A Randomized Study on the Effect of Negative-pressure Wound Therapy on Below-the-knee Skin Cancer Graft Reconstruction Complications
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Graft take
研究概览
简要总结
This randomized controlled non-sponsored trial on 60 patients evaluates if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications for skin-cancer surgeries below the knee.
详细描述
Annually, 12 000 skin cancers are diagnosed in Finland. This randomized controlled non-sponsored trial evaluate if a portable negative-pressure device improves graft-take and decrease the risk of surgical complications. 60 patients over 18 years of age are included and randomly assigned to either the negative pressure-treatment group or the conventional treatment group. At the control appointment one-week postsurgery, graft take is documented as a primary outcome and any complications (necrosis, infection, hematoma/seroma) and adverse events (pain, skin reactions) as secondary outcomes. Adverse events are evaluated by a phone call 3 weeks postsurgery and based on medical records 3 months postsurgery.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •from referrals received by the Unit, or from patients undergoing follow-up who have skin cancer (basal cell carcinoma, squamous cell carcinoma or melanoma) or suspected skin cancer below the knee
排除标准
- •Toe lesion, bleeding disorder, severe dementia, critical peripheralischemia, or skin disease that is expected to impair wound healing, such as pyoderma gangrenosum
研究组 & 干预措施
Negative-pressure treatment
A negative pressure wound dressing is placed over the skin graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.
干预措施: Negative pressure device (Device)
Conventional treatment
A conventional antimicrobial wound dressing is placed on top of the graft. Patients are started on compression therapy after surgery, unless there are contraindications, and standard oral and written postoperative immobilization and other treatment instructions are given.
干预措施: Conventional care (Procedure)
结局指标
主要结局
Graft take
时间窗: 3 months
good, partial or poor graft take (%)
次要结局
- Adverse events(3 months)
研究者
Kirsi Isoherranen
Principal investigator
Helsinki University Central Hospital