ISRCTN33932204
Completed
Phase 4
A prospective, observational, Post Market Clinical Follow-up (PMCF) study in patients using 3M™KerraCel™ Gelling Fiber dressing
KCI (United States)0 sites48 target enrollmentNovember 15, 2021
ConditionsOncological wounds (e.g. radiation burns, cancerous wounds and surgical wounds once the cancerous tissue has been removed), traumatic wounds (e.g. abrasions and lacerations), cavity wounds (such as abdominal or thoracic) and wounds created from skin donor sitesInjury, Occupational Diseases, Poisoning
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Oncological wounds (e.g. radiation burns, cancerous wounds and surgical wounds once the cancerous tissue has been removed), traumatic wounds (e.g. abrasions and lacerations), cavity wounds (such as abdominal or thoracic) and wounds created from skin donor sites
- Sponsor
- KCI (United States)
- Enrollment
- 48
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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