The Treatment of Purulent Flexor Tenosynovitis - is Postoperative Catheter Irrigation Necessary? a Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Active range of movement of the most affected finger
研究概览
简要总结
This study evaluates the effect of postoperative intermittent closed-catheter irrigation on the recovery from the purulent flexor tenosynovitis. One group of patients suffering from acute purulent flexor tenosynovitis is treated using intraoperative irrigation only and the other group having both intra- and postoperative irrigation.
详细描述
The foundation of the successful management of purulent flexor tenosynovitis is the surgical debridement followed by an intravenous antibiotic treatment. Several surgical methods have been described to remove the purulent debris from the flexor tendon sheath. Closed-catheter irrigation involves irrigation of the tendon sheath from proximal to distal direction facilitated by two small incisions; one proximal to A1 pulley and one distal to A4 pulley. Lille et al. (J Hand Surg Br. 2000;25(3):304-307) conducted a retrospective study that implied that intraoperative closed-catheter irrigation without postoperative irrigation might be as effective as the combination of intra- and postoperative irrigation.
The hypothesis of this prospective randomized trial is that the intraoperative closed-catheter irrigation alone is as effective as the combination of intraoperative and postoperative intermittent closed-catheter irrigation in the treatment of purulent flexor tenosynovitis.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of purulent flexor tenosynovitis with all four positive Kanavel's signs:
- •symmetric swelling of the entire digit
- •exquisite tenderness along the course of the tendon sheath
- •semiflexed posture of the digit
- •pain with attempted passive extension of the digit
- •age over 18 years
- •patient's willingness to participate in the study
排除标准
- •High-pressure, foreign body or chemical injuries, which require open debridement
- •prisoner, military serviceman, mental retardation or other factors which may affect one's decision making
结局指标
主要结局
Active range of movement of the most affected finger
时间窗: 3 months postoperatively
The total active range of movement is calculated as: (active flexion of MCPJ + PIPJ + DIPJ) - (extension deficit of MCPJ + PIPJ + DIPJ). MCPJ, metacarpophalangeal joint; PIPJ, proximal interphalangeal joint; DIPJ, distal interphalangeal joint.
次要结局
- Need for reoperation(3 months postoperatively)
研究者
Olli Leppänen
Researcher, M.D., Ph.D.
Tampere University