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研究 PermeaDerm 用作手术伤口临时敷料的临床结果和相关成本的随机对照试验

2026年9月21日 更新者：Avita Medical

一项前瞻性上市后多中心随机对照临床研究，旨在调查 PermeaDerm 用作临时敷料来处理手术伤口时的临床结果和相关成本

The goal of this study is to compare the cost and clinical outcomes for two temporary dressings (Allograft and PermeaDerm) used in patients that need a skin graft to heal their wound. The researchers will review cost and other treatment results including how well both temporary dressings attach to the skin, how prepared the wound bed is to receive a skin graft, how long it takes for the skin to be ready to receive a skin graft, how well the skin graft takes and any complications. Patients will first have the temporary dressing applied to their wound, then a few days later, a skin graft will be performed. Patients will have photos of their wounds taken throughout the study including at all the clinic check-ups with the last check-up occurring about 8 weeks after treatment.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a prospective two-arm randomized multicenter controlled study to evaluate the clinical outcomes and economic impact of PermeaDerm and frozen human cadaveric allograft (FHCA) when they are used as a temporary dressing on surgical wounds where autografting is clinically indicated.

Patients hospitalized within 3 days of injury with a surgical wound up to 30% (inclusive) total body surface area (TBSA) will be considered for participation in this study.

Patients will undergo surgical excision within five days post-injury and will be randomly assigned (1:1) to receive PermeaDerm or FHCA as a temporary dressing. One contiguous area will be selected by the investigator as the study treatment area. Any other areas that require a temporary dressing must be dressed per the randomization.

In addition to economic impact, the two temporary dressings will be compared with respect to adherence, wound bed preparation, time to autografting, graft take, and safety-related adverse events.

Following placement of the temporary dressing, investigators will evaluate the wound every 2-3 days. The temporary dressing may be replaced, per the randomization, as clinically indicated. When the study area is ready for autografting, the temporary dressing will be removed, and the study area will be autografted per the investigative site's standard of care. The donor area(s) may be dressed in PermeaDerm or the investigative site's standard of care.

Post-autografting, subjects will be followed for 8 weeks. Treatment-related and serious adverse events will be reported through the duration of the study. At all visits, subjects' study treatment areas and donor sites that are dressed in PermeaDerm will be documented using digital photography.

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85008
        • Valleywise Health
    • District of Columbia
      • Washington D.C.、District of Columbia、美国、20010
        • Medstar Washington Hospital Center
    • Georgia
      • Atlanta、Georgia、美国、30303
        • Grady Memorial
    • Iowa
      • Iowa City、Iowa、美国、52242
        • Univ of Iowa
    • Kansas
      • Kansas City、Kansas、美国、66160
        • University of Kansas
    • Kentucky
      • Louisville、Kentucky、美国、40202
        • Univ of Louisville Burn Center
    • Louisiana
      • New Orleans、Louisiana、美国、70112
        • University Medical Center
    • New York
      • Rochester、New York、美国、14642
        • University of Rochester
    • North Carolina
      • Winston-Salem、North Carolina、美国、27157
        • Atrium Health Wake Forest Baptist
    • Ohio
      • Akron、Ohio、美国、44308
        • Akron Children's Hospital
      • Columbus、Ohio、美国、43210
        • Ohio State University
    • Tennessee
      • Memphis、Tennessee、美国、38163
        • Regional One Firefighter's Burn Center
    • Virginia
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Subjects must meet all the following criteria to be eligible for participation:

  1. The patient's wound requires temporary dressing coverage after surgical excision and prior to autografting.

  2. The patient has a surgical wound up to 30% (inclusive) total body surface area (TBSA).

  3. The study area is a contiguous area. If the patient has other areas (non-study treatment area) that require temporary dressing, these areas must also be dressed according to the randomization.

  4. The patient is hospitalized within 3 days of injury.

  5. The surgical excision occurs within 5 days post-injury.

  6. The patient (or parent/guardian/legally authorized representative) is willing and able to comply with all study procedures and visit schedule.

  7. The patient (or parent/guardian/legally authorized representative) agrees to abstain from any other treatment of the study area or enrollment in another interventional clinical trial for the duration of his/her participation in the study (8 weeks post-autografting).

  8. In the opinion of the investigator, the patient (or parent/guardian/legally authorized representative) must be able to:

    1. Understand the full nature and purpose of the study, including possible risks and adverse events,
    2. Understand instructions, and
    3. Provide voluntary written informed consent.

Exclusion Criteria:

Subjects who meet any of the following criteria are not eligible for participation:

  1. The study area has received prior surgical intervention.

  2. The patient is currently using medications or treatments such as systemic corticosteroids, chemotherapy, or immunosuppressants, that in the investigator's opinion may compromise patient safety or trial objectives.

  3. Clinical signs of wound infection at study area that in the investigator's opinion may compromise patient safety or trial objectives.

  4. The patient has any of the following

    1. morbid obesity (BMI >40),
    2. immunodeficiency,
    3. venous insufficiency/PVD of the lower extremities (when study area is also in this location),
    4. chronic malnourishment,
    5. inhalation injury (>Grade 1 based on AIS grading scale),
    6. current abuser of alcohol and/or illicit drugs based upon medical history and/or lab results,
    7. diabetes mellitus with HbA1c >9.0%, and/or
    8. advanced renal disease (eGFR <59) or liver disease (LFTs >2.5 times the upper limit).

  5. The patient has any another condition, that in the investigator's opinion may compromise patient safety or the trial objectives.

  6. The patient is unable to understand English or Spanish.

  7. The patient has a known hypersensitivity to bovine-derived collagen materials, porcine, aloe vera materials, or contraindications to the frozen human cadaveric allograft.

  8. The patient's life expectancy is less than 1 year.

    -

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：PermeaDerm 临时生物合成伤口基质
设备：PermeaDerm Biosynthetic Wound Matrix

Study participants randomized (1:1) to this arm will receive PermeaDerm Biosynthetic Wound Matrix prior to skin graft.
实验性的：冷冻人类尸体同种异体移植物 (FHCA)
设备：Frozen Human Cadaveric Allograft (FHCA)

Study participant randomized (1:1) to this arm will receive Frozen Human Cadaveric Allograft (FHCA) prior to skin graft.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Reduction of Cost per Total Body Surface Area (TBSA)
大体时间：8 weeks post treatment.

The reduction of cost per TBSA when PermeaDerm is used as a temporary dressing. The reduction in cost is hypothesized to be superior for PermeaDerm as compared to FHCA.
8 weeks post treatment.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Avita Medical

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月21日

初级完成 (实际的)

2026年3月18日

研究完成 (实际的)

2026年5月8日

研究注册日期

首次提交

2024年12月20日

首先提交符合 QC 标准的

2024年12月20日

首次发布 (实际的)

2024年12月27日

研究记录更新

最后更新发布 (实际的)

2026年9月23日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • CTP012

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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