Uses of Irradiated Human Amniotic Membrane in the Treatme... | NCT03942250

NCT03942250

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
Waleed Nemr,Egyptian Atomic Energy Authority	UNKNOWN

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Treated	Experimental	Patients who received REGE pro dressing on EB wounds lesion weekly for 10 weeks	Biological: REGE pro dressing

Name	Type	Description	Arm Group Labels	Other Names
REGE pro dressing	Biological	REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation	Treated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lesion area	The lesion area from the first treatment is greater than 2 cm^2 (grade 3, according to CTCAE v4.0), to the complete healing (= 0 cm^2).	6 weeks
Clinical progression sings	After the first application time: White transperent color of granulation tissue appeared. After the second application time: color dense of granulation tissue increased and covered all over the wound. After the third application time: granulation tissue thickness increased and appeared as a complete homogenous layer. After the fourth application time: depending on lesion depth and size, granulation tissue turned to be pink to red color. After the fifth and sexth application time: Skin layers development appeared.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Patient complain (upon the weekly questionnaire)	The quality of life is scored 0 (minimum) -100 (maximum), the pain reduction is scored 0-100 (as previous) from the first visit till 6 weeks.	6 weeks

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Nashwa K Radwan, PhD	NATIONAL CENTER FOR RADIATION RESEARCH AND TECHNOLOGY	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Amniotic tissue lab		Cairo		29	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29023030	Background	Nemr W, Bashandy AS, Araby E, Khamiss O. Biological Activity Alterations of Human Amniotic Membrane Pre and Post Irradiation Tissue Banking. Pak J Biol Sci. 2016;19(7):289-298. doi: 10.3923/pjbs.2016.289.298.
20466177	Result	Lo V, Lara-Corrales I, Stuparich A, Pope E. Amniotic membrane grafting in patients with epidermolysis bullosa with chronic wounds. J Am Acad Dermatol. 2010 Jun;62(6):1038-44. doi: 10.1016/j.jaad.2009.02.048.

Condition Browse Module

ID	Term
D012868	Skin Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D012873	Skin Diseases, Genetic