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CTRI Number  CTRI/2024/05/066594 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study of Burden of Pressure Sores in the ICU and HDU setting in a tertiary care Hospital in South India  
Scientific Title of Study   A Cross- Sectional Prevalence Study of Pressure Injuries in Intensive Care Units and High Dependency Units of a Tertiary Care Hospital in South India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Joseph Thomas  
Designation  ASSOCIATE PROFESSOR  
Affiliation  Kasturba Medical College, Manipal 
Address  Dept. of Plastic Surgery, Kasturba Hospital

Udupi
KARNATAKA
576104
India 
Phone  9995783582  
Fax    
Email  dr.joethomas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Joseph Thomas  
Designation  ASSOCIATE PROFESSOR  
Affiliation  Kasturba Medical College, Manipal 
Address  Dept. of Plastic Surgery, Kasturba Hospital

Udupi
KARNATAKA
576104
India 
Phone  9995783582  
Fax    
Email  dr.joethomas@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Joseph Thomas  
Designation  ASSOCIATE PROFESSOR  
Affiliation  Kasturba Medical College, Manipal 
Address  Dept. of Plastic Surgery, Kasturba Hospital

Udupi
KARNATAKA
576104
India 
Phone  9995783582  
Fax    
Email  dr.joethomas@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College, Manipal 
 
Primary Sponsor  
Name  Dr Joseph Thomas  
Address  Dept of plastic surgery, Kasturba hospital 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Joseph Thomas   Kasturba Medical College  Department of Plastic Surgery
Udupi
KARNATAKA 
9995783582

dr.joethomas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L89||Pressure ulcer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients at or more than 18 years admitted to ICUs and HDUs of a tertiary care hospital in South India who develop pressure injuries during their stay 
 
ExclusionCriteria 
Details  Patients with wounds of other aetiology in areas most commonly associated with pressure injures
Patients less than 18 years
Patients who do not consent to the study 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A the end of 6 weeks we will determine the prevalence of pressure sores inpatients admitted in ICUs and HDU’s from the data collected  A the end of 6 weeks we will determine the prevalence of pressure sores inpatients admitted in ICUs and HDU’s from the data collected 
 
Secondary Outcome  
Outcome  TimePoints 
Aid health care policy-makers to understand the prevalence of this problem in patients admitted to ICUs and HDUs of a tertiary hospital in south India and implement effective interventions to control and reduce this problem.  6 weeks from start of study 
 
Target Sample Size   Total Sample Size="113"
Sample Size from India="113" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="1"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Pressure injuries, also known as a pressure ulcer, pressure sore or bed sore, is defined as a localized lesion in skin and/or underlying tissues, often in areas of bony prominences, such as the heels, hips, sacrum, or elbows. It is caused by prolonged pressure or a combination of pressure, shear, and friction forces. (1) The severity of pressure ulcers can range from mild skin redness (stage 1) to partial or full-thickness tissue loss, including fat, muscle, and bone (stages 2, 3, and 4). (2).  Morbidities like diabetes, smoking, malnutrition, vascular diseases, prolonged immobility, moisture, sleeping on hard surfaces and sensory disturbances contribute to increased prevalence of pressure sores. Pressure sores are an indicator of a patient’s safety and quality of care. A study conducted by Barratt et al. showed that pressure sores increase the workload of health care providers by 50%. (3)

Prevalence varies in different health centers and from country to country. Following cancer and cardiac disease, pressure injuries are  the  most  expensive health care problem in all care settings. (10) Proper prevention, early detection, and appropriate management are crucial in the care of pressure ulcers. Healthcare professionals, including nurses, doctors, and wound care specialists, play an essential role in assessing and providing treatment for individuals with pressure ulcers. Awareness of the status of pressure injuries  is  the  first step  in  planning  for the reduction of its prevalence in ICUs. Having an accurate estimation of the prevalence of PU  in  ICUs and HDUs can thus be beneficial in making informed healthcare decisions to effectively manage and control this issue.



 
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