction with facial appearance, health-related quality of life, recovery, early life impact, adverse effects and satisfaction with process of care (Klassen et al. 2010).

Follow up For patient who have undergone biopsy, they will be reviewed in the plastic surgery dressings clinic 1 week post op to review the wound; their histology will be discussed in the skin MDT 4-6 weeks later and the patient informed in a consultation of the results.

If further excision or reconstruction is required, the patient will undergo the required imaging and computer modelling and undergo the operative procedure. They will then be reviewed a week later in our dressings clinic and at the next stage of their procedure in 3-4 weeks if staged reconstruction is required. After the final reconstruction, they will be reviewed in outpatient clinic at 6 weeks, 3 months, 6 months and 1 year follow up.

Data collection and storage:

Data will be collected from source (medical notes, questionnaires, and images), and collected on a case record form (CRF) and then transferred to an electronic database. The master database will be recorded by code and will hence be anonymized. Some parts of the medical records and the data collected for the study will be looked at by authorised persons such as the members of the research team, regulatory authorities, the Trust, and the sponsors of this study. They may also be looked at by authorised people to check that the study is being carried out correctly. All will have a duty of confidentiality.

Anonymised extracts of the database may be transferred securely to UCL for analysis. Anonymised images may be shared with researchers in the department of surgery and interventional sciences at UCL.

In some circumstances the data in an anonymous form may be used for preparation of the trial report, and for submission to Government agencies as part of the procedures.

The data may be required for further studies, in which case further Research Ethics Committee approval will be sought. Access to personal data is strictly controlled and limited to authorised personnel only.

Personal data will be stored on paper forms held in a secure, locked office accessible to authorised personnel only. At the end of the study, personal data in paper form (completed Case Record Forms) will be archived securely.

The dataset will be used for the sole purpose set out in this protocol. Anonymised raw data will not be shared with any other organisation or named individual.

In the study, data will be collected from patients in accordance with the patient consent form, patient information sheet and as described in this protocol.

The data will be appropriately maintained by authorised members of the research team for statistical analysis.

The Chief Investigator will nominate an individual to process, store and dispose of study data in accordance with all applicable legal and regulatory requirements, including the Data Protection Act 1998 and any amendments thereto.

Non anonymised data will not be transferred to any party not identified in the protocol and will not be processed and/or transferred other than in accordance with the patients' consent.

facial skin cancers must be excised- this tissue will be sent to the Royal Free Hospital department of histopathology for review as is standard of care for these patients.

Computer Modelling to Plan Surgical Reconstruction

Computer Modelling Using 2D and 3D Photographs of Patients Faces to Improve Surgical Reconstructive Planning in a Clinical Case Series of Patients With Facial Defects and Improve Patient Satisfaction

no data will be shared with researchers outside of the research team

using the validated FACE-Q questionnaire for patients with skin cancer

Royal Free Hospital NHS Foundation Trust

NIHR Academic Clinical Fellow

Wounds and Injuries

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Nervous System Diseases

Musculoskeletal Diseases

Nutritional and Metabolic Diseases

Eye Diseases

Rare Diseases

Syndrome

Fractures, Bone

Fetal Growth Retardation

Mandibular Fractures

Fibrous Dysplasia of Bone

Neuroma

Oculocerebrorenal Syndrome

Osteoma

Mandibulofacial Dysostosis

Goldenhar Syndrome

Dysostoses

Disease Attributes

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Osteochondrodysplasias

Mucopolysaccharidosis IV

Bone Diseases

Bone Diseases, Developmental

Jaw Fractures

Maxillofacial Injuries

Facial Injuries

Craniocerebral Trauma

Trauma, Nervous System

Skull Fractures

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Craniofacial Dysostosis

Congenital Abnormalities

Craniofacial Abnormalities

Musculoskeletal Abnormalities

Coloboma

Eye Diseases, Hereditary

Fibrous Dysplasia

Miller Syndrome

Hemifacial Microsomia

Treacher Collins Syndrome

Craniofacial Microsomia

Goldenhar Disease

Oculo-auriculo-vertebral Spectrum

Mucopolysaccharidosis Type IV

Crouzon Syndrome

Pharmaceutical Solutions

All Drugs and Chemicals

Gastrointestinal Agents

Cimetidine

Patients undergoing surgical procedures for facial reconstruction for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.

Patients undergoing surgical procedures for mandibular reconstruction, including TMJ, for whom Biomet Microfixation titanium plates (or Ti mini plates) were utilized for the repair.

Patients undergoing surgical procedures for midface reconstruction using custom-made prostheses manufactured on PEEK material.

The Facial Plating System provides a comprehensive titanium fixation solution for maxillofacial surgery procedures. More than twenty-five different plating options in two systems, the 1.5 mm and 2.0 mm with a variety of instruments, and high torque screws, including meshes, are part of this system. Plates and screws are made of commercially pure titanium per ASTM F-67, Titanium 6Al 4V Alloy per ASTM F-136.

Titanium Facial Plates

The Mandibular Plating System provides a comprehensive titanium fixation solution for mandibular surgical procedures. Several plating options, a variety of instruments, and high torque screws with various plate shapes are part of this system.

Plates in the Mandibular Plating System have profiles of various thicknesses. Screws are available in self-tapping, locking and non-locking varieties, and in various sizes between 2.0 mm and 2.3 mm in diameter, and 5 mm to 18 mm in length.

Titanium Mandibular Plates

The Add-On Condyle is intended to be implanted in the human jaw to replace the mandibular condyle to functionally reconstruct the temporomandibular joint on a temporary basis for patients undergoing ablative tumor surgery requiring the removal of the native mandibular condyle. This device is not for permanent implantation, traumatic injuries, or for treatment of temporomandibular joint disease.

Add-on Condyle

The HTR-PEKK implants are fabricated from polyether-ketone-ketone (PEKK) via selective laser sintering (SLS), a 3D manufacturing technique. The laser sintering machine builds the implant in layers as dictated from a stereolithographic (STL) file of the approved implant. The HTR-PEKK implants are designed individually for each patient to replace bony voids in the facial anatomy using a patient's own CT imaging data. The implant is made to fill an existing or planned void (where appropriate) using computer-aided design technology for anatomy enhancement, correction of trauma injuries, and/or to correct congenital defects in the craniofacial bone.

HTR-PEKK

Mark Sun, PhD

This study will address medical devices manufactured by Biomet Microfixation (d.b.a. Zimmer Biomet) designed for fixation and stabilization of the facial and mandibular skeleton.

The subject devices are:

* plates, screws, and primary instruments from the Biomet Microfixation Facial Plating System, including plates to be specifically used in orthognathic procedures
* plates, screws and primary instruments for the Mandibular Plating System, including and a device intended to temporarily restore the functionality of the temporomandibular joint for patients whose natural condyle has to be resected, subsequent to a tumor ablation ("Add-On Condyle") Additionally, a third device intended for the replacement of bony voids in the facial skeleton will be evaluated in this trial (HTR-PEKK- facial application).

A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.

Clinical Evaluation of Biomet Microfixation Devices Used in Facial & Mandibular Surgical Procedures. Facial Plating System, HTR PEKK (Midface) and Mandibular Plates: A Post Market Clinical Follow-up Study

This data will support regulatory approval on the subject device. Data from this study will not be made available to other researchers

Frequency and incidence of clinical and radiological adverse events related to the implantation of the subject device leading to removal

Clinical and/or pathological assessment of implant allergic reactions leading to removal of the device in the first 2 years post implantation

Zimmer Biomet

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Computer Modelling to Plan Surgical Reconstruction	NCT04968704	Surgery Cancer of Skin	3D photography ...	18 Years -	Royal Free Hospital NHS Foundation Trust
Computer Modelling to Plan Surgical Reconstruction	NCT04968704	Surgery Cancer of Skin	3D photography ...	18 Years -	Royal Free Hospital NHS Foundation Trust
A Post Market Clinical Follow-up Study on Biomet Microfixation HTR PEKK (Midface), Facial & Mandibular Plates.	NCT04931056	Tumor Facial Fracture Mandibular Frac... Fibrous Dysplas... Osteoma of Mand... Neuroma Cleft Face Hemifacial Micr... Treacher Collin... Miller Syndrome Nager Syndrome	Titanium Facial... Titanium Mandib... Add-on Condyle HTR-PEKK	18 Years - 100 Years	Zimmer Biomet

Spots Global Cancer Trial Database for facial reconstruction