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Effect of local application of phenytoin solution in treatment of pressure ulcer in spinal cord injury patients

Effect Of Topical Phenytoin In Pressure Injury Healing In Spinal Cord Injury Patients- a randomised controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/077300
Enrollment
42
Registered
2024-11-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L89- Pressure ulcer

Interventions

Intervention1: 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 topi

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: NPUAC stage 2 and 3 pressure injury

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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SQUARE EXUDATE AMOUNT TISSUE TYPE 2 ULCER VOLUME MEASURED BY FILLING THE ULCER UPTO THE BRIM WITH NORMAL SALINE AND WITHDRAWN USING CALIBRATED SYRINGETimepoint: PUSH 3.0 SCORE - baseline, on 5th day, 10th day and 15th day

Secondary

MeasureTime frame
ADVERSE EFFECTS ON APPLICATION OF TOPICAL PHENYTOIN LIKE LOCAL SKIN IRRITATION COST COMPARISON OF PHENYTOIN INJECTION VIALS AND COLLAGEN DRESSING SHEETSTimepoint: on 0 5th 10th & 15th day

Countries

India

Contacts

Public ContactDr Archana N

Tamil Nadu Dr MGR Medical University

arasupmr@gmail.com9444367919

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026