A Phase 1/2, Single-Center, Open-Label, Single-Arm Safety, Tolerability, and Efficacy Study of an Auricle and Wedge Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
NCT06225336 — Microtia
Status: Enrolling by invitation
http://inclinicaltrials.com/microtia/NCT06225336/
Long-Term Follow-Up Study of Unilateral Microtia Patients Who Participated in Study AUR 201 05 and Had the AUR-201 Implant in Place at Final Visit (24 Weeks After the First Implantation Surgery)
Long-term follow-up of unilateral microtia patients implanted with AUR-201.
NCT06078566 — Microtia
Status: Recruiting
http://inclinicaltrials.com/microtia/NCT06078566/
A Phase 1/2, Multi-Center, Open-Label, Single-Arm Safety, Tolerability, and Efficacy Study of an Auricle and Wedge Subcutaneous Implant Combination Product (AUR-201) in Patients With Unilateral Microtia
AUR-201 is indicated for the treatment of Grade II, III, or IV unilateral microtia in patients 8 to 29 years of age.
NCT06072040 — Microtia
Status: Recruiting
http://inclinicaltrials.com/microtia/NCT06072040/
Auricular Reconstruction in Microtia by Medpor Implant Following Tissue Expansion
The study involves patients with microtia of certain criteria will undergo tissue expansion by silicone bags in the postauricular region then Medpor implants will be applied undercover of the expanded skin for reconstruction of the auricule instead of the costal cartilage graft
NCT05068362 — Microtia
Status: Recruiting
http://inclinicaltrials.com/microtia/NCT05068362/
Erector Spinae Plane Block for Rib Cartilage Graft Reconstruction Surgery
The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. This study is being performed to assess the effectiveness of this technique in reducing post-operative pain scores and opiate requirements in pediatric and adult patients undergoing rib cartilage grafting surgeries.
NCT03729427 — Anesthesia
Status: Not yet recruiting
http://inclinicaltrials.com/anesthesia/NCT03729427/
Use of Silicone Gel to Improve Retroauricular Scar in Microtia Patients
Effort to reduce post-surgical scar is especially important for microtia patients. Even the scar lies posterior to ear auricle, but hypertrophic scar contracture may limit the ear auricle projection. If the scar is hypertrophic and conspicuous, this stigmata will accompanies the child for many years.The main objective aim of this study is to examine whether post-operative use of silicone gel can improve scar formation for microtia reconstruction scars.
NCT02518035 — Scar
Status: Recruiting
http://inclinicaltrials.com/scar/NCT02518035/
Tissue Engineering Microtia Auricular Reconstruction: in Vitro and in Vivo Studies
Platelet-rich plasma (PRP) has mixed growth factors such as TGF-ß1 and TGF-ß2, vascular epithelial growth factor (VEGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF). These growth factors appear to play an important role in wound healing and are assumed as promoters of tissue regeneration. Moreover, PRP was used as injectable scaffold seeded with chondrocytes to regenerate cartilage. In their previous study, the investigators concluded that growth factors in PRP can effectively react as a growth factor cocktail to induce human nucleus pulposus proliferation and differentiation, and also promote tissue-engineered nucleus pulposus formation. The investigators also have a hypothesis that PRP can promote tissue-engineered microtia auricular cartilage formation. TGF- ß1 exists in the highest concentration and is more important among all of the growth factors released from PRP. So TGF- ß1 can be used as the core ingredient and the indicator for applying PRP in these studies. The aim of this study was to compare the histological and biochemical character of microtia chondrocytes treated with and without PRP.
NCT00958802 — Microtia
Status: Completed
http://inclinicaltrials.com/microtia/NCT00958802/
Secondary Ear Reconstructions Based on Nagata Method for Unsatisfactory Outcomes After Microtia Surgeries
The goal of this observational study is to provide a feasible surgical strategy based on Nagata method for patients who require secondary revision surgeries and to verify its long-term aesthetic outcomes. The main question it aims to answer is: • Whether ear reconstruction surgery based on Nagata method can improve the unsatisfactory outcomes of primary reconstruction surgery? Participants who had accepted secondary ear reconstruction based on Nagata method in our department will be required to received questionnaires in the follow-up and their photographs will be collected for reconstructed ear evaluation of its realness through convolutional neural network (CNN) models we previously developed.
NCT05604456 — Secondary Ear Reconstructions Based on Nagata Method
Status: Completed
http://inclinicaltrials.com/secondary-ear-reconstructions-based-on-nagata-method/NCT05604456/
Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work? A Randomized Controlled Clinical Trial of Microtia Patients
Donor-site pain is an adverse effect of autologous ear reconstruction. A well-planned pain management protocol is needed. The objective of this study was to introduce rectus abdominis and external oblique muscle infiltration analgesia (RAM+EOM-IA) in autologous ear reconstruction and to evaluate its efficacy and safety.
NCT06118216 — Rectus Abdominis and External Oblique Muscle Infiltration Analgesia
Status: Completed
http://inclinicaltrials.com/rectus-abdominis-and-external-oblique-muscle-infiltration-analgesia/NCT06118216/
A Multicenter, Single Arm, Prospective, Open-Label, Staged Study of the Safety and Efficacy of the AuriNovo Construct for Auricular Reconstruction in Subjects With Unilateral Microtia
AuriNovo provides a patient-specific, biological construct for use in the surgical reconstruction of the external ear in people born with microtia Grades II-IV. This Phase 1 / 2A study is being conducted to collect preliminary safety data on microtic ear reconstruction using AuriNovo, fine-tune technical, logistical, surgical, and post-surgical care aspects related to implantation, and to gather preliminary efficacy data including short- and longer-term in vivo duration and biological status of the implant.
NCT04399239 — Microtia
Status: Terminated
http://inclinicaltrials.com/microtia/NCT04399239/