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临床试验/NCT02638298
NCT02638298已完成不适用

Incisional Negative Pressure Wound Therapy for Preoperatively Irradiated Lower Extremity Soft Tissue Sarcoma Wounds. A Prospective Randomized Clinical Trial

Medical University of South Carolina2 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2015年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
163
试验地点
2
主要终点
Wound Complication Rate

研究概览

简要总结

This is a study comparing two methods of dressing a post operative wound that are currently in practice. One method is a traditional dry gauze dressing. The other method is using a negative pressure dressing that provides gentle suction on the wound.

The investigators will attempt to determine how well the use of post-operative negative pressure dressing reduces wound healing problems in patients who have surgery after radiation for a sarcoma in the thigh or leg.

详细描述

Postoperative surgical site infections pose a significant challenge to the orthopaedic oncologist, especially in wounds that have been previously irradiated with neo adjuvant external beam radiation therapy (EBRT). There are many studies demonstrating the relatively high risk of wound complications after lower extremity sarcoma resection. Published data suggest that these preoperatively radiated wounds have a postoperative infection rate of 17%-44% with "traditional" dressings (e.g. dry gauze surgical dressings).

A prospective series of 190 patients and showed a wound complication risk of 35% in preoperative irradiated wounds. The morbidity associated with wound complications can range from moderate (prolonged dressing changes) to severe (life or limb threatening infection). Patients who develop wound complications have been shown to longer hospitalizations and higher costs [ref]. Anatomic location of the tumor has been shown to be a risk factor for the development of wound complications with lower extremities being higher risk than upper extremities. There are several published studies examining the effect of negative pressure wound therapy (NPWT) on high risk surgical wounds. Abdominal wound complications can be reduced with the use of incisional NPWT. In the orthopaedic literature the use of negative pressure incisional dressings have been shown to lower the risk of wound complications in total hip arthroplasty, acetabular fractures, and extremity fractures.

To our knowledge, there have not been any published studies on the utility of negative pressure wound therapy in previously irradiated soft tissue sarcoma wounds. The investigators feel that this high risk patient cohort could potentially benefit from reducing wound complications through NPWT and is an ideal population to study its effect.

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

入选标准

  • Willing to consent to randomization and able to participate in the study
  • Lower extremity soft tissue sarcoma necessitating radiation prior to surgical resection
  • Primary closure of wound
  • Patients scheduled for surgical resection

排除标准

  • Flap coverage or skin graft
  • Patients scheduled for amputations as local control of their tumor
  • Sarcomas where radiation is not planned preoperatively
  • Repeat surgeries for oncologic reasons (positive margins)
  • Known allergy to adhesive tape

结局指标

主要结局

Wound Complication Rate

时间窗: longitudinally up to 6 months postoperatively

To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).

Wound Complication Rate

时间窗: longitudinally up to 6 months postoperatively

To estimate the wound complication rate of post-operative negative pressure dressings and traditional dry dressings, and risk of secondary interventions after resection of soft tissue sarcoma in lower extremities that have received pre-operative radiation. Post-operative pain severity assessed by Visual analogue scale at 2 weeks and 6 months post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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