1- Evaluation of ADG safety in orbital fracture repair
2- Evaluation of ADG efficacy in orbital fracture repair
Design
This clinical trial (pilot study) will be conducted on 10 patients prospectively.
Settings and conduct
This study is conducted in Rasoul Akram Hospital on patients who come to the hospital with orbital trauma and have an indication for surgical repair of orbital fracture.
Surgery will be performed under general anaesthesia. The surgeon will use transconjunctival method to place ADG in fractured area .The patient will be visited at first and seventh days after operation. the study data will be collected at one month, three months and six months after surgery.
Participants/Inclusion and exclusion criteria
Fracture of the orbital floor or medial wall with one of the following characteristics:
Fractures more than 50% of the orbital floor
Muscle entrapment
Significant enophthalmus
Significant hypoglobus
Intervention groups
In this study, ADG is used for orbital fracture repair in patients with orbital wall fracture who are subject to the inclusion criteria.
This study dose not have a control group.
Main outcome variables
Evaluation of the enophthalmos; hypoglobus; eye movements and diplopia; visual acuity correction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220424054640N3
Registration date:2022-09-16, 1401/06/25
Registration timing:prospective
Last update:2022-09-16, 1401/06/25
Update count:0
Registration date
2022-09-16, 1401/06/25
Registrant information
Name
Nasser Karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 327 2376
Email address
drnasserkarimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2024-03-18, 1402/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and Efficacy of Acellular Dermal Graft (ADG) in Orbital Fracture Repair; A Pilot Study
Public title
Safety and Efficacy of Acellular Dermal Graft in Orbital Fracture Repair
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fracture of the orbital floor or medial wall with one of the following characteristics:
Fractures more than 50% of the orbital floor
Muscle entrapment
Enophthalmus that affecting cosmetic issues
Hypoglobus that affecting cosmetic issues
Exclusion criteria:
Patients who previously underwent orbital surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
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 Iran university of medical sciences
Street address
Eye Research Center of Iran University: 8th Floor, Seyed al-Shohada Building, Hazrat Rasool hospirtal, Niayesh St., Sattar Khan St., Tehran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2022-08-08, 1401/05/17
Ethics committee reference number
IR.IUMS.REC.1401.431
Health conditions studied
1
Description of health condition studied
Inferior wall fracture of orbit
ICD-10 code
S02.3
ICD-10 code description
fracture of orbital floor
2
Description of health condition studied
medial wall fracture of orbit
ICD-10 code
S02.83
ICD-10 code description
Fracture of medial orbital wall
Primary outcomes
1
Description
The amount of correction of eye motility
Timepoint
One month, three months and six months after surgery
Method of measurement
examination
2
Description
The amount of correction of hypoglobus
Timepoint
One month, three months and six months after surgery
Method of measurement
Neugle exophthalmometer
3
Description
The amount of correction of enophthalmus
Timepoint
One month, three months and six months after surgery
Method of measurement
Hertel exophthalmometer
4
Description
Prevalence of reactive symptoms to alloplastic material
Timepoint
One month, three months and six months after surgery
Method of measurement
History and examination
5
Description
The degree of orbit inflammation and infection
Timepoint
One month, three months and six months after surgery
Method of measurement
History and examination
6
Description
The amount of implant protrusion
Timepoint
One month, three months and six months after surgery
Method of measurement
Examination and CT scan
7
Description
The rate of visual function loss: visual acuity
Timepoint
One month, three months and six months after surgery
Method of measurement
snallen chart
8
Description
The rate of visual function loss: Marcus Gunn's pupil
Timepoint
One month, three months and six months after surgery
Method of measurement
examination with muscle light
9
Description
The rate of visual function loss: visual field
Timepoint
One month, three months and six months after surgery
Method of measurement
Humphrey visual field: 24-2 SITA standard
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients will undergo examination and recording of visual acuity, eye movements and exophthalmometery before surgery. CT-scan is performed for all patients before surgery. patients who subject the inclusion criteria will fill the consent form. then a piece of ADG will be ordered from Danesh Banyan company.The nature of Acellular dermal graft (ADG): ADG is processed from donated human dermis and contains collagen and elastin fibers. This product is cell-free due to enzymatic and chemical process. The antigenic property of the product has been removed, but the natural structure of collagen fibers, elastin, basement membrane and its three-dimensional structure are preserved and it is suitable for tissue repair, implantation and proliferation of fibroblasts. This product has two surfaces: a base membrane that prevents the penetration of pathogens into the underlying layers and a skin surface that stimulates Neo-vascularization and connection, stimulation and proliferation of fibroblasts. After providing ADG, according to clinic routines, the patient will go through pre-op anaesthesia proceedings and surgery appointment then will undergo surgery. The surgery will be performed under general anesthesia. The surgeon dose dissection by the transconjunctival method until reaching the lower orbit rim, then the arcus marginalis will be cut and the peri-orbita will be lifted by the elevator. In this way, the extension and location of the fracture is identified and the surgeon will cut a piece of ADG corresponding to the size of the fracture and cover the fracture site. At the end, the peri-orbita will be sewn in place by Vicryl 6.0, and rectus muscles will be checked with forced duction test. After surgery, betamethasone and clobiotic drops four times in a day for one week and oral prednisolone 1 mg/kg with cephalexin 250 mg every 6 hours for five days will prescribed. The patient will be visited at first and seventh day after the operation, and the study data will be collected one month, three months and six months after surgery.