Comparison Gum gel and foam cushions to prevent bedsores Study: randomized double blind ( The patients and researchers ) Study population: patients with trauma admitted to ICU Inclusion criteria: the age over 15 and under 65 years; Patients without underlying disease (diabetes, skin diseases) and who are admitted to trauma ward ; The risk of bed sores was under 18 according to the Braden Scale score; the minimum duration of stay in the ICU was 5 days. exclusion criteria: the patient died; allergic reactions; appearance of skin redness (onset of bedsores) in study area; Lack of consent or opt-out patients or their families to continue cooperation Interventions: Intervention group (Gum gel pad)؛ control group (Foam pad) Intervention time: from 2016-03-20 until 2016-03-19 The primary outcome: the prevention of pressure ulcers in both groups Secondary outcome: the incidence of pressure ulcers in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091129781N1
Registration date:2016-11-22, 1395/09/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-11-22, 1395/09/02
Registrant information
Name
Javad Shakibamehr
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3542 3970
Email address
shakibamj2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Sabzevar University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Gum gel pads with foam to prevent bedsores in trauma patients admitted to the intensive care unit
Public title
Comparison Gum gel and foam cushions to prevent bedsores
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the age over 15 and under 65 years; Patients without underlying disease (diabetes, skin diseases) and who are admitted to trauma ward ; The risk of bed sores was under 18 according to the Braden Scale score; the minimum duration of stay in the ICU was 5 days. exclusion criteria: the patient died; allergic reactions; appearance of skin redness (onset of bedsores) in study area; Lack of consent or opt-out patients or their families to continue cooperation
Age
From 15 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Sabzevar University of Medical Sciences
Street address
Sabzevar University of Medical Sciences, Sabzevar, Khorasan Razavi
City
Sabzevar
Postal code
Approval date
2016-05-17, 1395/02/28
Ethics committee reference number
IR.medsab.rec.95.14
Health conditions studied
1
Description of health condition studied
Trauma patients admitted to the intensive care unit
ICD-10 code
L89.0
ICD-10 code description
Stage I decubitus ulcer and pressure area
Primary outcomes
1
Description
The prevention of pressure ulcers in both groups
Timepoint
Since the beginning of the study to 10 days
Method of measurement
check list
Secondary outcomes
1
Description
The incidence of pressure ulcers in both groups.
Timepoint
Since the beginning of the study to 10 days
Method of measurement
check list
Intervention groups
1
Description
The control group consisted of patients for whom the foam padding is used
Category
Prevention
2
Description
The intervention group consisted of patients for whom the Gum gel pad is used