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CTRI Number  CTRI/2024/04/065532 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 27/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Trial to see the effectiveness of the prophylactic dressing among the high risk cancer patients to prevent the onset of pressure ulcers.  
Scientific Title of Study   The Effectiveness Of Prophylactic Dressing For Prevention Of Onset Of Pressure Ulcer, Compared With No Dressing In High Risk Critical Care Unit Patients: A Randomized Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chitra Sengupta 
Designation  Deputy Nursing Superintendent cum Associate Professor 
Affiliation  Tata Medical Center, Kolkata 
Address  Tata Medical Center, Department of Nursing

Kolkata
WEST BENGAL
700160
India 
Phone  9007110271  
Fax    
Email  chitra2605@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chitra Sengupta 
Designation  Deputy Nursing Superintendent cum Associate Professor 
Affiliation  Tata Medical Center, Kolkata 
Address  Tata Medical Center, Department of Nursing

Kolkata
WEST BENGAL
700160
India 
Phone  9007110271  
Fax    
Email  chitra2605@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chitra Sengupta 
Designation  Deputy Nursing Superintendent cum Associate Professor 
Affiliation  Tata Medical Center, Kolkata 
Address  Tata Medical Center, Department of Nursing

Kolkata
WEST BENGAL
700160
India 
Phone  9007110271  
Fax    
Email  chitra2605@gmail.com  
 
Source of Monetary or Material Support  
Tata Medical Center, Kolkata 
 
Primary Sponsor  
Name  Tata Medical Center Kolkata 
Address  14 MAR EW Newtown Rajarhat Kolkata. 
Type of Sponsor  Private hospital/clinic 
 
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 
Chitra Sengupta  Tata Medical Center, Kolkata  Department of Nursing
Kolkata
WEST BENGAL 
9007110271

chitra2605@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Tata Medical Center-Institutional Review Board (TMC-IRB)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D098||Carcinoma in situ of other specified sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No dressing will be used for the control group.  No dressing will be used for the control group. But both group of patients will be assessed for pre and post skin integrity. 
Intervention  Prophylactic Dressing  Application of prophylactic dressing among the experimental group in critical care units to prevent the onset of pressure ulcer and to maintain the skin integrity. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.CCU patients aged 18 years or older.
2.Patients at high PU risk within 6 hours of entry to CCU.
3.CCU patients with an expected length of stay of at least 3 days
 
 
ExclusionCriteria 
Details  1.Patients with known allergies to the prophylactic dressings.
2.Patients with existing pressure ulcer.
3.Patients who cannot be repositioned owing to medical reasons.
4.Patients on end of life care. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of the application of prophylactic dressing among the experimental group to prevent the onset of pressure ulcer,  3days 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation with selected demographic variables.  6 Months 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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   Phase 3 
Date of First Enrollment (India)   21/04/2024 
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="6"
Days="0" 
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  

Background:


The onset of pressure ulcers (PU) is produced by pressure exerted upon over a bony prominence.

Pressure ulcers are considered adverse events that further complicate the critical state of patients hospitalized with high-complexity problems, causing deaths associated to infection and sepsis.

Pressure injuries have a varying incidence rate of 1% to 40 % and a global prevalence of nearly 20%, with the highest incidence rates observed in intensive care units (ICUs) .

The physical characteristics of hydrocolloid and foam dressings aid in the prevention of pressure injuries.

Studies of PU prevalence in hospitals in Colombia reveal a variation between 2.2% and 10%. Data indicate that 60% of ulcers are developed in intensive and chronic care units during the first two weeks of hospitalization and their risk increases by 74% along with other comorbidities.

Current management strategies target protective dressings to prevent pressure injuries. Dressings are accessible and easily implemented devices.

Purpose:

In our Hospital (175 bedded) on 2017 Hospital Acquired Pressure Ulcer (HAPU) was quite high. As pressure ulcer is a core Nursing Quality Indicator, we had reinforced skin assessment, back care and position changing or repositioning. We came to a decision in our Monthly Nursing Quality Meeting (MNQM) to apply Hydrocolloid dressing patches prophylactically on pressure points and change the same after 72 hours along with other standard HAPU preventive measures. We had started applying the same from 2018 and there was a steady reduction of occurrence HAPU among our oncology patients. But this issue of this application always remain debatable among other disciplines, as they are concerned about the cost of the dressing materials and   the sole efficacy of the dressing material.And the application of prophylactic dressing could not be generalized among all the high risk patients of our hospital.


The objectives for the following research are as follows:


1.To assess whether prophylactic dressings reduce onset of PU in high risk CCU patients compared with no dressings in high risk CCU patients.


2.To evaluate whether no dressing alone reduces the onset of PU in high risk CCU patients.


3.To find out the association between the onset of PU and the selective demographic variables of the high risk CCU patients.




 
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