Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05068362 |
| Other study ID # |
AssiutU 5 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2021 |
| Est. completion date |
January 2024 |
Study information
| Verified date |
September 2021 |
| Source |
Assiut University |
| Contact |
Mina Youssef Asham |
| Phone |
00201091132336 |
| Email |
minajoe99[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
Description:
Background :
Autologous multistage rib cartilage technique for auricular reconstruction was firstly
introduced by Tanzer in 1959(1) however, such technique had many drawbacks like being a
lengthy process consisting of multiple procedures, donor-site morbidity and pain and the
possibility of cartilage resorption leading to poor ear projection and loss of auricular
definition (2). Tjellström (3) and Korus et al (4) described the osseointegrated implant for
auricular reconstruction in traumatic congenital and oncological conditions. It also had
disadvantages as the need for long-term commitment of both patient and prosthetic team, high
costs of maintenance visits, regular change of the prosthesis every 2 to 5 years and the
prosthesis is considered as a foreign body (5). Medpor is a synthetic biocompatible porous
polyethylene implant (5) that was used as an alternative to conventional autologous rib
cartilage graft for ear reconstruction for the first time by Reinisch (6). This technique was
faced by many arguments like implant fracture, necrosis and failure of healing of the
overlying soft tissue due to foreign body reactions to the Medpor implant (5). Many studies
were conducted to compare those various techniques specially the Medpor implant and rib
cartilage graft but, the superiority of neither of them proved clearly (7).
Aim of the Research :
Evaluation of the outcome of auricular reconstruction in microtia by Medpor implant following
tissue expansion.
Research Methods and techniques:
Type of the study:
Prospective randomized controlled clinical trial study.
Study Setting:
The study will be held in the otorhinolaryngology department of Assiut university hospital
within duration of three years.
Study subjects: The study will include ten patients
Study tools:
All patients will undergo auricular reconstruction by using a prolonged tissue expansion
technique and a Medpor framework at the otorhinolaryngology department of Assiut university
hospital following preoperative evaluation which includes:-
- General examination to detect any other medical conditions.
- Complete ENT examination with special emphasis on describing the deformity.
- Audiological and radiological evaluation.
- Full face right and left profile photograph will be taken to be used in the
postoperative comparison between the operated auricle and the normal one.
The procedure will be performed in steps:-
- Implantation of the suitable tissue expander in the area of the deformed auricle then
after wound healing it will be inflated for three months following removal of
postauricular sutures and wound healing during weekly based visits to the department
out-patient clinic till it will reach full capacity or even beyond to provide adequate
skin for draping the implant.
- The tissue expander will be removed and the Medpor implant "single or double piece" will
be applied and covered by the expanded skin flap. All the ten patients will be followed
postoperatively for at least six months following the final surgical intervention of the
last patient.
Data management and analysis:
Data collection Data will be collected from hospital records about every patient,
preoperative, operative and postoperative notes and reports of the physicians.
Computer software Qualitative data will be presented as percentages. Chi-square test (or
Fisher's Exact test when applicable) will be used for comparisons between the normal and
operated ears regarding qualitative data.
Statistical tests Statistical analysis will be performed with IBM SPSS Statistics Version 20
for Windows.
Ethical Considerations Risk - benefit assessment. Risks and benefits to the participants will
be assessed throughout the research in each step. In case of complications as severe
infection , tissue necrosis and implant extrusion, the research will be terminated, the case
will be considered as failed one and the traditional rib cartilage multistage technique of
microtia reconstruction will be performed instead.
Confidentiality (dealing with data and data dissemination should be confidential).
The participants will be reassured before their participation in the research about the
confidentiality of their personal and medical data as only research team members will deal
with these data. The participants will be reassured that their data will be published in
medical journals only after their permission.
Statement describing the research procedure to be given to the participants. Each participant
will receive a statement describing the research procedure that will be explained and signed
by one of research team members.
Informed consent. Patients or their guardians will be counseled about their participation in
the research and the steps of the surgery including application of the tissue expander, the
weekly visits for inflation of the expander till it will reach the suitable size permitting
enough skin to cover the future device, the possibility of tissue expansion and necrosis and
what will be done in such situations. Also they will be counseled about possible
complications may occur after each step of the surgery and their important role in assessment
of the outcome of the surgery. All the above mentioned points will be written in an informed
consent that will be signed by the patient or his guardian.
Other ethical concerns:
- The research should be conducted only by scientifically qualified and trained personnel.
The research will be conducted only by physicians in charge. - The research should be based
on relevant pre-clinical investigations in animals.
The research is based on previous similar researches performed on patients published in
international medical journals mentioned in the proposal form.
- The consent form must be provided with the proposal Consent of research participation and
surgical procedure
I, the undersigned ................, the child's guardian.............. I agree to
participate in a research which includes a surgical procedure to repair "microtia" a
congenital defect in the ear pinna in two steps. Firstly, tissue expansion by using silicone
bag that are placed under the skin behind the ear for a period of about three months, then
the second stage is to rebuild the deformed ear pinna by using the Medpor stent. The two
stages will be done through a wound behind the deformed ear with knowledge of all the
complications received such as failure to reach the optimal shape. Hematoma under the skin or
severe infections during any stage of the process, damage or refusal of the stent, severe
infections and suppuration of the ear cartilage, which may result in the operation being
completely canceled and another surgical intervention will be performed.
References :
1. Tanzer RC. Total reconstruction of the external ear. Plast ReconstrSurg Transplant Bull
1959.
2. Ali K, Trost JG, Truong TA, Harshbarger RJ 3rd. Total Ear Reconstruction Using Porous
Polyethylene. Semin Plast Surg.2017.
3. Tjellström A. Osseointegrated implants for replacement of absent or defective ears. Clin
Plast Surg 1990.
4. Korus LJ, Wong JN, Wilkes GH. Long-term follow-up of osseointegrated auricular
reconstruction. Plast Reconstr Surg2011.
5. Baluch, N., Nagata, S., Park, C., Wilkes, G. H., Reinisch, J., Kasrai, L., & Fisher, D.
Auricular reconstruction for microtia: A review of available methods. Plastic surgery
(Oakville, Ont.). 2014.
6. Reinisch JF, Lewin S. Ear reconstruction using a porous polyethylene framework and
temporoparietal fascia flap. Facial Plast Surg 2009.
7. Constantine KK, Gilmore J, Lee K, Leach J Jr. Comparison of microtia reconstruction
outcomes using rib cartilage vs porous polyethylene implant. JAMA Facial Plast Surg.
2014.
