| CTRI Number |
CTRI/2024/11/077300 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of local application of phenytoin solution in treatment of pressure ulcer in spinal cord injury patients |
|
Scientific Title of Study
|
Effect Of Topical Phenytoin In Pressure Injury Healing In Spinal Cord Injury Patients- a randomised controlled trial |
| 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 Archana N |
| Designation |
Junior Resident |
| Affiliation |
Tamil Nadu Dr MGR Medical University |
| Address |
Government Institute of Rehabilitation Medicine
dept of PMR
K K NAGAR
CHENNAI
Chennai
TAMIL NADU
600083
India |
| Phone |
9400768085 |
| Fax |
|
| Email |
archanaa214@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Thirunavukkarasu P |
| Designation |
Director and HoD |
| Affiliation |
Tamil Nadu Dr MGR Medical University |
| Address |
Government Institute of Rehabilitation
Department Of Physical Medicine and Rehabilitation
K K NAGAR
CHENNAI
Chennai
TAMIL NADU
600083
India |
| Phone |
9444367919 |
| Fax |
|
| Email |
arasupmr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Archana N |
| Designation |
Junior Resident |
| Affiliation |
Tamil Nadu Dr MGR Medical University |
| Address |
Government Institute of Rehabilitation Medicine
K K NAGAR
CHENNAI
Chennai
TAMIL NADU
600083
India |
| Phone |
9400768085 |
| Fax |
|
| Email |
archanaa214@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Institute of Rehabilitation Medicine
KK Nagar
Chennai
Tamil Nadu
INDIA
PIN 600083 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 ARCHANA N |
Government Institute of Rehabilitation Medicine |
Department of Physical Medicine and Rehabilitation
Male and Female ward
First Floor
KK NAGAR
CHENNAI
Chennai
TAMIL NADU |
9400768085
archanaa214@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madras Medical College, Chennai- 600003 |
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 |
COLLAGEN DRESSING SHEET |
collagen dressing sheet applied for pressure injury on 0, 5th, 10th and 15th day |
| Intervention |
TOPICAL PHENYTOIN APPLICATION FOR PRESSURE ULCER |
Injection phenytoin solution (50 mg/ml) diluted using normal saline (0.9% NaCl) to prepare phenytoin solution (5mg/ml) and applied topically
0-5 cm2 -100mg,5.1-9 cm2 -150 mg,9.1-15 cm2-200mg, 15 cm2 -300 mg on 0, 5th, 10th and 15th days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
NPUAC stage 2 and 3 pressure injury |
|
| ExclusionCriteria |
| Details |
1. Elevated serum creatinine
2. Abnormal liver function tests
3. those receiving oral phenytoin for any concurrent medical problem
4. a history of adverse effects caused by phenytoin |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 PUSH 3.0 SCORE BASED ON ULCER LENGTH X LENGTH IN CENTIMETRE SQUARE EXUDATE AMOUNT TISSUE TYPE
2 ULCER VOLUME MEASURED BY FILLING THE ULCER UPTO THE BRIM WITH NORMAL SALINE AND WITHDRAWN USING CALIBRATED SYRINGE |
PUSH 3.0 SCORE - baseline, on 5th day, 10th day and 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ADVERSE EFFECTS ON APPLICATION OF TOPICAL PHENYTOIN LIKE LOCAL SKIN IRRITATION
COST COMPARISON OF PHENYTOIN INJECTION VIALS AND COLLAGEN DRESSING SHEETS |
on 0 5th 10th & 15th day |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 2 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| 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="1"
Months="0"
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
|
|
Pressure
injuries are common cause of morbidity, mortality and extended hospital stay
among patients with spinal cord injuries.
At present there are wide variety of methods to manage pressure injury but
the quest for an inexpensive, safe and effective topical agent to treat
pressure injury continues.
Phenytoin is an
effective anti-epileptic medication. The possibility of using phenytoin for
wound healing was first recognised in 1939 when it was observed that patients
receiving oral phenytoin had a side-effect of gingival hyperplasia.
It has been
reported that phenytoin may promote ulcer healing by stimulating the
following processes: fibroblast proliferation, collagen deposition , vessel
ingrowth , glucocorticoid antagonism and antibacterial activity as well as
enhancing the number of macrophages in the wound.
Therefore, this study intends to find if topical phenytoin could be used a safe, inexpensive , effective and non-invasive
topical agent for healing pressure injuries.
|
|