Protocol summary

Study aim
Evaluation of the effect of topical erythropoietin in comparison with placebo on the healing of grade 2 burn wounds
Design
Erythropoietin and placebo creams will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy. Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive erythropoietin or placebo creams once a day for two weeks. The steps will be covered by the patient, physician, and evaluators. In this way, the first executor of the sequence plan determines the allocation of people according to the order in which the sick people enter the study and puts the tablets in boxes of the same shape for the patient to consume, and identifies them with codes A or B.
Settings and conduct
Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive erythropoietin or placebo creams once a day for two weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria include referral to the burn center in the first 24 hours after the burn, having a second-degree and deep burn that covers less than 10% of the body surface, no concomitant disease that delays the healing process (such as diabetes, chronic kidney disease, malignancy, and chronic use of corticosteroids), lack of respiratory burns as well as burns with chemicals or electricity, lack of burns on the face, perineum, and hands.
Intervention groups
One group is the erythropoietin cream recipient, the other is the placebo cream recipient.
Main outcome variables
Comparison of wound healing percentage in two groups on days 1, 5, 9, 13

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190810044500N23
Registration date: 2022-03-02, 1400/12/11
Registration timing: prospective

Last update: 2022-03-02, 1400/12/11
Update count: 0
Registration date
2022-03-02, 1400/12/11
Registrant information
Name
Fatemeh Saghafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3419
Email address
f.saghafi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-08-23, 1401/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the efficacy of topical erythropoietin treatment on healing of second degree burned cutaneous burned wounds
Public title
the efficacy of topical erythropoietin treatment on healing of second degree burned cutaneous burned wounds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presenting to the burn center in the first 24 hours after the burn Having grade II burns, superficial and deep, that involve less than 10% of the body's surface area No comorbidity that delays the repair process (such as diabetes, chronic kidney disease, malignancy, and chronic use of corticosteroids) Absence of respiratory burns as well as chemicals or electric burn No burns on the face and perineum and hand
Exclusion criteria:
Concurrent infection during the study Lack of response to treatment The need for skin graft surgery
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to two groups of 24 controls or interventions by the permutation block method. Twelve blocks of four are considered. Generation of random codes using Permuted Block Randomization method will be done with the help of Random allocation software (version 1). The first person who is eligible to enter the study is given number one and likewise, the last eligible person is given number 48. By using the software-generated table, patients receive each intervention A or B (Each of the letters A and B will be installed on similar containers of the interventions). In order to consider blinding in random allocation, the list is given to another person outside the study and using short message service (SMS) before assigning the type of treatment according to the number of eligible people is asked and thus people enter the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
The steps will be covered from the perspective of the patient, the treating physician, and the assessors. The first presenter identifies the sequence of assignments of patients according to the order of entry of the patients into the study, and puts the erythropoietin and placebo creams (identical from color, odor, and shape) into one-size boxes for patient use, and identifies them with A or B codes. The student then delivers the drugs to each individual patient
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of Shahid Sadoughi University Medical Sciencrs
Street address
Shahid Sadoughi university of medical sciences, Professor Hesabi Blvd, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173149
Approval date
2020-07-06, 1399/04/16
Ethics committee reference number
IR.SSU.MEDICINE.REC.1399.059

Health conditions studied

1

Description of health condition studied
Burn
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere

Primary outcomes

1

Description
Mean time of wound healing
Timepoint
The wound healing process is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream on the wound area
Method of measurement
Clinical examination

2

Description
The rate of pigmentation
Timepoint
The rate of pigmentation is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream in the wound area.
Method of measurement
Clinical examination

3

Description
The rate of pain
Timepoint
The rate of pain is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream in the wound area
Method of measurement
Clinical examination

4

Description
The rate of pruritus
Timepoint
The rate of pruritus is measured during the study period on days 1, 3, 7, 10, 14, and 21 after starting to use Erythropoietin cream in the wound area
Method of measurement
Clinical examination

Secondary outcomes

1

Description
Complications observed
Timepoint
End of the study
Method of measurement
Based on the doctor's observation and the person's statements

Intervention groups

1

Description
Intervention group: Erythropoietin cream will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy. Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive erythropoietin cream once a day for two weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo cream will be made in the Pharmaceutics Laboratory of Yazd School of Pharmacy. Patients with second-degree burns referred to Yazd Martyrs Hospital in Yazd will be included in the study. Patients will receive placebo cream once a day for two weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency Department of Shohadaye Mehrab hospital, Yazd
Full name of responsible person
Maryam Jafarpour Semiromy
Street address
Shohadaye Mehrab Hospital (Burn)., Hatamipour Alley., Shahid Sadoughi Burn Hospital Street., Pakenjad Blvd., Moalem Square
City
Yazd
Province
Yazd
Postal code
8917615469
Phone
+98 35 3525 0093
Fax
+98 35 3525 6555
Email
Burn.hospital@chmail.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
South Shahid Sadoughi Blvd., Bahonar Square
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 1171
Fax
+98 35 3724 0371
Email
Ravabet@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy., Shahid Sadoughi university of medical sciences., Shohaday Gomnam blvd
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy., Shahid Sadoughi university of medical sciences., Shohaday Gomnam blvd
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Saghafi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi university of medical sciences, Professor Hesabi blvd, Yazd, Iran.
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3820 3419
Email
F.saghafi@ssu.ac.ir

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
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