Effect Of Topical Phenytoin In Pressure Injury Healing In Spinal Cord Injury Patients- a randomised controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- 1 PUSH 3.0 SCORE BASED ON ULCER LENGTH X LENGTH IN CENTIMETRE SQUARE EXUDATE AMOUNT TISSUE TYPE
研究概览
简要总结
| 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •NPUAC stage 2 and 3 pressure injury.
排除标准
- •Elevated serum creatinine
- •Abnormal liver function tests
- •those receiving oral phenytoin for any concurrent medical problem
- •a history of adverse effects caused by phenytoin.
结局指标
主要结局
1 PUSH 3.0 SCORE BASED ON ULCER LENGTH X LENGTH IN CENTIMETRE SQUARE EXUDATE AMOUNT TISSUE TYPE
时间窗: PUSH 3.0 SCORE - baseline, on 5th day, 10th day and 15th day
2 ULCER VOLUME MEASURED BY FILLING THE ULCER UPTO THE BRIM WITH NORMAL SALINE AND WITHDRAWN USING CALIBRATED SYRINGE
时间窗: PUSH 3.0 SCORE - baseline, on 5th day, 10th day and 15th day
次要结局
- ADVERSE EFFECTS ON APPLICATION OF TOPICAL PHENYTOIN LIKE LOCAL SKIN IRRITATION(COST COMPARISON OF PHENYTOIN INJECTION VIALS AND COLLAGEN DRESSING SHEETS)
研究者
Dr Archana N
Tamil Nadu Dr MGR Medical University