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临床试验/NCT07120386
NCT07120386招募中不适用

Instillation vs Traditional Negative Pressure Wound Therapy: A Pilot Randomized Controlled Trial for Necrotizing Soft Tissue Infections (NPWTi-NSTI Trial)

HealthPartners Institute2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Unplanned hospital readmission

研究概览

简要总结

Necrotizing Soft Tissue Infections (NSTIs) are rapidly progressing infections that have a high morbidity and mortality, with the greatest morbidity related to managing the large wounds required to treat these patients. Initial treatment requires wide surgical removal of infected tissue and optimal management is essential to reducing morbidity in these patients. Negative pressure wound therapy (NPWT) is a widely used technology that has revolutionized wound management. NPWT is utilized across the spectrum of acute wounds, including routine postoperative incision management, traumatic wounds, and wounds related to surgical debridement of NSTIs which are frequently some of the most complicated of wounds encountered. Most NSTI cases at Regions Hospital currently utilize negative pressure wound therapy with instillation (NPWTi) where the wound is irrigated to clean out debris. Currently, there is a paucity of data comparing traditional NPWT and NPWTi and the choice of which device to use is left to surgeon discretion. This study is a first step at identifying the effects of NPWTi compared to NPWT alone on the care of NSTI patients. If the theoretical benefits of NPWTi over NPWT translate to practice, those treated with NPWTi would be expected to have a reduced rate of hospital readmission after their index hospitalization in addition to shorter time to definitive closure/coverage. This is a pilot study to assess the feasibility of enrolling patients with NSTIs in a randomized controlled trial to assess outcomes between the two devices.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • Clinical suspicion for Necrotizing Soft Tissue Infection (NSTI) necessitating emergent operative intervention
  • Age >/=18 years old
  • Planned application of a negative pressure wound dressing

排除标准

  • Patients who have a wound that does not allow for a wound vac
  • Patients receiving acute treatment for a NSTI at another institution
  • Incarcerated patients
  • Patients who do not survive to wound closure/coverage
  • Patients <18 years old

结局指标

主要结局

Unplanned hospital readmission

时间窗: Within 30 days of discharge

Did the patient have an unplanned readmission to the hospital (Y/N) within 30 days of discharge

Rate of healing

时间窗: First operation and last operation

Time from index debridement to final coverage in days

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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