| CTRI Number |
CTRI/2024/12/078776 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Creating and testing of a special nursing care plan for patients with wounds. |
|
Scientific Title of Study
|
Development, Validation and Evaluation of the comparative efficacy of nursing care protocol for patient receiving platelet rich plasma therapy as against conventional nursing care for early promotion of wound healing. |
| 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 Samruddhi Gujar |
| Designation |
PhD scholar |
| Affiliation |
Datta Meghe Institute Of Higher Education &Research (Deemed to be University ) |
| Address |
Department of Medical Surgical Nursing Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9970344231 |
| Fax |
|
| Email |
samruddhigujar2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjana Sharma |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education &Research (Deemed to be University ) |
| Address |
Department of Medical Surgical Nursing Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjana Sharma |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute Of Higher Education &Research (Deemed to be University ) |
| Address |
Department of Medical Surgical Nursing Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960027855 |
| Fax |
|
| Email |
ranjanasharma1234@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher education and Research, Sawangi Meghe,Wardha,India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher education and Research |
| Address |
Sawangi Meghe,Wardha,India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Samruddhi Gujar |
Acharya Vonoba Bhave Rural Hospital |
Dept of Orthopedics, Block-C, 2nd floor, AVBRH Building, Sawangi Meghe
Wardha
MAHARASHTRA |
9970344231
samruddhigujar2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Protocol of Platelet Rich Plasma therapy |
Nursing care Protocol of Platelet Rich Plasma therapy will be provided to medical and surgical patients. Duration of intervention will be two weeks for each patient. |
| Comparator Agent |
Routine care |
Patients of medical-surgical cases will receive routine care. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Those who are staying for at least six month with the patients
2. Those who are care for client with hard and soft tissue injury.
3.Those who are willing to participate in the study
4. Those who can read and write either of Marathi/Hindi and English.
|
|
| ExclusionCriteria |
| Details |
1. Those who have physical disability and severe sensory deprivation
2. Those who have attended any training programme on post stroke rehabilitation
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early Promotion of wound healing in patients with platelet rich plasma therapy |
Assessment will be done at two weeks and four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in knowledge of nursing staff regarding nursing care protocol on platelet rich plasma therapy |
Assessment will be done at the end of six months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
PRP is the abbreviation for platelet rich plasma. PRP is obtained from
one’s own blood and injected into other areas of the body to trigger a
“healing†process. Platelets are cells in our blood that are part of the
clotting and healing process of our body. During the healing process, platelets
organize and create mild inflammation. During inflammation, platelets release
enzymes that attract stem cells and growth factors. This is done to help repair
damaged tissue. This will be a parallel group randomised control trial in which the comparative
efficacy of nursing care protocol for patient receiving platelet rich plasma
therapy will be assessed against usual nursing care for early promotion of wound healing
among patient admitted in orthopaedic ward. Also we will evaluate the post intervention evaluation
of Knowledge, attitude and practice of staff nurses regarding nursing care
algorithm for patient receiving platelet rich plasma therapy as against usual
nursing care for early promotion of wound healing among patient admitted in
orthopedic ward. |