A prospective, observational, Post Market Clinical Follow-up (PMCF) study in patients using 3M™KerraCel™ Gelling Fiber dressing

KCI (United States)0 个研究点目标入组 48 人开始时间: 2021年11月15日最近更新: 2024年4月8日

适应症

试验速览

暂无简介。

•Current inclusion criteria as of 18/03/2022:
•1. Subjects who have been diagnosed with an oncological wound (e.g. radiation burns, cancerous wounds, and surgical wounds once the cancerous tissue has been removed), or traumatic wound (e.g. abrasions and lacerations), or cavity wound (wounds in a cavity) or skin donor site
•2. Must be able to provide informed consent
•3. Only one wound may be treated per subject for the study
•4. Aged =22 years
•Previous inclusion criteria:
•1. Subjects who have been diagnosed with an oncological wound (e.g. radiation burns, cancerous wounds, and surgical wounds once the cancerous issue has been removed) or traumatic (e.g. abrasions and lacerations) wound.
•2. Must be able to provide informed consent.
•3. Only one wound may be treated per subject for the study.
•4. Age =22 years.

•Current exclusion criteria as of 18/03/2022:
•1. Has a known allergy to the dressing material
•2. Has a wound that has uncontrolled heavy bleeding
•3. Wound or burn larger than 20 cm in any direction
•4. Pregnant or breastfeeding
•Previous exclusion criteria:
•1. Has a wound that requires packing of a body cavity with the KerraCel™ dressing, per the manufacturer’s instructions for use.
•2. Has a wound that has not achieved hemostasis, per the manufacturer’s instructions for use.
•3. Wound or burn larger than 20cm in any direction.
•4. Pregnant or breastfeeding.

发起方

KCI (United States)