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The effect of amniotic membrane extract drops in wound healing of semi-thickness skin donor site in human models

Protocol summary

Summary
We conducted this study to evaluate the effect of amniotic membrane extract drops in semi-thickness skin wound healing. This study is a triple blind randomized clinical trial on 46 patients in need of skin graft surgery. Inclusion criteria: age 18-65 years, requiring skin graft surgery, informed consent Exclusion criteria: Removal of skin graft from the outside of the thigh, conditions and diseases in which the immune system is weakened and wound healing is delayed such as: diabetes, cancer, immune system dysfunction, drugs that suppress the immune system, taking corticosteroids, smoking and alcohol, patients who do not cooperate with treatment and referrals necessary after surgery. Drops deliverer, divides patients randomly by software into two groups. Amniotic membrane extract drops and placebo in identical containers labeled with the patient's name will be sent to the therapist. Skin transplant surgery will be performed in all patients only by one surgeon with the same technique in the patient's groin area. The patient, surgeon and someone who analyzes data are blind to study groups. Skin donor site in two groups is dressed with gauze soaked in amniotic extract and placebo respectively. In all patients wound site in terms of wound healing, pain, infection, cost and scarring will be compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201703148177N16
Registration date: 2017-04-03, 1396/01/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-04-03, 1396/01/14
Registrant information
Name
Mohammad Javad Fatemi
Name of organization / entity
Burn Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
mj-fatemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2017-05-05, 1396/02/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of amniotic membrane extract drops in wound healing of semi-thickness skin donor site in human models
Public title
Amniotic membrane extract drops in wound healing of semi-thickness skin donor site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18-65 years old; requiring skin graft surgery; signing informed consent. Exclusion criteria: removal of skin graft from the outside of the thigh; conditions and diseases in which the immune system is weakened and wound healing is delayed such as: diabetes, cancer, immune system dysfunction, drugs that suppress the immune system, taking corticosteroids, smoking and alcohol; patients who do not cooperate with treatment and referrals necessary after surgery.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Central building of the University of Medical Sciences, Hemmat Highway
City
Tehran
Postal code
1449614535
Approval date
2017-03-14, 1395/12/24
Ethics committee reference number
IR.IUMS.REC.1395.29782

Health conditions studied

1

Description of health condition studied
Wound
ICD-10 code
T14.1
ICD-10 code description
Open wound of unspecified body region

Primary outcomes

1

Description
Wound Healing
Timepoint
Observation, examination and photography on days 1 and 12 after surgery and during spontaneous separation of Vaseline gauze from wound
Method of measurement
Observation, examination and photography

Secondary outcomes

1

Description
Cost
Timepoint
The end of the study
Method of measurement
Cost estimation of the number of drops used in each treatment group

2

Description
Scar
Timepoint
6 months after surgery
Method of measurement
Vancouver Scar Scale, Patient and Observer Scar Assessment Scale (POSAS)

3

Description
Infection
Timepoint
Every 3 days after surgery until complete wound healing
Method of measurement
Observation, examination and wound culture

4

Description
Pain
Timepoint
3, 6 and 12 days after surgery
Method of measurement
Visual Analogue Scale (VAS)

Intervention groups

1

Description
Intervention group: Wound covering of donor site of skin transplantation with amniotic membrane extract drops. From the day of surgery, dressing is changed every 3 days until complete wound healing
Category
Treatment - Drugs

2

Description
Control group: Wound covering of donor site of skin transplantation with solvent amniotic membrane extract drops (normal saline). From the day of surgery, dressing is changed every 3 days until complete wound healing
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Street address
Tehran, Asad Abadi street, Hazrat Fatima Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Javad Mousavi
Street address
Tehran, Central building of the University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

2

Sponsor
Name of organization / entity
Added at 2017-08-20: Royan Institute for Stem Cell Biology and Technology (RI-SCBT
Full name of responsible person
Added at 2017-08-20: Marzieh Ebrahimi
Street address
Royan Institute for Stem Cell Biology and Technology (RI-SCBT), number 82, Akbari alley, Ejazi Ave, Zaferanieh, Tehran
City
Added at 2017-08-20: Tehran
Grant name
بروزرسانی 1396/5/29:
Grant code / Reference number
بروزرسانی 1396/5/29:
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Added at 2017-08-20: Royan Institute for Stem Cell Biology and Technology (RI-SCBT
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Burn Research Center
Full name of responsible person
Tooran Bagheri
Position
Master of Nursing
Other areas of specialty/work
Street address
Shahid Motahari Hospital, Rashid Yasemi Street, Vali-e-asr Avenue, Tehran
City
Tehran
Postal code
1196714353
Phone
+98 21 8888 4275
Fax
Email
tooran_bagheri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Burn Research Center
Full name of responsible person
Mohammad Javad Fatemi
Position
Plastic and Reconstructive surgeon
Other areas of specialty/work
Street address
Shahid Motahari Hospital, Rashid Yasemi Street, Vali-e-asr Avenue, Tehran
City
Tehran
Postal code
1196714353
Phone
+98 21 8888 4275
Fax
Email
mj-fatemi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Tooran Bagheri
Position
Master of Nursing
Other areas of specialty/work
Street address
Shahid Motahari Hospital, Rashid Yasemi Street, Vali-e-asr Avenue, Tehran
City
Tehran
Postal code
1196714353
Phone
+98 21 8888 4275
Fax
Email
tooran_bagheri@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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