| 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
|
|
|
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
|
|
|
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.
|