Nail Bed Repair With or Without Nail Bed Coverage: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- infection
研究概览
简要总结
A randomized clinical trial conducted at Patel hospital, Karachi, from March 2024 to February 2025, to evaluate infection in patients undergoing nailbed repair with and without nailbed coverage, with minimum follow up for one month post operative.
详细描述
Background:
The fingernail serves as a protective barrier for the dorsal fingertip while also enhancing its aesthetic appeal. Fingertip injuries account for approximately two-thirds of pediatric hand injuries, with nail bed injuries comprising 15% to 24% of these cases. In the United Kingdom, 96% of surgeons routinely remove the nail plate, repair the nail bed, and reposition the nail plate onto the nail bed. The rationale for repositioning includes protecting the repair, reducing infection risk, minimizing pain during dressing changes, and preventing adhesions by supporting the nail fold. When the autologous nail is unavailable, alternatives such as silver foil is used.
Objective:
This study aims to evaluate the risk of surgical site infection after nail bed repair with and without nail bed coverage.
Methods:
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of all age groups and genders,
- •Presented to the emergency or outpatient department within 48 hours of injury,
- •Provided written informed consent (or had consent given by a parent/guardian in the case of minors),
- •Injury to a single finger,
- •Fractures that do not involve an open wound or require fixation.
排除标准
- •Infected injuries,
- •Underlying nail diseases,
- •Pre-existing deformities in the injured or contralateral finger,
- •Distal phalanx fractures requiring fixation,
- •Amputations,
- •Partial or complete loss of the nail bed requiring reconstruction,
- •Multiple nail bed injuries,
- •Known allergies to prescribed postoperative medications.
结局指标
主要结局
infection
时间窗: 30 days
Surgical site infection (SSI) was diagnosed according to CDC guidelines, requiring at least two of the following criteria within 30 days postoperatively: * Purulent discharge * Pain, with a numerical pain scale value of 7 or greater considered positive * Swelling * Erythema, defined as visible redness extending beyond the distal interphalangeal joint compared to the contralateral finger * Tenderness, characterized by pain upon touch
次要结局
未报告次要终点
研究者
Osheen Abbasi
Principal Investigator, Department of Plastic Surgery, Patel Hospital, Karachi
Patel Hospital, Pakistan