Nail Bed Repair RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oxford Nail Score
研究概览
简要总结
This study compares the outcomes of fixing nail bed injuries with nail bed repair versus irrigation and dressing alone. The main question this study aims to answer is "Does nail bed repair after nail bed injury lead to better outcomes?"
详细描述
This study compares two treatment methods for patients with nail bed injuries. The first method is irrigation and dressing. The second method is nail bed repair. Patients will be randomized into one of the two groups and outcomes will be documented in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients 2+ years of age
- •presenting with disruption of nail plate or laceration adjacent to nail which appears that it may extend into the nail matrix OR subungual hematoma >50% of nail
- •presenting within 3 days of acute injury
排除标准
- •missing (e.g. avulsed) nail bed or segment of nail bed,
- •prior injury to affected nail
- •need for surgical treatment of injury (e.g. underlying operative fracture)
研究组 & 干预措施
Nail bed repair
Patients in this arm will receive the following treatment protocol:
- Block involved digit with 3cc 1% lidocaine injected subcutaneously over volar and dorsal metacarpophalangeal joint
- Apply tourniquet to base of finger if desired
- Remove nail using freer/hemostats
- Irrigate wound with at least 500cc normal saline
- Repair nail bed laceration with 5-0 chromic or monocryl suture
- Fashion substitute nail from foil suture packet, stent eponychium, and secure with 2 absorbable sutures
- Dress finger with bacitracin, Adaptic or xeroform, and 2" kling wrap
- Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed)
- Repair any other lacerations as needed
- Discharge on Keflex x7d with referral for followup in hand clinic in 1-2 weeks
干预措施: Nail Bed Repair (Other)
No nail bed repair (Irrigation and Dressing)
Patients in this arm will receive the following treatment protocol:
- If there is a subungual hematoma >50% of the nail, trephinate the nail plate using an 18G needle
- Irrigate wound with at least 500cc normal saline
- Dress finger with bacitracin, Adaptic or xeroform, and 2" kling wrap
- Splint finger as needed with alumifoam splint (apply splint to volar side of finger so as to avoid pressure to nail bed)
- Repair any other lacerations as needed
- Discharge on Keflex x7d with referral for followup in hand clinic in 1-2 weeks
干预措施: Nail bed dressing (Other)
结局指标
主要结局
Oxford Nail Score
时间窗: From time of treatment, outcomes will be measured at 1-2 weeks, 6 months, 1 year, and 2 years
The Oxford Nail Score assess five cosmetic components marked as binary outcomes composed of nail shape, nail adherence, eponychial appearance, nail surface appearance and presence of a split. The final score is 0-5, where 0 is "least optimal appearance" and 5 is "most optimal appearance."
Oxford Nail Score
时间窗: From time of treatment, outcomes will be measured at 1-2 weeks, 6 weeks, 1 year, and 2 years
The Oxford Nail Score assess five cosmetic components marked as binary outcomes composed of nail shape, nail adherence, eponychial appearance, nail surface appearance and presence of a split. The final score is 0-5, where 0 is "least optimal appearance" and 5 is "most optimal appearance."
次要结局
- Subjective Cosmesis(1-2 weeks, 6 months, 1 year, 2 years)
- NRS Pain score(1-2 weeks, 6 months, 1 year, 2 years)
- Evidence of infection(1-2 weeks, 6 months, 1 year, 2 years)
- Subjective Cosmesis(1-2 weeks, 6 weeks, 1 year, 2 years)
- NRS Pain score(1-2 weeks, 6 weeks, 1 year, 2 years)
- Nail regrowth(1-2 weeks, 6 weeks, 1 year, 2 years)
- Evidence of infection(1-2 weeks, 6 weeks, 1 year, 2 years)
研究者
Anna Luan
Clinical Assistant Professor
Stanford University