Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Healing
研究概览
简要总结
Below knee amputations (BKAs) are frequently performed among vascular patients with end stage chronic limb threatening ischemia and / or complications of diabetes and diabetic foot infections and gangrene, It may also be necessary for patients with aggressive diabetic foot infections or gangrene, or both; for those with extensive venous ulceration; or following major trauma. and in the case of extremity sepsis.
There is two main methods for constructing the myocutaneous flaps in below knee amputation; the long posterior flap (LPF) and skew flap (SF).
详细描述
Anesthesia BKA could be performed under general anesthesia (GA), epidural anesthesia or under spinal anesthesia .
Patient position The patient lies in the supine position. Technique The limb is prepared by an application of povidone iodine solution in the ward 2 h before surgery. The foot and any septic lesion is isolated. The whole limb is wrapped in a dry sterile sheet. Penicillin and metronidazole prophylaxis is used routinely.
The operation is performed under general anesthesia with a regional anesthetic technique.
The skin flaps are marked on the skin before any incision. And the skin flaps are semicircular. based on a line around the limb at right angles to its long axis, drawn at the plane of bone section 10-12cm from the joint line at the tibial plateau.
The skin flaps are cut which includes the fat and deep fascia. but these are not stripped from the underlying muscle more than is required to gain access to the anterior tibial compartment. The saphenous veins are ligated. The periosteum over the tibia is incised where it is exposed and elevated with the skin flap to 2 cm above the line of bone section.
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 with chronic atherosclerotic occlusive disease of the lower extremity and threatening limb ischemia (intractable rest pain, ulcer or gangrene) for whom all other treatment options failed or inapplicable .
- •patients with aggressive diabetic foot infections or gangrene, or both.
- •Patients with extensive venous ulceration.
- •Patients following major trauma with unsalvageable limb.
- •Patients with nonfunctioning damaged limb as in Charcot joint disease.
- •Patients with extensive limb sepsis.
排除标准
- •Patients with local site infection not candidate for instant closure.
- •Patients with bad general condition.
结局指标
主要结局
Healing
时间窗: 6 month
Primary stump healing, defined as a painless, healed suture line enabling fitting of a prosthetic limb (if appropriate) and regaining of mobility
Mobilization
时间窗: 6 month
Number of participants mobilizing with a prosthetic limb.
Re ampuation
时间窗: 1 month
Rate of reamputation at (a) same level; (b) higher level.
次要结局
- Mortality(1 month)
- Hospital stay(1 month)
- complaints(2 month)
研究者
Mohamed Ibrahim Abdelmageed
Ibrahim
Sohag University