Protocol summary

Summary
This study is a cluster randomized controlled trial to examine the effectiveness of multiple intervention strategy in reducing the number of patient pressure ulcer and pressure ulcer related injuries for 38 week at a general hospital in IRAN. The units (clusters) are determined by random allocation before the start of the trial for entrancing to the intervention phase at specific period of times (2 weeks). All clusters start the trial in a control phase with no intervention being delivered in any of them and then sequentially cross over from the control group to the intervention group, until all units are receiving the intervention. A pressure ulcer was defined as localized areas of tissue damage to skin and underlying soft tissue caused by sustained mechanical loading and shearing forces. Inclusion criteria: patient at risk of pressure ulcer with Braden (pressure ulcer risk assessment) scale less than 9, length of stay more than 48 hours in the intensive care unit, ventilator-dependent patients more than 3 days, no medical condition that would preclude the use of re-positioning, consent to participate in the study and exclusion criteria: length of stay less than 48 hours, medical condition that would preclude the use of repositioning. Sample size is accounted base on Woertman’s study. It is estimated that a total of 1280 participants will require intervention. Intervention’s study are assessment of patient with Braden scale, alarm to identify patients prone, patient education, employee education, massage local skin, wound wash regulatory, change position frequently, using wavy mattress, dressing, Daily visit wound care nurse. The primary outcomes are rate of reduction in pressure ulcer surface area and incidence of pressure ulcers in wards and Secondary outcomes are time to healing, percentage of wounds healed, incidence of new pressure ulcers, pressure ulcer prevalence, Grades of new pressure ulcers and length of stay.

General information

Acronym
prevention from pressure ulcer
IRCT registration information
IRCT registration number: IRCT2016042522333N3
Registration date: 2016-05-08, 1395/02/19
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
zhila Najafpour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2117
Email address
zh-najafpour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Endocrinology and Metabolism Clinical Sciences Institute affiliated of Tehran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect patients and staffs education programs to prevention and treatment of pressure ulcers and pressure ulcer-related injuries in a general hospital: A cluster randomized controlled trial
Public title
Prevention and treatment of pressure ulcers
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patient at risk of pressure ulcer with Braden (pressure ulcer risk assessment) scale less than 9; length of stay more than 48 hours in the intensive care unit; ventilator-dependent patients more than 3 days; no medical condition that would preclude the use of re-positioning, consent to participate in the study Exclusion criteria: length of stay less than 48 hours; medical condition that would preclude the use of re-positioning
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 1280
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Endocrinology and Metabolism Clinical Sciences Institute afiilated of Tehran Univercity of Medical S
Street address
Endocrinology and Metabolism Clinical Sciences Institute, Forth Floor, Shariati Hospital, North kargar Avenue
City
Tehran
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.TUMS.EMRI.REC.1395.0051

Health conditions studied

1

Description of health condition studied
Decubitus ulcer
ICD-10 code
L89, L89.0
ICD-10 code description
Decubitus ulcer and pressure area, Stage I decubitus ulcer and pressure area, Stage II decubitus ulcer, Stage III decubitus ulcer, Stage IV decubitus ulcer, Decubitus ulcer and pressure area, unspecified

Primary outcomes

1

Description
Rate of reduction in pressure ulcer surface area, incidence of pressure ulcers
Timepoint
38 weeks
Method of measurement
Checklist, Patient Visit, Screening of Medical Record

Secondary outcomes

1

Description
Time to healing, Percentage of wounds healed, Incidence of new pressure ulcers, Pressure ulcer prevalence, Grades of new pressure ulcers, length of stay
Timepoint
38 weeks
Method of measurement
patient visit, screening of medical record

Intervention groups

1

Description
Assessment of patient with Braden scale, alarm to identify patients prone, patient education, employee education, massage local skin, wound wash regulatory, change position frequently, using wavy mattress, dressing, Daily visit wound care nurse.
Category
Prevention

2

Description
Participants in the control phase receive usual care of hospital that consists of assessment of patients and wound dressing by nurse.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Dr.Mohamad Reza Jafari
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Endocrinology and Metabolism Clinical Sciences Institute afiilated of Tehran Univercity of Medical S
Full name of responsible person
Dr.Mohammad reza Mohajeri
Street address
Endocrinology and Metabolism Clinical Sciences Institute, Forth Floor, Shariati Hospital, North kargar Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Endocrinology and Metabolism Clinical Sciences Institute afiilated of Tehran Univercity of Medical S
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
Endocrinology and Metabolism Clinical Sciences Institute
Full name of responsible person
Dr.Hossein Adibi
Position
Assistant professor
Other areas of specialty/work
Street address
Endocrinology and Metabolism Clinical Sciences Institute, Forth Floor, Shariati Hospital, North kargar Avenue
City
Tehran
Postal code
Phone
+98 228882200
Fax
Email
adibi@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Univercity of Medical Sciences
Full name of responsible person
Zhila Najafpour
Position
PHD Health Care Managment
Other areas of specialty/work
Street address
Economic And Health Managment group, Public Health Faculty, Tehran university of medical sciences, Pour Sina street, 16 Azar street,Tehra, Iran
City
Tehran
Postal code
Phone
+98 218882200
Fax
Email
zh-najafpour@razi.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
zhila Najafpour
Position
PHD Health Care Managment
Other areas of specialty/work
Street address
Economic And Health Managment group, Public Health Faculty, Tehran university of medical sciences, Pour Sina street, 16 Azar street,Tehra, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
zhila.najafpoor@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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