Regeneration of auricular cartilage using hybrid implant of PCL-based bioabsorbable plastic and autologous tissues

JRCT ID: jRCTb011240001

Registered date:03/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Congenital (unilateral microtia) and acquired (traumatic, more than 2/3 cranial ear defect after tum
• Date of first enrollment: 03/04/2024
• Target sample size: 3
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

In this clinical research, the reconstruction of the auricle is performed by transplantation of a hybrid auricular implant (hereafter referred to as "hybrid ear implant"), which is composed of the autologous cartilage tissue and biodegradable plastic, into the auricular defect of the patient.
The main intervention is the transplantation of the hybrid ear implant to the subfascial region of the defect.
1) Skin expansion surgery (placement of expander) as a preliminary measure: 1st surgery
2) Removal of expander, removal of cartilage piece as a material from the healthy side: 2nd surgery
3) transplantation of hybrid auricular implant: 2nd surgery
4) Elevation of the implant to improve aesthetics: 3rd surgery
The above three surgeries will be performed in total.

Outcome(s)

• Primary Outcome: Safety of the hybrid implants: The incidence of adverse events

Secondary Outcome

1. Applicability of the test object: Presence of destruction of the test article in the body, exposure, skin deformation, presence of discoloration, duration of postoperative edema
2. Confirmation of the amount and location of cartilage regeneration: MRI (T2 mapping)
3. Occurrence of inflammation associated with implantation surgery that does not depend on the characteristics of the test object: skin congestion, presence of hematoma, presence of local infection
4. Recovery of esthetics: ear length, width, axis, angle (in comparison with those in normal ear)
5. Degradation of test object after implantation: CT value, three-dimensional shape
6. Type, degree, frequency of occurrence, and incidence in the adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 59age old
• Gender: Both

Include criteria

(1) 18 to 59 years old (at the time of informed consent)
(2) In the case of unilateral microtia (both lobular and conchal
types), those who meet the following criteria;
1) Normal or almost normal hairline height
2) No history of surgery to the auricle (no periauricular scarring)
3) No cholesteatoma in patients with conchal type microtia (with external auditory canal present)
(3) In the case of a defect of cranial 2/3 or more of the ear after tumor resection or trauma, there should be no scarring in the surrounding tissue that affects the surgery.
(4) No active local inflammation
(5) No serious skin disorder due to atopic dermatitis or other
skin disease
(6) No history of drug or animal hypersensitivity
(7) Those capable to judge, receive sufficient explanation about this treatment, and understand its content
(8) No signs of serious dysfunction based on the results of interviews and clinical examinations (blood tests)

Exclude criteria

(1) Those who have been diagnosed with malignant tumors or are undergoing treatment
(2) Those who are positive for any of HBs antigen, HCV antibody, HIV antigen/antibody, HTLV-1 antibody, TP antibody and RPR (however, those who are confirmed to be negative for HBV-DNA or who are HCV positive due to a history of hepatitis C vaccination can be registered.)
(3) Those who cannot collect cartilage tissue from the healthy side of the ear
(4) Those who need to wear glasses in daily life
(5) Those who are suspected or positive for porcine dermal collagen or pork allergy
(6) Those who may be allergic to polyglycolic acid (PGA)
(7) Those who are possible for pregnancy, pregnant, or breastfeeding
(8) Those who are unable to obtain written consent
(9) Those who are judged inappropriate by the investigator

Related Information

• Primary Sponsor: Yotsuyanagi Takatoshi
• Secondary Sponsor: Hoshi Kazuto
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development