Determination of Amniotic Membrane in the treatment of Extravasation in infants
Design
Single-arm clinical trial on 4 patients with wound due to Extravasation, a pilot study
Settings and conduct
The untreated or uncontrolled wound due to extravasation could lead to tissue disorders, necrosis, scar, movement limitation and even amputation in Infants. The use of Amniotic Membrane as an Allograft could act a crucial role in its treatment. After hospitalization of patient in Children's Medical Center, the amniotic membrane will be used weekly under observation of physician until epithelization as wound cover after wound assessment and treatment of infection and necrotic tissue (if exists) .
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Infants who suffered wound higher than stage 2, due to Estravasation.
Exclusion Criteria: Infants with congenital skin disorders.
Intervention groups
Amniotic Membrane dressing (Sinacell Co.) as Allograft every 7 days, dressing size selection based on wound dimensions, until epithelization
Main outcome variables
Time to epithelization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191024045229N2
Registration date:2020-02-02, 1398/11/13
Registration timing:registered_while_recruiting
Last update:2020-02-02, 1398/11/13
Update count:0
Registration date
2020-02-02, 1398/11/13
Registrant information
Name
Kayvan Mirnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6642 8998
Email address
kmirnia@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-20, 1398/10/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation Efficacy of Amniotic Membrane in Treatment of Extravasation in Infants
Public title
Amniotic Membrane in Extravsation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infant with diagnosis of wound due to drug leak
Exclusion criteria:
Wound with stage 1 or 2
Congenital skin disorders
Age
From 1 day old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
4
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 Tehran University of Medical Sciences
Street address
Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-10-07, 1398/07/15
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.530
Health conditions studied
1
Description of health condition studied
Extravasation Leak
ICD-10 code
T80.818A
ICD-10 code description
Extravasation of other vesicant agent, initial encounter
Primary outcomes
1
Description
Time to epithelization
Timepoint
Before intervention and weekly until epithelization
Method of measurement
Logging the time (day)
Secondary outcomes
1
Description
Scar Forming after Wound Treatment
Timepoint
After Wound Healing
Method of measurement
'Vancouver Scare Scale' questionnaire
2
Description
Hospitalization Period
Timepoint
During the Study until epithelization
Method of measurement
Documents Assessment
3
Description
Sepsis
Timepoint
Before the initiation of intervention and then weekly
Method of measurement
Clinical assessment and blood sampling
Intervention groups
1
Description
Intervention group: Intervention group: Amniotic Membrane dressing (Sinacell Co.) as Allograft every 7 days, dressing size selection based on wound dimensions, until epithelization
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Children's Medical Center
Full name of responsible person
Kayvan Mirnia
Street address
Gharib St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
cmcpr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraian
Street address
Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Malihe Kadivar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatology
Street address
Gharib St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
Kadivarm@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kayvan Mirnia
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Neonatology
Street address
Gharib St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
kayvanmirnia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Maryam Amini Pouya
Position
Non-faculty Pharm. D
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Qods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8889 6696
Email
maryam.aminipooya@gmail.com
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
Undecided - It is not yet known if there will be a plan to make this available
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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available