Clinical Trial of comparison effect of mint gel and placebo gel on incidence rate of pressure ulcer in hospitalized patients with head injury in neurosurgical ICU
This study evaluates the effect of mint gel on prevention of pressure ulcer. The study is a randomized, Triple-blind (patients, researchers and analyst), placebo-controlled, two centered. Supervisor is only person that is aware from gel types. The study population include patients with head injury admitted to intensive care unit. Inclusion criteria: Hospitalization in intensive care due to head injury; transfer to the intensive care unit with endotracheal tube; absence of any underlying disease; No history of allergy to the mint; the lack of pressure ulcers on arrival; Glasgow Coma Scale (GCS) 8 or less. Exclusion criteria: Death or transfer of the patient to ward within 48 hours; patient's unwillingness to cooperate; Sensitivity to mint gel. Sample size includes 70 patients. After arrival to ICU in test group, three times a day (once per shift). we will use a layer of mint gel on skin of areas are at risk for pressure ulcers such as pelvic and bone prominences along routine nursing cares. This work will continue until patient staying in ICU (in 5, 10 and up to 14 days). Control group is similar to test group but for this group we will use of placebo gel. Incidence rate of pressure ulcer will be evaluated by using prepared checklists.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402098665N3
Registration date:2014-03-07, 1392/12/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-07, 1392/12/16
Registrant information
Name
Hassan Babamohamadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
babamohamadi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2014-03-06, 1392/12/15
Expected recruitment end date
2014-12-06, 1393/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial of comparison effect of mint gel and placebo gel on incidence rate of pressure ulcer in hospitalized patients with head injury in neurosurgical ICU
Public title
Effect of mint gel on prevention of pressure ulcer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: Hospitalization in intensive care due to head injury; Patient's transfer to the intensive care unit with endotracheal tube; absence of any underlying disease such as cardiovascular, lung, kidney, diabetes and other chronic disease; No history of allergy to plants in the mint family; The lack of pressure ulcers on arrival; Glasgow Coma Scale (GCS) 8 or less on arrival; Patients with multiple trauma if they do not have restrictions on postural changes are enrolled.
Exclusion Criteria: Death or transfer of the patient within 48 hours; patient's unwillingness to cooperate a few days after admission; Sensitivity to mint gel; inflammation of mucous membrane (the site of gel application); refusing for continuing study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Postal code
3519899951
Approval date
2014-02-19, 1392/11/30
Ethics committee reference number
92/408037
Health conditions studied
1
Description of health condition studied
Decubitus ulcer
ICD-10 code
L89
ICD-10 code description
Decubitus ulcer and pressure area
Primary outcomes
1
Description
Pressure ulcer
Timepoint
Once a day
Method of measurement
Checklists prepared of Bruden tool, present clinical status and National Pressure Ulcer Advisor Panel guide
Secondary outcomes
empty
Intervention groups
1
Description
After patient arrival to ICU in test group, 3 times a day (once per shift) used a layer of mint gel on skin of areas are at risk for pressure ulcers such as pelvic and bone prominences along routine nursing cares. This work will continue until patient staying in ICU (in 5, 10 and up to 14 days).
Category
Prevention
2
Description
After patient arrival to ICU in control group, 3 times a day (once per shift) used a layer of placebo gel on skin of areas are at risk for pressure ulcers such as pelvic and bone prominences along routine nursing cares. This work will continue until patient staying in ICU (in 5, 10 and up to 14 days).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz Namazi Hospital
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Shaheed Rajaei Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Raheb Ghorbani
Street address
Semnan University of Medical Sciences, Vice Chancellor of Research and Technology, Basidj Blv, Semnan, Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4192
Fax
+98 23 1335 4177
Email
babamohamadi@sem-ums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4192
Fax
+98 23 1335 4177
Email
babamohamadi@sem-ums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Hassan Babamohamadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Nursing and Allied Health Faculty, Semnan University of Medical Sciences, 5 Kilometers of Damghan Road, Semnan, Iran
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4192
Fax
+98 23 1335 4177
Email
babamohamadi@sem-ums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)