Comparison of the effect of crystalline insulin and topical oxygen on pressure ulcer healing in patients admitted to intensive care units, a single-blind clinical trial
Determining and comparing the effect of crystalline insulin and topical oxygen in the healing of pressure ulcers in patients admitted to the intensive care units of Kashani Hospital in Shahrekord
Design
Clinical trial , Parallel, one-way blind, on 60 patients
Settings and conduct
3rd degree bed sores, hospitalized in the intensive care unit of Kashani Hospital in Shahrekord. There are three groups of topical insulin and topical and control oxygen. Face twice daily for two weeks, in the group with topical oxygen therapy in addition to routine treatment twice daily topical oxygen for 20 minutes and twice a day for 2 weeks and in the control group routine treatments including daily washing with normal saline The wounds are then followed for two weeks.
Participants/Inclusion and exclusion criteria
1. Patients aged 19-65 years who have grade 3 pressure ulcer due to severe concussion (<GCS <8).
2. Do not suffer from organ failure
3. No diabetes, burns, chronic skin disease, diarrhea, vascular problems and hypoalbuminemia
4. No history of smoking, drug or alcohol addiction
5. Absence of infectious symptoms in the wound (swelling, redness around the wound and foul-smelling and purulent discharge)
6. Absence of cachexia symptoms (folds on the back of the arm, the patient's appearance, protrusion of the zygomatic arch and emptying of the temporal cavity)
7. Not taking systemic corticosteroids during the last year
8. The legal guardian of the patient has agreed to participate in the study and has signed the consent form.
Intervention groups
Three groups of recipient intervention: 1- Topical insulin: Insulin recipient with normal saline wash 2- Topical oxygen: Topical oxygen with normal saline wash 3- Control: Normal saline wash only
Main outcome variables
Wound degree
Wound area
The amount of discharge
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210508051228N2
Registration date:2021-08-16, 1400/05/25
Registration timing:registered_while_recruiting
Last update:2021-08-16, 1400/05/25
Update count:0
Registration date
2021-08-16, 1400/05/25
Registrant information
Name
Ali Hasanpourdehkordi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 0064
Email address
a.dehkordi1398@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-28, 1399/12/10
Expected recruitment end date
2021-08-23, 1400/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of crystalline insulin and topical oxygen on pressure ulcer healing in patients admitted to intensive care units, a single-blind clinical trial
Public title
Comparison of the effect of crystalline insulin and topical oxygen on pressure ulcer healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
3rd degree bed sores
Exclusion criteria:
Wounds with other causes
Unfavorable physical condition
Age
From 19 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistical consultant did not know the type of interventions and the names of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
kashani
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Approval date
2021-02-23, 1399/12/05
Ethics committee reference number
IR.SKUMS.REC.1399.263
Health conditions studied
1
Description of health condition studied
bedsore
ICD-10 code
L99
ICD-10 code description
Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Primary outcomes
1
Description
Bed wound healing rate
Timepoint
Before and after the effect of insulin and topical oxygen
Method of measurement
Graduated spatula
Secondary outcomes
1
Description
Wound discharge
Timepoint
After the intervention
Method of measurement
Consumable sterile gas
Intervention groups
1
Description
Intervention group 1: Topical crystal insulin treatment twice a day for two weeks for every 10 cm2 of wound 4 units of regular insulin dissolved in one cc of normal saline and sprayed on the wound with an insulin syringe. Covered with camouflage.
Category
Treatment - Drugs
2
Description
"Intervention group 2": In addition to routine treatment with topical oxygen, they will receive twice daily topical oxygen at a rate of 10 liters per minute for 20 minutes and twice a day for 2 weeks.
Category
Treatment - Drugs
3
Description
"Control group": Routine treatments include daily washing with normal saline and then the wound is covered with a conventional dressing (camphile) and followed for two weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Ismail Tahmasebi
Street address
Varzesh
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3322 9266
Email
miladghaderi4343@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Moezzi
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
mmoezzi@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
80
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Lotfollah Afzali
Position
Research Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Plastic and Cosmetic Surgeon
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
Dr.afzali.sl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Ali Hassanpourdehkordi
Position
Research Consultant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
alihassanpourdehkordi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr. Farrokh Yadalahi Farsani
Position
Research Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Kashani
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 0064
Email
miladghaderi4343@gmail.com
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
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
In the full text of the thesis
When the data will become available and for how long
After the explanation of the thesis
To whom data/document is available
Researchers and students of the centers
Under which criteria data/document could be used
Referral of research work references
From where data/document is obtainable
University Library
What processes are involved for a request to access data/document