Fabrication and Clinical trial of biodegradable composite meshes manufactured through additive manufacturing for application in orbital fracture and cleft palate
Clinical evaluation of hydroxyapatite and polycaprolactone surgical mesh fabricated via 3D printing method for cleft palate disorders or orbital floor fractures
Design
This is a non randomized single group clinical trial with 7 patients receiving 3D printed surgical mesh enrolling between March 2023 and March 2024, and will be followed for six months after the surgery.
Settings and conduct
The prepared surgical mesh will be used in 7 patients. After implant placement and fixation, the skin will be sutured. In 7 to 10 days after surgery, a clinical evaluation of the patient will be performed. In 3 and 6 months after surgery, CT scan images will be provided to examine the bone regeneration and implant degradation ratio.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who are suffering from congenital cleft palate disorders and due to the wide gap between the palate usual surgical techniques cannot be applied or patients with traumatic injuries to orbital floor of the skull.
Exclusion criteria: Having an underlying disease, including allergies.
Intervention groups
The diagnostics for this intervention include patients who suffer from cleft palate congenital disorders or patients who have suffered from a traumatic accident and are diagnosed with orbital fractures. During a cranioplasty surgery a 3D-printed mesh will be implanted on the cleft palate opening or will be used to repair the orbital floor fracture. The printed mesh will be fabricated from polycaprolactone and hydroxyapatite compounds by Adli Tissue Regeneration company.
Main outcome variables
close the gap in the roof of the mouth and rearrangement of the muscles and the lining of the palate; orbital floor fracture repair; natural patient ingrowth within the implant's structure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220807055633N2
Registration date:2023-02-25, 1401/12/06
Registration timing:prospective
Last update:2023-02-25, 1401/12/06
Update count:0
Registration date
2023-02-25, 1401/12/06
Registrant information
Name
Seyed Ali Poursamar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3865
Email address
ali.poursamar@amt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-11, 1401/12/20
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Fabrication and Clinical trial of biodegradable composite meshes manufactured through additive manufacturing for application in orbital fracture and cleft palate
Public title
Clinical trials of 3D printing in fabrication of prosthesis for regeneration of cleft palate disorders or orbital fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who have skull and face defects and the use of plates in surgery cannot correct the shape of the bone.
Exclusion criteria:
Having an underlying disease, including allergies
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
7
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Esfahan University of Medical Sciences
Street address
Hezar Jerib Avenue
City
esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2022-12-26, 1401/10/05
Ethics committee reference number
IR.ARI.MUI.REC.1401.251
Health conditions studied
1
Description of health condition studied
Flexible surgical mesh for cleft palate repair
ICD-10 code
Q35.9
ICD-10 code description
Cleft palate, unspecified
2
Description of health condition studied
Flexible surgical mesh for orbital fracture repair
ICD-10 code
S02.3
ICD-10 code description
Fracture of orbital floor
Primary outcomes
1
Description
close the gap in the roof of the mouth and rearrangement of the muscles and the lining of the palate
Timepoint
2 weeks and 4 months after the surgery
Method of measurement
in person patient examination
2
Description
Orbital floor fracture repair
Timepoint
3 and 6 months after the surgery
Method of measurement
in person patient examination and CT-scan imaging
Secondary outcomes
1
Description
natural patient ingrowth within the implants structure
Timepoint
6 months after the surgery
Method of measurement
CT scan imaging and in person patient examination
Intervention groups
1
Description
Intervention group: The diagnostics for this intervention include patients who suffer from cleft palate congenital disorders or patients who have suffered from a traumatic accident and are diagnosed with orbital fractures. During a cranioplasty surgery a 3D-printed mesh will be implanted on the cleft palate opening or will be used to repair the orbital floor fracture. The printed mesh will be fabricated from polycaprolactone and hydroxyapatite compounds by Adli Tissue Regeneration company.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Esfahan University of Medical Sciences
Full name of responsible person
ِSeyed Ali Poursamar
Street address
Hezarjarib Ave
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Hezarjarib Ave
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Seyed Ali Poursamar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
School of Advance Medical Technology, Esfahan University of Medical Sciences, Hezar Jerib Avenue
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hossein Abdali
Position
Assistant Professor
Latest degree
Medical doctor
Other areas of specialty/work
Plastic Surgery
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3865
Email
abdali29223@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
seyed ali poursamar
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
esfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3865
Email
ali.poursamar@amt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available