| 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
|
|
|
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
|
|
|
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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