Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901616502266 Date of Approval: 15/01/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dermis fat grafting in anophthalmia
Official scientific title Dermis fat graft for anophthalmic socket reconstruction, two different techniques.
Brief summary describing the background and objectives of the trial Dermis fat grafting is a well-known technique for anophthalmic socket reconstruction. The dermis is left bare for spontaneous epithelialization which can take 8- 10 weeks, then an ocular prosthesis can be fit. We suppose that dermofat graft with thick dermis layer would heal more rapidly than thin one allowing an earlier fitting of a prothesis. The purpose of this study is to compare 2 different methods if harvesting dermis fat graft; removing epidermis layer using wet cauterization technique resulting in a thick dermis layer versus lamellar dissection by a scalpel resulting in a thinner dermis layer. Primary outcome measure; Complete conjunctival repithelialization with fitting of a prosthesis
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Eye Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2019
Actual trial start date
Anticipated date of last follow up 01/07/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lamellar dissection using scalpel with a thin dermis layer 6 months follow up The epidermis and the superficial dermal layers will be removed using free-hand scalpel dissection leaving a thin dermis layer. The dermis fat graft will be placed within the muscle cone following socket preparation. The conjunctiva will be sutured to the anterior surface of the graft leaving a central area of exposed dermis to re-epithelialize spontaneously. 20 Active-Treatment of Control Group
Experimental Group Removal of the epidermis with wet cauterization leaving a thick dermis layer 6 months follow up The epidermis will be removed using wet cauterization leaving a thick dermis layer. The dermis fat graft will be placed within the muscle cone following socket preparation. The conjunctiva will be sutured to the anterior surface of the graft leaving a central area of exposed dermis to re-epithelialize spontaneously 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Anophthalmia Age (20-40 years) Severe socket scarring. Immunocomromized patients Patients younger than 20 / older than 40. Adult: 19 Year-44 Year 20 Year(s) 40 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/02/2019 Fayoum University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Kiman Fares St Al Fayoum 63521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Complete conjunctival epithelialization with fitting a prosthesis 1month, 2 months, 4 months, and 6 months
Secondary Outcome Socket keratinization, hair growth, granuloma 1 month, 2 months, 4 months ,and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fayoum University Hospital Kiman Fares St AL Fayoum Egypt
Kasr Al Ainy Hospital Kasr Al Ainy St Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mostafa Diab 10 George Nirose St, Al Mesalla Al Fayoum Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mostafa Mohammed Mohammed Diab 10 George Nirose St, Al Mesalla Al Fayoum 63523 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Yomna Amr Alahmadawy 3 Montaser Housing El Haram Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mostafa Diab mmd11@fayoum.edu.eg +201091168842 10 George Nirose St, Al Mesalla
City Postal code Country Position/Affiliation
Al Fayoum Egypt Associate Professor of Ophthalmology Fayoum University Faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries Mostafa Diab mmd11@fayoum.edu.eg +201091168842 10 George Nirose St, Al Mesalla
City Postal code Country Position/Affiliation
Al Fayoum Egypt Associate Professor of Ophthalmology Fayoum University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Yomna Alahmadawy Dr_y.alahmadawy@yahoo.com +201114891792 3 Montaser Housing El Haram
City Postal code Country Position/Affiliation
Giza Egypt Associate Professor Kasr Al Ainy Medical School
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information