Clinical evaluation of the effect of Topical Skin Ointment on the Process of Open Cutaneous Wound Healing
Design
In this study, 56 patients who referred for surgery were divided into two groups of control and intervention and four randomized blocks were used for randomization.
A double-blind study will be.
Settings and conduct
This study is based on the process of wound healing, which is carried out at the Razi Dermatology Hospital.
The patients in the study, were referred to plastic surgery room for skin graft on their scar and burn site, and patients with a 3 × 3 cm skin removal are included in the study. Medical ethics and Consent is under supervision of the Medical Ethics Committee of the Tehran University of Medical Sciences.
The study is a randomized, double blind, clinical trial with two intervention and control groups. After receiving Informed Consent from patients, 56 patients will be selected. Patients are randomly divided into two groups of 28. Randomly, 28 people will be in the intervention group and 28 will be in the control group. The control group treatment is Vaseline.
In this study, the Patients, Researcher and Therapist are blinded.
Ointments will be given in the unbranded and untitled medical cans that patient and therapist be blind.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1- Is Come for Surgery
2- The Lesion Not be Malignant
3- No Specific or Immunosuppressive Disorders
4- Not be Pregnant or in Lactation
5- Not Use Any Specific Drug
6- With Manual or Electric Dermatome a Layer Thickness in 0.04 mm And 3*3 cm in Size from the Thigh Will Removed.
Exclusion Criteria:
1- The Ability to Create Colloid or Scar from the Injuries
2- The presence of Underlying Disease
3- Previous or Current History of Scleroderma
4- Previous Radiotherapy
5- Use Immunosuppressive Medicine or Have Immunodeficiency Disorders
6- Pregnancy or Lactation
7- Use Specific Drug
8- Dissatisfaction to continue use ointment
Intervention groups
The intervention group in this study is a randomly selected 28-person group that uses an alternative medicine to improve the wound healing process.
The control group is a randomly selected 28-person group that uses conventional treatment Vaseline.
Main outcome variables
Less pain; Heal faster
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160118026096N1
Registration date:2018-01-22, 1396/11/02
Registration timing:prospective
Last update:2018-01-22, 1396/11/02
Update count:0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2234 0598
Email address
takzaree@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Evaluation of Topical Skin Ointment on the Process of Wound Healing Ointment: A Double-Blind Randomized Clinical Trial
Public title
The effect of Topical Skin Ointment on the Process of Wound Healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Is Come for Surgery
The Lesion Not be Malignant
No Specific or Immunosuppressive Disorders
Not be Pregnant or in Lactation
Not Use Any Specific Drug
With Manual or Electric Dermatome a Layer Thickness in 0.04 mm And 3*3 cm in Size from the Thigh Will Removed.
Exclusion criteria:
The Ability to Create Colloid or Scar from the Injuries
The presence of Underlying Disease
Previous or Current History of Scleroderma
Previous Radiotherapy
Use Immunosuppressive Medicine or Have Immunodeficiency Disorders
Pregnancy or Lactation
Use Specific Drug
Dissatisfaction to continue use ointment
Age
From 25 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the permuted block randomization will be used with quadruple blocks. Blocks will be generated using Excel software. In order to apply concealment in the randomization process, sealed envelopes will be used, and therefore, before choosing a person, one will not be aware of the type of treatment he will receive.
Blinding (investigator's opinion)
Double blinded
Blinding description
Ointments will be given in the unbranded and untitled medical cans that patient and therapist be blind.
Placebo
Not used
Assignment
Parallel
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
Room 60., Sixth Floor., Tehran University of Medical Sciences., Qods St., Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1396.2641
Health conditions studied
1
Description of health condition studied
Wound Healing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Wound Surface
Timepoint
Day one (surgery day), Day 4, 7 and 14 after surgery
Method of measurement
Wound healing is evaluated by measuring the wound surface, the percentage of wound healing, and the length of time needed for closure and complete repair of the wound. The surface of the wound is measured on days 1, 4, 7 and 14 after the surgery with Ferguson and Logan method. This is accomplished by placing the transparent paper on the wound and draw the wound shape. Then the transparent paper is transferred to the millimeter lattice paper and counted.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group in this study is a randomly selected 28-person group that uses an alternative medicine to improve the wound healing process. The control group is a randomly selected 28-person group that uses conventional treatment Vaseline.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Dermatology Hospital
Full name of responsible person
Nasrin Takzaree
Street address
Vahdat-e-Islami St., District 12., Tehran., Tehran Province
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5563 0174
Fax
+98 21 8895 3008
Email
razihospital@sina.tums.ac.ir
Web page address
http://razihos.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences,Qods Ave. Tehran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Nasrin Takzaree
Position
Assistant professor,School of Medicine, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
School of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 218953008
Fax
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor,School of Medicine, Tehran University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Tehran-School of Medicine, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Email
takzaree@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nasrin Takzaree
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
No.10 ,Porsina Ave.Tehran University of Medical Sciences,School of Medicine
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 8895 3008
Email
takzaree@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Patient recovery results
When the data will become available and for how long
6 months after printing
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
Only recovery results are reported
From where data/document is obtainable
takzaree@tums.ac.ir
What processes are involved for a request to access data/document