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临床试验/NCT05898711
NCT05898711进行中(未招募)不适用

Quality and Safety Outcomes: Prospective Follow Up Registry on FDA Cleared Acellular Fish Skin Grafts in Soft Tissue Reinforcement.

Kerecis Ltd.1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Kerecis Ltd.
入组人数
200
试验地点
1
主要终点
Number of surgical complication: dehiscence, infection

研究概览

简要总结

Registry Objectives The overall objective of the registry is to collect quality and safety data to assess the long-term outcomes of Kerecis Omega3 SurgiBind in surgical procedures to reinforce soft tissue and prevent surgical complications. The ultimate goal of the registry is to enhance the quality of care, patient outcomes and establish a resource to facilitate the use of fish skin in preventing surgical wound dehiscence and surgical site infection.

详细描述

This Registry is a non-experiment non-interventional case registry to collect quality and safety data on patients that have been treat with the Kerecis product SurgiBind as their regular operative plan from their health care provider.

Primary Objective To collect and quantify patient safety and quality outcomes on a commercially available FDA cleared product Kerecis Omega3 SurgiBind utilized in surgical treatment to reinforce soft tissue and preventing surgical complications (dehiscence and infection).

Secondary Objective To assess the applicable complications post-surgery following the use of fish skin regarding time to heal, time to physical therapy, length of stay, etc.

Registry Procedures Specific Training Prior to patient enrollment, the Sponsor will initiate in person or virtual site visit with participating sites to provide training to the physicians and their staff about the protocol, registry procedures and data entry. The Sponsor will implement a number of strategies to ensure the quality, consistency and interpretability of data recorded. Training, education and ongoing liaison with participating sites will be provided to support high quality data collection.

Recruitment of participants Patients contacting the participating site to schedule the appointment for consultation about their upcoming surgery will be informed about the registry and will be given the option to participate. When the patient comes to the clinic for their visit, information regarding registry participation will be provided by a qualified research staff member. This oral information will be provided while the person is in a private room. Patients can also be recruited through recommendation from their doctors and health care providers.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion Criteria
  • Age 18 and older
  • Undergoing surgical procedure requiring soft tissue reinforcement with Kerecis Omega3 SurgiBind
  • For example:
  • Plastic reconstructive surgery
  • Orthopedic surgery
  • Cardiothoracic surgery
  • Vascular Surgery
  • General Surgery

排除标准

  • Participants who request not to be in the registry
  • Life expectancy of less than 1 year

结局指标

主要结局

Number of surgical complication: dehiscence, infection

时间窗: 12 months

quantify the number of patients who experience postoperative wound complications including dehiscence and infection. Patients undergoing surgical procedures and experience wound complications are captured. Wound dehiscence will be categorized as superficial or deep. Infection (if appears) will be identified and recorded. Wounds are considered infected if the wound margins are erythematous and have one or combined of the following: active purulence or necrosis of underlying soft tissues.

次要结局

  • Time to healing:(12 months)
  • Time to physical therapy initiation(12 months)
  • Duration of physical therapy(12 months)

研究者

发起方
Kerecis Ltd.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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