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Comparative evaluation of the effect of Aloe Vera Gel and Sildenafil ointment on Pressure ulcers in stage II

Protocol summary

Study aim
The aim of the study is to determine the effect of Aloe Vera Gel and Sildenafil ointment on Pressure ulcer
Design
A clinical trial with a community-based, practice-oriented control group, with parallel groups, not blinding. Randomized random block method
Settings and conduct
The research sample size consists of 120 patients with grade 2 pressure ulcer(intervention group 90, control group 30) in Imam Reza hospital in Kermanshah city in 2017
Participants/Inclusion and exclusion criteria
The inclusion criteria: Physician and patient satisfaction, Aloe vera and sildenafil susceptibility, No wound infection, No skin disease, Diabetes and kidney failure, Age over 18, No drug use The exclusion criteria: platelet loss, need for debridement, unwillingness to cooperate, need for surgery, bleeding and death
Intervention groups
The intervention in this study is using the Aloe Vera Gel(94%)، Ointment sildenafil citrate(.3%) and Combination of Sildenafil Citrate Ointment(.3%) and Aloe Vera Gel(94%).In the control group, the intervention is the use of Comfeel dressing. The wound will be checked by push-scale on days 1,3,7,14,21,30
Main outcome variables
Healing of pressure ulcer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181105041563N1
Registration date: 2018-12-05, 1397/09/14
Registration timing: registered_while_recruiting

Last update: 2018-12-05, 1397/09/14
Update count: 0
Registration date
2018-12-05, 1397/09/14
Registrant information
Name
Somayeh Mahdavikian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
somayeh.mahdavikian@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of Aloe Vera Gel and Sildenafil ointment on Pressure ulcers in stage II
Public title
Comparative of the effect of Aloe Vera Gel and Sildenafil ointment on Pressure ulcers in stage II
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of the physician and the patient to participate in the study Insensitivity to Aloe vera and sildenafil The absence of any signs of wound infection skin disease, having aged over 18 years stage 2 of Starling scale Lack of bleeding earn points equal to 14-6 from Braden scale no addiction to drugs and alcohol no diabetes, and kidney failure
Exclusion criteria:
Reduction of platelets and hemoglobin need for debridement reluctance to continue cooperation need for any surgery bleeding death
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified samples were entered into the study by accessible method and randomly divided into intervention groups (Aloe Vera Gel, sildenafil Ointment and Combination of Aloe Vera Gel and Sildenafil Ointment) and control. Blocks were done as follows: To dressing groups with Aloe Vera Gel, sildenafil Ointment and Combination of Aloe Vera Gel and Sildenafil Ointment was assigned A ، B and C codes respectively, and the control group received D code. The study blocks were ABCD, ABDC, ACBD, ACDB, ADBC, ADCB, and the ABCD block was selected as the first block. Patients were assigned to Aloe Vera Gel, sildenafil Ointment ,Combination of Aloe Vera Gel and Sildenafil Ointment , and control groups, respectively, and this method continued until the samples were completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
KUMS.REC.1396.145

Health conditions studied

1

Description of health condition studied
pressure ulcer
ICD-10 code
L89.1
ICD-10 code description
Stage II decubitus ulcer

Primary outcomes

1

Description
Healing of pressure ulcer
Timepoint
Day one, three, seven, fourteen, twenty one and thirty of the study
Method of measurement
push scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In group 1, the wound will be dressed daily at 8:00 AM with Aloe Vera gel (94%) for 30 days, and will be checked on the days of 1,3,7,14,21,30 by push scale. The brand of this product is Aloe Vera gel and its scientific name Aloe barbadensis Miller. This herb is used as a gel and has antimicrobial and antioxidant effects, increased moisture, anti-inflammatory effects, inhibited thromboxane (an ulcer healing inhibitor), and increased blood flow to the wound site.
Category
Other

2

Description
In group 2, the ulcer will be dressed with sildenafil citrate (. 3%) ointment for 8 days, and will be dressed for 30 days, and will be checked in push-scale on days 1,3,7,14,21,30.The brands of this ointment are Viagra and Revatio. It has nitric oxide compounds, which have been shown to be effective in wound healing. These compounds stimulate cell proliferation, stimulate the activity of fibroblasts, collagen release, antimicrobial effect, antifungal, angiogenesis, increased blood flow to the site of injury and increase the secretion of the growth factor.
Category
Other

3

Description
In group 3, the ulcer, at 8 o'clock in the morning, with a combination of sildenafil citrate ointment(. 3%) and Aloe Vera gel (94%) will be dressed in a 3: 2 ratio for 30 days and will be examined by push-scale on days 1,3,7,14,21,30.
Category
Other

4

Description
Control group: In group 4, the ulcer, up to 30 days, every two days, at 8 o'clock, will be dressed with Hydrocolloid(Comfeel) and will be checked by push-scale on 1,3,7,14,21,30 days
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Somayeh Mahdavikian
Street address
Imam Reza hospital, Baghe abrisham
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
address Vice chancellor for research, Kermanshah University of Medical Sciences, Shahid Beheshty Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
676715987479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Kermanshah 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
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Somayeh Mahdavikian
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Somayeh Mahdavikian
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Somayeh Mahdavikian
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715986479
Phone
+98 83 3816 2560
Email
Somayeh.Mahdavikian@kums.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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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