The Effect of INPWT on Wound Complications and Clinical Outcomes Following Lower Extremity Sarcoma Surgery in Patients Treated With Preoperative Radiation Therapy: A Multicentre Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 291
- 试验地点
- 2
- 主要终点
- Wound Complication including re-operation for superficial or deep site infection
研究概览
简要总结
Project Summary - Aggressive soft tissue cancers are commonly treated with radiation followed by surgery. These wounds have a very high rate of wound complications and infection (30%), resulting in more surgeries, longer hospital stays and complex nursing care. Previous research shows that negative pressure (vacuum) dressings applied to the incision at the end of surgery can reduce these complications. The Investigator and his team across Canada will perform a clinical trial comparing standard dressings to these vacuum dressings. The results of this study have the potential to immediately improve the quality of life of soft tissue cancer patients. It can also decrease the amount of time required in hospital and reduce the cost to the Canadian healthcare system.
详细描述
This is a multi-center randomized clinical trial lead by the Investigator from the Ottawa Hospital and six other orthopedic cancer centers. The Investigator and the team will be recruiting 248 patients diagnosed with soft tissue cancer who will be treated with radiation therapy followed by surgery. Each of these patients will be randomly assigned to receiving either 7 days of vacuum dressing (Incisional Negative Pressure Wound Therapy) or a standard dressing. Besides this, patients will receive as identical care as possible. The team will then closely follow these patients over a period of 4 month to examine differences in wound complications, length of hospital stay, patient quality of life, patient satisfaction and function. Statistical analysis will be completed by The Ottawa Methods Center and ethical approval will be obtained at each participating site.
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 (Participant, Outcomes Assessor)
盲法说明
The operative team will remain blinded to the dressing until the time of application. Since wound failure requires the need of medical or surgical intervention, primary outcome of this study is not blinded. However, the treatment arm will be blinded to the Research Coordinator/Outcomes Assessor of secondary outcomes including scar assessment, QoL and Functional Assessment.
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
- •Patients 18 years of age and older and are able to provide written consent.
- •Patients with lower extremity soft tissue sarcoma confirmed by tissue pathology.Each patient must have local cross sectional imaging (CT or MRI) and a staging CT chest.
- •Patients eligible for treatment with preoperative radiation therapy followed by limb salvage surgery.
- •Patients for which a primary closure must be attained at the time of surgery.
- •Patient must be available for postoperative follow-up at the treating center.
排除标准
- •Patients who are less than 18 years of age.
- •Patients with a benign disease or with prior radiation to the anatomic region in the remote past (not associated with current treatment radiation plans).
- •Patients who underwent surgical amputation
- •Patients in which primary closure was not achieved (including free flaps and split thickness skin grafts).
- •Patients with a life expectancy less than 120 days.
- •Patients who have an allergy or sensitivity to adhesive dressings.
研究组 & 干预措施
VAC Wound Dressing
Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive 7 days of Incisional Negative pressure wound therapy.
干预措施: Incisional Negative Pressure Wound Therapy (INPWT) (Other)
Control Wound Dressing
Limb salvage surgery is performed on sarcoma patients 4-6 week post radiotherapy. These patients will be randomized to receive standard gauze dressing with no negative pressure application.
干预措施: Wound Dressing (Other)
结局指标
主要结局
Wound Complication including re-operation for superficial or deep site infection
时间窗: 120 days post op
* Wound requiring deep wound packing to an area greater than 2cm in length * Wound requiring persistent dressing changes for greater than 6 weeks. Wound packing and persistent requirement to change the dressing will reflect if the patient has a wound complication.
次要结局
- Functional outcome(120 days postop)
- Overall cost(120 days)
- patient satisfaction(All within this 120 day post-op)
研究者
Dr. J. Werier
Orthopedic Oncologist Surgeon
Ottawa Hospital Research Institute