Compression in Anklefracture Treatment, The CAT-study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- number of participants with post-surgical wound infection, after ankle fracture operation,
研究概览
简要总结
The aim of this project is to find out if compression treatment can lower the incidens of surgical wound complications, such as infection and wound rupture, in patients with ankle fractures. The compression regime consists of a two-layered compression stocking applied after surgery and a massage boot applied both before and after surgery.
The largest part of the study is the clinical trial, with which we aim to prove the hypothesis:
* That the compression regime reduces wound infections from 10-40% to 5% on patients with a broken ankle (Either one side of the ankle, two or three sides (including the posterior part of the ankle))
详细描述
Malleolar fractures
Surgical treatment of patients with malleolar fractures imposes a special challenge for orthopaedic surgeons. A typical ankle fracture results in haematoma, sometimes blistering and almost always oedema formation. This postpones the optimal time for surgery. When operating on a swollen ankle, it becomes obvious for the surgeon that the tissue elasticity and normal structure is changed. This can complicate the surgical approach, procedure, the reduction of the fracture and the closure of the incision. Quite often the skin is difficult to adapt, resulting in excessive tension on the sutures. This can potentially lead to skin necrosis and wound dehiscence. Blood and fluid imbibed tissue and prolonged operating time, increases the risk of post-operative infection, and thereby give the patient painful and extended post-operative course.
When striving to give the patient a good treatment and rehabilitation, it is paramount to prevent surgical complications.
Compression therapy, as part of the standard treatment of ankle fractures, is not yet described in the literature and no previous study has tested its efficiency in this patient group, in a systematic manner. It is a new, innovative way of helping the patients to faster rehabilitation and to prevent surgical soft tissue complications.
If this study proves the expected effect on soft tissue complications, compression therapy will probably also show an effect on other fracture types: knee-, wrist-, tibia- and femoral fractures, making compression therapy an integrated part of the standard fracture regime in all orthopaedic departments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •All patients operated on Nordsjællands Hospital, department of Orthopaedic surgery, during the inclusion period, for mono-, bi- and trimalleolar fracture, according to the AO-principles.
- •Age above 18 years.
排除标准
- •Sub study 1:
- •Age under 18
- •Need for external fixation
- •Known or suspected DVT or pulmonary embolism
- •Patients without Danish CPR-number, or address in Denmark
- •Patients who doesn´t want to participate or who are not able to give written or oral consent
- •No palpable pulse in the foot in the affected leg (the posterior tibial,- or dorsal artery)
- •Multi-traumatized patients and patients with fractures of more than one extremity
- •Sub study 2:
- •Age under 18
- •Need for external fixation
- •Multi-traumatized patients and patients with fractures of more than one extremity
结局指标
主要结局
number of participants with post-surgical wound infection, after ankle fracture operation,
时间窗: Within the first 6 weeks after surgery.
The project manager will evaluate the patient twice during the 6 weeks follow-up, in the out-patient clinic. Clinical pictures will be taken at each visit, for two senior doctors to perform a blinded evaluation according to the primary outcome. Infection is defined as Increased pain, swelling, pus secretion, redness, or warmth around the affected area. Need for antibiotics. Not all signs has to be present. The outcome is registred as "number of patients with infection"
次要结局
- Wound dehiscence.(Within the first 6 weeks after surgery.)
- Skin necrosis.(Within the first 6 weeks after surgery.)
- Visible osteosynthesis material(Within the first 6 weeks after surgery.)
- Blisters(Within the first 6 weeks after surgery.)
- Amputation(Within the first 6 weeks after surgery.)
- Deep venous thrombosis(Within the first 6 weeks after surgery.)
- Death(Within the first 6 weeks after surgery.)
研究者
Rikke Winge
PhD-student, MD
Hillerod Hospital, Denmark