The aim of the study is to determine the effect of hydrogel containing gentamicin on pressure ulcer
Design
This study is a randomized controlled clinical trial with parallel groups and no blinding.
Settings and conduct
The research sample size consists of 105patients with grade 2 pressure ulcer(intervention group 90, control group 30) in Imam Reza hospital in Kermanshah city in 2020-2021
Participants/Inclusion and exclusion criteria
Physician and patient satisfaction, hydrogel and hydrogel containing gentamicin susceptibility,no wound infection,no skin disease,diabetes and kidney failure,age over 18,no drug use,earn points more than 18 from Braden scale،administration of nitroglycerin and immunosuppressive drugs، occurrence of pressure ulcer in order to National Pressure Ulcer Advisory Panel (NPUAP) scale،need for any surgery،need for debridement،bleeding
Intervention groups
The intervention in this study is using Hydrogel and Hydrogel containing gentamicin. 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:IRCT20181105041563N6
Registration date:2020-12-06, 1399/09/16
Registration timing:registered_while_recruiting
Last update:2020-12-06, 1399/09/16
Update count:0
Registration date
2020-12-06, 1399/09/16
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
2020-11-21, 1399/09/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of hydrogel containing gentamicin on pressure ulcers
Public title
Evaluation the effect of hydrogel on pressure ulcer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of the physician and the patient to participate in the study
No addiction to drugs and alcohol,
Insensitivity to hydrogels and gentamicin
Absence of any signs of wound infection and skin disease
Having aged over 18 years
No diabetes, and kidney failure
Stage 2 of The National Pressure Ulcer Advisory Panel (NPUAP) scale
Lack of bleeding
Earn points equal to 14-6 from Braden scale
Exclusion criteria:
Earn points more than 18 from Braden scale
Administration of nitroglycerin and immunosuppressive drugs
Occurrence of pressure ulcer in order to (The National Pressure Ulcer Advisory Panel (NPUAP) scale
Need for any surgery
Need for debridement
Bleeding
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Qualified samples were entered into the study by convenience method and randomly divided into intervention groups (Hydrogel and Hydrogel containing gentamicin) and control. Blocks were done as follows: Hydrogel and Hydrogel containing gentamicin was assigned A and B codes respectively, and the control group received C code. The study blocks were ABC, ACB, BAC, BCA, CAB, CBA, BCC, CAB, CAB, and the ABC block was selected as the first block. Patients were assigned to Hydrogel and Hydrogel containing gentamicin, and control groups, respectively, and this method continued until the samples were completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
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
2019-09-04, 1398/06/13
Ethics committee reference number
IR.KUMS.REC.1398.655
Health conditions studied
1
Description of health condition studied
Pressure ulcer
ICD-10 code
L89
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
First intervention group: in group 1, the wound will be dressed daily at 8:00 AM with hydrogel made by pharmacist researchers of Kermanshah University of Medical Sciences for 30 days, So that the hydrogel covers 2 mm from the wound surface and will be checked on the days of 1,3,7,14,21,30 by Push scale.
Category
Other
2
Description
Second intervention group: in group 2, the wound will be dressed daily at 8:00 AM with hydrogel containing gentamicin made by pharmacist researchers of Kermanshah University of Medical Sciences for 30 days,So that the hydrogel containing gentamicin covers 2 mm from the wound surface and will be checked on the days of 1,3,7,14,21,30 by Push scale.
Category
Other
3
Description
Control group: in group 3 the wound will be dressed every two days at 8:00 AM with 1/2 of the hydrocolloid sheet dressing made by Coloplast Denmark for 30 days, and will be checked on the days of 1,3,7,14,21,30 by Push scale.
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
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street 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
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 University of Medical Sciences
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 University of Medical Sciences
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 University of Medical Sciences
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