Protocol summary
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Study aim
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Evaluation Effects Of Arnebia euchroma Ointment with Silver nanoparticles Dressing on Pressure Ulcer Pain and its Healing
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Design
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This study is a Randomized controlled clinical trial with parallel groups and single-blinded.
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Settings and conduct
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The Research sample size consists of 60 patients with grade 2,3 and 4 Pressure ulcers (intervention group30, control group 30) admitted to Khatam and Aliebene-Abi-Taleb hospitals in Zahedan city in 2022- 2023
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Age over 18 years. Second-degree, Three-degree, and Four-degree Pressure ulcers. Hospitalized patients. Normal Serum Albumin Levels, Nonverbal communication.
Exclusion Criteria:
Alcoholism, Immune system failure, liver failure, Not having a wavy mattress
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Intervention groups
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The Intervention in this study is using the Arnebia euchroma Ointment. In the control group, the intervention uses Silver nanoparticles dressing. The wound will be checked by push-scale on days 1,7,12 and the pain of change dressing will be checked by a nonverbal pain scale
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Main outcome variables
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The Healing rate of Pressure ulcer
General information
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Reason for update
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Completion of clinical trial
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220308054222N1
Registration date:
2022-08-02, 1401/05/11
Registration timing:
prospective
Last update:
2024-04-17, 1403/01/29
Update count:
1
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Registration date
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2022-08-02, 1401/05/11
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-08-16, 1401/05/25
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Expected recruitment end date
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2022-12-21, 1401/09/30
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Actual recruitment start date
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2022-09-23, 1401/07/01
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Actual recruitment end date
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2023-05-20, 1402/02/30
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Trial completion date
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2023-05-20, 1402/02/30
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Scientific title
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Comparison of the Effectiveness of Arnebia euchroma Ointment and Silver nanoparticles dressing on pain and Pressure Ulcer healing
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Public title
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A Survey of the effectiveness of Arnebia euchroma Ointment and Silver nanoparticles dressing on pain and Pressure Ulcer healing
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
patients with pressure ulcers grade 2 ,3 and 4
nonverbal patient
Using a wavy mattress
Albumin level above 3 mg/dL
Presence of pain in the area
Exclusion criteria:
A history of any allergy to Arnebia euchroma and silver
Use of other dressings during the intervention
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Age
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From 18 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, randomization is first done by random sequence generation. A simple randomization method will be used to generate a random sequence. The method of simple randomization in this study is the use of a random number table. A random number table is a set of numbers that are generated without a specific pattern or order and in a completely random form and has become a table. In order to use the table of random numbers, we first preset the table to read the numbers (from left to right). Then the numbers are considered for the study groups so that even numbers will be considered for the experimental group and odd numbers will be considered for the control group. The second step is the concealment of the randomization allocation because the assigned group will not be specified before the individual is assigned. In this study, due to the fact that sampling is multicenter, the central randomization method will be used to hide the allocation. In this method, the random sequence is given to a person in the school of Nursing and sampling is performed in two centers. Based on the order in which the participants entered the study, the researcher contacted the mentioned person in the School of Nursing and asked about the random assignment of the participant to the experimental or control group. Communication method include the use of telephone.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study is Single blind. The outcome evaluator don't knows the groups and is unaware of type of treatment in each group.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-07-24, 1401/05/02
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Ethics committee reference number
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IR.ZAUMS.REC.1401.140
Health conditions studied
1
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Description of health condition studied
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pressure ulcer
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ICD-10 code
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L89
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ICD-10 code description
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Pressure ulcer
Primary outcomes
1
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Description
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Wound Healing
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Timepoint
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The first, seventh, and twelfth day
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Method of measurement
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Pressure Ulcer Scale for Healing (PUSH Tool)
2
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Description
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Pain
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Timepoint
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The first, seventh, and twelfth day
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Method of measurement
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Nonverbal Pain Scale (NVPS)
Intervention groups
1
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Description
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Control group: For 12 days, After Washing the Wound with Sodium Chloride Irrigation Solution 0.9%, the Wound is Dressed with Silver nanoparticle Dressing (AGICOAT) Once Every Three Days. And on the First, Seventh, and Twelfth Days, The Condition of The Wound and the Level of Pain Experienced Will be Measured.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: For 12 days, After Washing the Wound with Sodium Chloride Irrigation Solution 0.9%, the Wound is Dressed with Arnebia Euchroma Ointment (GOUROH Ointment) and Sterile Gauze Pads Once Every Two Days. And on the First, Seventh, and Twelfth Days, The Condition of The Wound and the Level of Pain Experienced Will be Measured.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zahedan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Part of the data is related to the main outcome and the secondary outcome can be shared.
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When the data will become available and for how long
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The access period starts 3 months after the results are published
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To whom data/document is available
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The data is available to researchers working in academic and scientific institutions as well as people working in the industry.
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Under which criteria data/document could be used
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Use as a reference
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From where data/document is obtainable
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DR.Simin sharifi,
siminsharifi1@gmail.com
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What processes are involved for a request to access data/document
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After making a call via email or phone, the desired data will be sent using email or post.
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Comments
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