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IRCT20220424054640N3 IRCT 2022-09-16 Iran University of Medical Sciences Safety and Efficacy of Acellular Dermal Graft in Orbital Fracture Repair Safety and Efficacy of Acellular Dermal Graft (ADG) in Orbital Fracture Repair; A Pilot Study 2022-09-22 anticipated 10 Complete https://irct.ir/trial/65481 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Condition 1: Inferior wall fracture of orbit. Condition 2: medial wall fracture of orbit. 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.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Nasser Karimi
Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 912 327 2376 drnasserkarimi@gmail.com Iran University of Medical Sciences scientific Nasser Karimi
Sattarkhan
Tehran Iran (Islamic Republic of) 1445613131 +98 912 327 2376 drnasserkarimi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both Patients who previously underwent orbital surgery. S02.3 S02.83 fracture of orbital floor Fracture of medial orbital wall Treatment - Surgery 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. The amount of correction of eye motility. Timepoint: One month, three months and six months after surgery. Method of measurement: examination. The amount of correction of hypoglobus. Timepoint: One month, three months and six months after surgery. Method of measurement: Neugle exophthalmometer. The amount of correction of enophthalmus. Timepoint: One month, three months and six months after surgery. Method of measurement: Hertel exophthalmometer. Prevalence of reactive symptoms to alloplastic material. Timepoint: One month, three months and six months after surgery. Method of measurement: History and examination. The degree of orbit inflammation and infection. Timepoint: One month, three months and six months after surgery. Method of measurement: History and examination. The amount of implant protrusion. Timepoint: One month, three months and six months after surgery. Method of measurement: Examination and CT scan. The rate of visual function loss: visual acuity. Timepoint: One month, three months and six months after surgery. Method of measurement: snallen chart. 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. 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. Iran University of Medical Sciences Approved 2022-08-08 Ethics committee of Iran university of medical sciences Eye Research Center of Iran University: 8th Floor, Seyed al-Shohada Building, Hazrat Rasool hospirtal, Niayesh St., Sattar Khan St., Tehran Tehran Tehran Iran (Islamic Republic of)