Randomized Study Comparing Negative Pressure Dressing Versus Conventional Dressing in Patients With Resected Limb or Trunk Soft Tissue Sarcoma (STS) After External Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 166
- 试验地点
- 30
- 主要终点
- The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
研究概览
简要总结
This is a randomized (1:1 ratio), prospective, comparative, controlled, open-label study. The aim is to compare the efficacy of negative pressure therapy (PREVENA™) versus standard postoperative wound management on the wound healing after surgery for previously irradiated Soft Tissue Sarcoma (STS)
详细描述
The gold standard treatment for primary non-metastatic STS is complete surgical resection. Peri-operative Radiation Therapy (RT) has been proved to improve local control . Nevertheless, the timing of RT, whether preoperative or postoperative, remains a debate.
Both have similar local control efficacy, but preoperative RT results in lower rates of long-term fibrosis and lymphedema and improved joint mobility than postoperative RT. On the other hand, the adverse effect of pre-operative RT is a higher rate of wound post-operative complications and re-operations.
Any effort to reduce the high rate of postoperative complications could offer the advantage of preoperative RT in terms of reduced long-term sequelae compared with postoperative RT without a higher wound complication rate postoperatively. Short retrospective series of Negative Pressure Wound Therapy (NPWT) after surgical resection of Soft Tissue Sarcoma (STS) have reported very encouraging results in preventing wound complications: patients treated with NPWT were less likely to develop wound complications than those who did not receive it. Both groups did not report an increased rate of local recurrence. The use of NPWT would also reduce the cost of care by avoiding complications.
That's why the investigators propose this study comparing the use of a negative pressure dressing to a conventional dressing in patients with STS of the limbs or trunk resected after neo-adjuvant external radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Age ≥ 18 years at the day of consenting to the study
- •Patients with primary STS of the limb or trunk treated with preoperative external radiation therapy (decided in multidisciplinary board)
- •Intent to cure resection required for STS planned between 3 to 8 weeks after the end of RT
- •Planned primary wound closure, including local or distant jambeau
- •Ability to understand and willingness for follow-up visits
- •Covered by a medical insurance
- •Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
排除标准
- •Known hypersensibility to silver
- •Patients with a diagnosis of Ewing's sarcoma, chondrosarcoma, osteosarcoma, or desmoid tumor. Nota bene: Only patients with bone tumors are affected; patients with soft tissue tumors can be included in the study.
- •Patient in relapse setting;
- •Patient requiring a surgical revision after R1 or R2 resection;
- •Planned blade drainage;
- •Planned no wound-closure and skin graft after resection
- •Patient requiring authorship or curators or patient deprived of liberty.
研究组 & 干预措施
Arm A : Surgery for STS and prevena
The surgery for the STS lesion will be performed according to standard practices.
PREVENA™ Incision Management System should be applied immediately post-surgery to clean surgically closed wounds. It should be continuously applied for a minimum of 2 days and up to a maximum of 7 days (as per PREVENA user manual)
干预措施: Prevena (Device)
Arm B : Surgery for STS and standard postoperative wound management
The surgery for the STS lesion will be performed according to standard practices.
The dressing and drainage of the wound will be performed according to usual practices, with the exception of negative pressure dressings.
结局指标
主要结局
The efficacy of negative pressure therapy (PREVENA) versus standard postoperative wound management on the wound healing after surgery for previously irradiated STS
时间窗: Within the 3-month postoperative period.
Assessed by major wound complications rate
次要结局
- Three months secondary surgery for wound healing problem rate(At 3 months post-surgery visit)
- Quality of life using EQ-5D-5L(At 28 days and 3 months after surgery for each patients)
- Three month deep infection rate(At 3 months post-surgery visit)
- Hospitalization duration(At 3 months post-surgery visit)
- Time to complete wound healing(Up to 27 months)
- Incidence of Adverse Events(Up to 27months)
- Number and types of major wound complications (MWCs)(Up to 27 months)
- Quality of life using FACT-G(At 28 days and 3 months after surgery for each patients)