The goal of this study is comparing efficacy of nifedipine ointment and placebo on healing of bedsore. In a double blind, randomized clinical trial, 100 critically ill patients with grade 1 or 2 of bedsore will be simply randomized in two equal groups; topical nifedipine 3% or placebo ointment. Patients with history of nifedipine hypersensitivity, severe bedsore requiring antibiotic therapy, hospitalization less than 14 days in ICU and worsening of bedsore during treatment course will be excluded from the study. Recruited patients will be received nifedipine or placebo ointment twice daily topically for 14 days. Nifedipine and placebo ointments are same in packaging and the responsible researchers and patients are blinded. Grade of bedsore will be evaluated at baseline and after 14 days of interventions based on the 2-digit Stirling Scale. Change in grade of sore is outcome of study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201705073449N23
Registration date:2017-06-04, 1396/03/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-04, 1396/03/14
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2017-04-25, 1396/02/05
Expected recruitment end date
2018-04-25, 1397/02/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy of nifedipine ointment and placebo on healing of bedsore in critically ill patients: A clinical trial
Public title
Nifedipine ointment in treatment of bedsore
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Critically ill adult patients; with grade 1 or 2 of bedsore; hospitalized in Intensive Care Unit (ICU) for at-least 14 days; without history of nifedipine hypersensitivity reaction.
Exclusion Criteria: Patients with severe bedsore requiring antibiotic therapy; worsening of bedsore during treatment course.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Method of randomization: Simple randomization method using the random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave.
City
Tehran
Postal code
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR.TUMS.PSRC.REC.1396.2132
Health conditions studied
1
Description of health condition studied
Bedsore
ICD-10 code
L89.0
ICD-10 code description
The ulcer appears as a defined area of persistent redness (erythema) in lightly pigmented skin, whereas in darker skin tones, the ulcer may appear with persistent red, blue or purple hues, without skin loss
Primary outcomes
1
Description
Grade of bedsore
Timepoint
At ICU admission and then day 14 of hospitalization
Method of measurement
2-digit Stirling scale
Secondary outcomes
empty
Intervention groups
1
Description
Nifedipine 3% ointment (formulated in the faculty of pharmacy affiliated to Tehran University of Medical Sciences) twice daily topically cover all sores area for 14 days
Category
Treatment - Drugs
2
Description
Placebo ointment (formulated in the faculty of pharmacy affiliated to Tehran University of Medical Sciences) twice daily topically cover all sores area for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Ghods Ave.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm. D
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
City
Tehran
Postal code
Phone
+98 21 6695 4715
Fax
Email
khalilih@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)