| CTRI Number |
CTRI/2025/04/084863 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Intervention on Hydro cellular dressing to prevent sacral pressure ulcer among bedridden patients |
|
Scientific Title of Study
|
EFFECT OF HYDROCELLULAR DRESSING ON PREVENTION OF SACRAL PRESSURE ULCER AMONG PATIENTS CONFINED TO BED AT KMCH COIMBATORE |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Santhi |
| Designation |
PG NURSING STUDENT MEDICAL SURGICAL NURSING |
| Affiliation |
KMCH college of nursing |
| Address |
Medical Surgical Nursing Department
KMCH Campus
SF NO 259 And 267 Post
Phase II
Room Number 205 Second Floor
Kalapatti Coimbatore
TamilNadu 641048
Medical Surgical Nursing Department
KMCH Campus
SF NO 259 And 267 Post
Phase II
Room Number 205 Second Floor
Kalapatti Coimbatore
TamilNadu 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9585568666 |
| Fax |
|
| Email |
santhidevarayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D Santhi |
| Designation |
PG NURSING STUDENT MEDICAL SURGICAL NURSING |
| Affiliation |
KMCH college of nursing |
| Address |
Medical Surgical Nursing Department KMCH Campus
SF NO 259 And 267 Post
Phase II
Room Number 205 Second Floor
Kalapatti Coimbatore
TamilNadu 641048
Medical Surgical Nursing Department KMCH Campus
SF NO 259 And 267 Post
Phase II
Room Number 205 Second Floor
Kalapatti Coimbatore
TamilNadu 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9585568666 |
| Fax |
|
| Email |
santhidevarayan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
D Santhi |
| Designation |
PG NURSING STUDENT MEDICAL SURGICAL NURSING |
| Affiliation |
KMCH college of nursing |
| Address |
Medical Surgical Nursing Department
KMCH Campus
SF NO 259 And 267 Post
Phase II
Room Number 205 Second Floor
Kalapatti Coimbatore
TamilNadu 641048
Medical Surgical Nursing Department
KMCH Campus
SF NO 259 And 267 Post
Phase II
Room Number 205 Second Floor
Kalapatti Coimbatore
TamilNadu 641048
Coimbatore
TAMIL NADU
641048
India |
| Phone |
9585568666 |
| Fax |
|
| Email |
santhidevarayan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Eighth floor Incubex workspaces
Brigade Triumph Dasarahalli Main road Sector B Hebbal Bengaluru Byatarayanapura CMC and OG Part Karnataka 560092 |
|
|
Primary Sponsor
|
| Name |
Santhi |
| Address |
SF NO 259 And 267 Post
Phase II Kalapatti
Coimbatore
India
TamilNadu 641048 |
| 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 Subhash M Kale |
Kovai Medical Center And Hospital |
Department of Plastic and Microvascular Surgery
Room Number 223
99 Avinashi Road
Peelamedu Pudur Main Road
Civil Aerodrome post Coimbatore
TamilNadu 641014
Coimbatore
TAMIL NADU |
8098555544
kalesubhashm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMCH Institute of Allied Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2 hourly Position Alpha Bed |
Do not give the intervention on Hydrocellular Dressing only given the 2 hourly position Alpha bed provided |
| Intervention |
Hydrocellular Dressing |
Assess the patient Sacral region Then the first 13 days of intervention will be given After the Fourteenth day Assess the Sacral Pressure ulcer In this Hydrocellular Dressing Material is Non adherent antimicrobial agent foam cushion bed present This will helps to Prevents the Sacral Pressure ulcer |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Month(s) |
| Gender |
Both |
| Details |
Both male and female patient between 18 to 65 years of age
patient at high risk for hospital acquired pressure ulcer with Braden scale score |
|
| ExclusionCriteria |
| Details |
patient with prior pressure ulcer lesion in sacral region
patient with known allergies |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of sacral pressure ulcer among patients confined to bed |
Baseline data will be assessed bedridden patients
Till 13 days intervention will be given
After fourteenth days assessed the bed ridden patients will be carried out by WHO Pressure ulcer Grading scale |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The time to sacral pressure ulcer incidence of severity cost effectiveness of dressing and process evaluation |
14 days |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
28/04/2025 |
| 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="30" |
|
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
|
The aim of the study is to assess the effect of Hydrocellular dressing on the prevention of sacral pressure ulcers among patients confined to bed. The main aim of the study is to prevent the development of pressure ulcers among patients who are confined to bed for the purpose of reducing the sacral pressure ulcers. In this study, I am taking 140 high-risk pressure ulcer patients intervention on Hydrocellular dressing will reduce the occurrence of pressure ulcers. Baseline data will be assessed for the patient among bedridden, then a 13-day intervention will be given. After 14 days, assess the patient with the help of the WHO Pressure Ulcer Grading Scale. In this study, the hydrocellular dressing intervention will help the patient reduce the occurrence of pressure ulcers. |